A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmac

A Randomized, Double-Blind, Placebo Controlled, Single Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK3888130B in Healthy Participants Aged 18-55 Inclusive

CompletedPhase 1MS (type not specified)NCT05131971

What it found

Results posted, not judged

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

  • GSK3888130B

Placebo

  • Placebo

Results by group

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Up to 160 days

GroupValueIntervalNumber analysed
Placebo8 Participants15
GSK3888130B Dose Level 1 IV3 Participants3
GSK3888130B Dose Level 2 IV2 Participants3
GSK3888130B Dose Level 3 SC6 Participants6
GSK3888130B Dose Level 4 IV2 Participants6
GSK3888130B Dose Level 5 SC4 Participants6
GSK3888130B Dose Level 6 IV8 Participants9
GSK3888130B Dose Level 7 IV5 Participants6
Placebo0 Participants15
GSK3888130B Dose Level 1 IV0 Participants3
GSK3888130B Dose Level 2 IV0 Participants3
GSK3888130B Dose Level 3 SC0 Participants6
GSK3888130B Dose Level 4 IV0 Participants6
GSK3888130B Dose Level 5 SC0 Participants6
GSK3888130B Dose Level 6 IV0 Participants9
GSK3888130B Dose Level 7 IV0 Participants6

Number of Participants With Clinically Significant Changes in Hematology Results

Up to 85 days

GroupValueIntervalNumber analysed
Placebo0 Participants15
GSK3888130B Dose Level 1 IV0 Participants3
GSK3888130B Dose Level 2 IV0 Participants3
GSK3888130B Dose Level 3 SC0 Participants6
GSK3888130B Dose Level 4 IV0 Participants6
GSK3888130B Dose Level 5 SC0 Participants6
GSK3888130B Dose Level 6 IV0 Participants9
GSK3888130B Dose Level 7 IV0 Participants6

Number of Participants With Worst-case Cluster of Differentiation (CD) 4+ T Cell Counts Results by Maximum Grade Increase Post-Baseline Relative to Baseline

Baseline (Day 1) and up to 85 days

GroupValueIntervalNumber analysed
Placebo4 Participants15
GSK3888130B Dose Level 1 IV1 Participants3
GSK3888130B Dose Level 2 IV1 Participants3
GSK3888130B Dose Level 3 SC1 Participants6
GSK3888130B Dose Level 4 IV1 Participants6
GSK3888130B Dose Level 5 SC3 Participants6
GSK3888130B Dose Level 6 IV5 Participants9
GSK3888130B Dose Level 7 IV4 Participants6
Placebo0 Participants15
GSK3888130B Dose Level 1 IV0 Participants3
GSK3888130B Dose Level 2 IV0 Participants3
GSK3888130B Dose Level 3 SC0 Participants6
GSK3888130B Dose Level 4 IV0 Participants6
GSK3888130B Dose Level 5 SC0 Participants6
GSK3888130B Dose Level 6 IV0 Participants9
GSK3888130B Dose Level 7 IV0 Participants6
Placebo0 Participants15
GSK3888130B Dose Level 1 IV0 Participants3
GSK3888130B Dose Level 2 IV0 Participants3
GSK3888130B Dose Level 3 SC0 Participants6
GSK3888130B Dose Level 4 IV0 Participants6
GSK3888130B Dose Level 5 SC0 Participants6
GSK3888130B Dose Level 6 IV0 Participants9
GSK3888130B Dose Level 7 IV0 Participants6

Number of Participants With Worst-case Creatinine Results by Maximum Grade Increase Post-Baseline Relative to Baseline

Baseline (Day 1) and up to 85 days

GroupValueIntervalNumber analysed
Placebo0 Participants15
GSK3888130B Dose Level 1 IV0 Participants3
GSK3888130B Dose Level 2 IV0 Participants3
GSK3888130B Dose Level 3 SC0 Participants6
GSK3888130B Dose Level 4 IV0 Participants6
GSK3888130B Dose Level 5 SC0 Participants6
GSK3888130B Dose Level 6 IV1 Participants9
GSK3888130B Dose Level 7 IV0 Participants6
Placebo0 Participants15
GSK3888130B Dose Level 1 IV0 Participants3
GSK3888130B Dose Level 2 IV0 Participants3
GSK3888130B Dose Level 3 SC0 Participants6
GSK3888130B Dose Level 4 IV0 Participants6
GSK3888130B Dose Level 5 SC0 Participants6
GSK3888130B Dose Level 6 IV0 Participants9
GSK3888130B Dose Level 7 IV0 Participants6
Placebo0 Participants15
GSK3888130B Dose Level 1 IV0 Participants3
GSK3888130B Dose Level 2 IV0 Participants3
GSK3888130B Dose Level 3 SC0 Participants6
GSK3888130B Dose Level 4 IV0 Participants6
GSK3888130B Dose Level 5 SC0 Participants6
GSK3888130B Dose Level 6 IV0 Participants9
GSK3888130B Dose Level 7 IV0 Participants6

Number of Participants With Clinically Significant Changes in Clinical Chemistry Results

Up to 85 days

GroupValueIntervalNumber analysed
Placebo0 Participants15
GSK3888130B Dose Level 1 IV0 Participants3
GSK3888130B Dose Level 2 IV0 Participants3
GSK3888130B Dose Level 3 SC0 Participants6
GSK3888130B Dose Level 4 IV0 Participants6
GSK3888130B Dose Level 5 SC0 Participants6
GSK3888130B Dose Level 6 IV0 Participants9
GSK3888130B Dose Level 7 IV0 Participants6

Number of Participants With Worst-case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline

Baseline (Day 1) and up to 85 days

GroupValueIntervalNumber analysed
Placebo0 Participants15
GSK3888130B Dose Level 1 IV0 Participants3
GSK3888130B Dose Level 2 IV0 Participants3
GSK3888130B Dose Level 3 SC0 Participants6
GSK3888130B Dose Level 4 IV0 Participants6
GSK3888130B Dose Level 5 SC0 Participants6
GSK3888130B Dose Level 6 IV0 Participants9
GSK3888130B Dose Level 7 IV0 Participants6
Placebo0 Participants15
GSK3888130B Dose Level 1 IV0 Participants3
GSK3888130B Dose Level 2 IV0 Participants3
GSK3888130B Dose Level 3 SC1 Participants6
GSK3888130B Dose Level 4 IV0 Participants6
GSK3888130B Dose Level 5 SC2 Participants6
GSK3888130B Dose Level 6 IV1 Participants9
GSK3888130B Dose Level 7 IV0 Participants6
Placebo0 Participants15
GSK3888130B Dose Level 1 IV0 Participants3
GSK3888130B Dose Level 2 IV0 Participants3
GSK3888130B Dose Level 3 SC1 Participants6
GSK3888130B Dose Level 4 IV0 Participants6
GSK3888130B Dose Level 5 SC0 Participants6
GSK3888130B Dose Level 6 IV0 Participants9
GSK3888130B Dose Level 7 IV0 Participants6
Placebo1 Participants15
GSK3888130B Dose Level 1 IV0 Participants3
GSK3888130B Dose Level 2 IV0 Participants3
GSK3888130B Dose Level 3 SC0 Participants6
GSK3888130B Dose Level 4 IV0 Participants6
GSK3888130B Dose Level 5 SC0 Participants6
GSK3888130B Dose Level 6 IV0 Participants9
GSK3888130B Dose Level 7 IV1 Participants6
Placebo0 Participants15
GSK3888130B Dose Level 1 IV0 Participants3
GSK3888130B Dose Level 2 IV0 Participants3
GSK3888130B Dose Level 3 SC0 Participants6
GSK3888130B Dose Level 4 IV0 Participants6
GSK3888130B Dose Level 5 SC0 Participants6
GSK3888130B Dose Level 6 IV0 Participants9
GSK3888130B Dose Level 7 IV0 Participants6
Placebo0 Participants15
GSK3888130B Dose Level 1 IV1 Participants3
GSK3888130B Dose Level 2 IV0 Participants3
GSK3888130B Dose Level 3 SC0 Participants6
GSK3888130B Dose Level 4 IV0 Participants6
GSK3888130B Dose Level 5 SC0 Participants6
GSK3888130B Dose Level 6 IV0 Participants9
GSK3888130B Dose Level 7 IV0 Participants6
Placebo0 Participants15
GSK3888130B Dose Level 1 IV0 Participants3
GSK3888130B Dose Level 2 IV0 Participants3
GSK3888130B Dose Level 3 SC0 Participants6
GSK3888130B Dose Level 4 IV0 Participants6
GSK3888130B Dose Level 5 SC0 Participants6
GSK3888130B Dose Level 6 IV1 Participants9
GSK3888130B Dose Level 7 IV2 Participants6
Placebo8 Participants15
GSK3888130B Dose Level 1 IV3 Participants3
GSK3888130B Dose Level 2 IV2 Participants3
GSK3888130B Dose Level 3 SC4 Participants6
GSK3888130B Dose Level 4 IV5 Participants6
GSK3888130B Dose Level 5 SC6 Participants6
GSK3888130B Dose Level 6 IV5 Participants9
GSK3888130B Dose Level 7 IV6 Participants6
Placebo0 Participants15
GSK3888130B Dose Level 1 IV0 Participants3
GSK3888130B Dose Level 2 IV0 Participants3
GSK3888130B Dose Level 3 SC0 Participants6
GSK3888130B Dose Level 4 IV0 Participants6
GSK3888130B Dose Level 5 SC0 Participants6
GSK3888130B Dose Level 6 IV0 Participants9
GSK3888130B Dose Level 7 IV0 Participants6
Placebo12 Participants15
GSK3888130B Dose Level 1 IV3 Participants3
GSK3888130B Dose Level 2 IV2 Participants3
GSK3888130B Dose Level 3 SC5 Participants6
GSK3888130B Dose Level 4 IV4 Participants6
GSK3888130B Dose Level 5 SC6 Participants6
GSK3888130B Dose Level 6 IV8 Participants9
GSK3888130B Dose Level 7 IV5 Participants6

Number of Participants With Clinically Significant Changes in Vital Sign Results

Up to 85 days

GroupValueIntervalNumber analysed
Placebo0 Participants15
GSK3888130B Dose Level 1 IV0 Participants3
GSK3888130B Dose Level 2 IV0 Participants3
GSK3888130B Dose Level 3 SC0 Participants6
GSK3888130B Dose Level 4 IV0 Participants6
GSK3888130B Dose Level 5 SC0 Participants6
GSK3888130B Dose Level 6 IV0 Participants9
GSK3888130B Dose Level 7 IV0 Participants6

Number of Participants With Positive Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) and Varicella Zoster Virus (VZV) DNA

Baseline (Day 1), Day 15 and Day 85

GroupValueIntervalNumber analysed
Placebo0 Participants15
GSK3888130B Dose Level 1 IV0 Participants3
GSK3888130B Dose Level 2 IV0 Participants3
GSK3888130B Dose Level 3 SC0 Participants6
GSK3888130B Dose Level 4 IV0 Participants6
GSK3888130B Dose Level 5 SC0 Participants6
GSK3888130B Dose Level 6 IV0 Participants9
GSK3888130B Dose Level 7 IV0 Participants6
Placebo0 Participants15
GSK3888130B Dose Level 1 IV0 Participants3
GSK3888130B Dose Level 2 IV0 Participants3
GSK3888130B Dose Level 3 SC0 Participants6
GSK3888130B Dose Level 4 IV0 Participants6
GSK3888130B Dose Level 5 SC0 Participants6
GSK3888130B Dose Level 6 IV0 Participants9
GSK3888130B Dose Level 7 IV0 Participants6
Placebo0 Participants15
GSK3888130B Dose Level 1 IV0 Participants3
GSK3888130B Dose Level 2 IV0 Participants3
GSK3888130B Dose Level 3 SC0 Participants6
GSK3888130B Dose Level 4 IV0 Participants6
GSK3888130B Dose Level 5 SC0 Participants6
GSK3888130B Dose Level 6 IV0 Participants9
GSK3888130B Dose Level 7 IV0 Participants6
Placebo0 Participants15
GSK3888130B Dose Level 1 IV0 Participants3
GSK3888130B Dose Level 2 IV0 Participants3
GSK3888130B Dose Level 3 SC0 Participants6
GSK3888130B Dose Level 4 IV0 Participants6
GSK3888130B Dose Level 5 SC0 Participants6
GSK3888130B Dose Level 6 IV0 Participants9
GSK3888130B Dose Level 7 IV0 Participants6
Placebo0 Participants15
GSK3888130B Dose Level 1 IV0 Participants3
GSK3888130B Dose Level 2 IV0 Participants3
GSK3888130B Dose Level 3 SC0 Participants6
GSK3888130B Dose Level 4 IV0 Participants6
GSK3888130B Dose Level 5 SC0 Participants6
GSK3888130B Dose Level 6 IV0 Participants9
GSK3888130B Dose Level 7 IV0 Participants6
Placebo0 Participants15
GSK3888130B Dose Level 1 IV0 Participants3
GSK3888130B Dose Level 2 IV0 Participants3
GSK3888130B Dose Level 3 SC0 Participants6
GSK3888130B Dose Level 4 IV0 Participants6
GSK3888130B Dose Level 5 SC0 Participants6
GSK3888130B Dose Level 6 IV0 Participants9
GSK3888130B Dose Level 7 IV0 Participants6

Number of Participants With Positive Epstein-Barr Virus (EBV) DNA

Baseline (Day 1), Day 15 and Day 85

GroupValueIntervalNumber analysed
Placebo0 Participants15
GSK3888130B Dose Level 1 IV1 Participants3
GSK3888130B Dose Level 2 IV0 Participants3
GSK3888130B Dose Level 3 SC0 Participants6
GSK3888130B Dose Level 4 IV0 Participants6
GSK3888130B Dose Level 5 SC1 Participants6
GSK3888130B Dose Level 6 IV0 Participants9
GSK3888130B Dose Level 7 IV1 Participants6
Placebo2 Participants15
GSK3888130B Dose Level 1 IV0 Participants3
GSK3888130B Dose Level 2 IV0 Participants3
GSK3888130B Dose Level 3 SC1 Participants6
GSK3888130B Dose Level 4 IV0 Participants6
GSK3888130B Dose Level 5 SC0 Participants6
GSK3888130B Dose Level 6 IV0 Participants9
GSK3888130B Dose Level 7 IV2 Participants6
Placebo0 Participants15
GSK3888130B Dose Level 1 IV0 Participants3
GSK3888130B Dose Level 2 IV0 Participants3
GSK3888130B Dose Level 3 SC0 Participants6
GSK3888130B Dose Level 4 IV1 Participants6
GSK3888130B Dose Level 5 SC0 Participants6
GSK3888130B Dose Level 6 IV2 Participants9
GSK3888130B Dose Level 7 IV1 Participants6
Placebo0 Participants15
GSK3888130B Dose Level 1 IV0 Participants3
GSK3888130B Dose Level 2 IV0 Participants3
GSK3888130B Dose Level 3 SC0 Participants6
GSK3888130B Dose Level 4 IV0 Participants6
GSK3888130B Dose Level 5 SC0 Participants6
GSK3888130B Dose Level 6 IV1 Participants9
GSK3888130B Dose Level 7 IV0 Participants6
Placebo0 Participants15
GSK3888130B Dose Level 1 IV0 Participants3
GSK3888130B Dose Level 2 IV0 Participants3
GSK3888130B Dose Level 3 SC0 Participants6
GSK3888130B Dose Level 4 IV0 Participants6
GSK3888130B Dose Level 5 SC0 Participants6
GSK3888130B Dose Level 6 IV0 Participants9
GSK3888130B Dose Level 7 IV0 Participants6
Placebo1 Participants15
GSK3888130B Dose Level 1 IV1 Participants3
GSK3888130B Dose Level 2 IV0 Participants3
GSK3888130B Dose Level 3 SC0 Participants6
GSK3888130B Dose Level 4 IV1 Participants6
GSK3888130B Dose Level 5 SC0 Participants6
GSK3888130B Dose Level 6 IV0 Participants9
GSK3888130B Dose Level 7 IV1 Participants6

Number of Participants With Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) Findings

Up to 85 days

GroupValueIntervalNumber analysed
Placebo0 Participants15
GSK3888130B Dose Level 1 IV0 Participants3
GSK3888130B Dose Level 2 IV0 Participants3
GSK3888130B Dose Level 3 SC0 Participants6
GSK3888130B Dose Level 4 IV0 Participants6
GSK3888130B Dose Level 5 SC0 Participants6
GSK3888130B Dose Level 6 IV0 Participants9
GSK3888130B Dose Level 7 IV0 Participants6
Placebo12 Participants15
GSK3888130B Dose Level 1 IV1 Participants3
GSK3888130B Dose Level 2 IV2 Participants3
GSK3888130B Dose Level 3 SC6 Participants6
GSK3888130B Dose Level 4 IV4 Participants6
GSK3888130B Dose Level 5 SC6 Participants6
GSK3888130B Dose Level 6 IV7 Participants9
GSK3888130B Dose Level 7 IV5 Participants6

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Placebo150 (0.0%)0
GSK3888130B Dose Level 1 IV30 (0.0%)0
GSK3888130B Dose Level 2 IV30 (0.0%)0
GSK3888130B Dose Level 3 SC60 (0.0%)0
GSK3888130B Dose Level 4 IV60 (0.0%)0
GSK3888130B Dose Level 5 SC60 (0.0%)0
GSK3888130B Dose Level 6 IV90 (0.0%)0
GSK3888130B Dose Level 7 IV60 (0.0%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Up to 160 days

    Safety

  • Number of Participants With Clinically Significant Changes in Hematology Results

    Up to 85 days

    Immune response

  • Number of Participants With Worst-case Cluster of Differentiation (CD) 4+ T Cell Counts Results by Maximum Grade Increase Post-Baseline Relative to Baseline

    Baseline (Day 1) and up to 85 days

    Immune responseSafety

  • Number of Participants With Worst-case Creatinine Results by Maximum Grade Increase Post-Baseline Relative to Baseline

    Baseline (Day 1) and up to 85 days

  • Number of Participants With Clinically Significant Changes in Clinical Chemistry Results

    Up to 85 days

  • Number of Participants With Worst-case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline

    Baseline (Day 1) and up to 85 days

  • Number of Participants With Clinically Significant Changes in Vital Sign Results

    Up to 85 days

    Safety

  • Number of Participants With Positive Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) and Varicella Zoster Virus (VZV) DNA

    Baseline (Day 1), Day 15 and Day 85

  • Number of Participants With Positive Epstein-Barr Virus (EBV) DNA

    Baseline (Day 1), Day 15 and Day 85

    Immune response

  • Number of Participants With Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) Findings

    Up to 85 days

Other measures (21)

  • Serum Concentrations of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration

    Day 1: Pre-dose, 15 minutes, 30 minutes, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85

    How the body handles the medicineSafety

  • Serum Concentrations of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration

    Day 1: Pre-dose, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85

    How the body handles the medicine

  • Serum Concentrations of GSK3888130B for Dose Levels 6 and 7 IV Administration

    Day 1: Pre-dose, 30 minutes, 1 hour, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85

    How the body handles the medicineSafety

  • Area Under the Concentration-time Curve From Time Zero to Time t (AUC[0 to t]) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration

    Day 1: Pre-dose, 15 minutes, 30 minutes, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85

    How the body handles the medicine

  • AUC(0 to t) for Dose Levels 3 and 5 Subcutaneous Administration

    Day 1: Pre-dose, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85

    How the body handles the medicine

  • AUC(0 to t) for Dose Levels 6 and 7 Intravenous Administration

    Day 1: Pre-dose, 30 minutes, 1 hour, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85

    How the body handles the medicine

  • Maximum Observed Plasma Concentration (Cmax) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration

    Day 1: Pre-dose, 15 minutes, 30 minutes, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85

    How the body handles the medicine

  • Cmax of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration

    Day 1: Pre-dose, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85

    How the body handles the medicine

  • Cmax of GSK3888130B for Dose Levels 6 and 7 Intravenous Administration

    Day 1: Pre-dose, 30 minutes, 1 hour, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85

    How the body handles the medicine

  • Time to Cmax (Tmax) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration

    Day 1: Pre-dose, 15 minutes, 30 minutes, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85

    How the body handles the medicine

Who could take part

MS (type not specified) · 18 to 55

Show the full criteria

Inclusion criteria

* Participant must be 18 to 55 years of age inclusive. * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. * Participants with a confirmed positive vaccination status for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccines administered at least 30 days prior to dosing in the study. * SARS-CoV-2 screening test negative as per local guidance. * Participants with history of current/seasonal vaccination status for influenza or who consent to receive influenza vaccine at least 30 days prior to dosing, if study dosing is during influenza season (1st October to 30th April). * Body weight greater than or equal to (>=) 50 kilograms (kg) and body mass index (BMI) within the range 19.5-32 kilograms per square meter (kg/m\^2) (inclusive). * Male and/or female of non-childbearing potential * Capable of giving signed informed consent.

Exclusion criteria

* Prior medical history of anaphylaxis. * Immunodeficiency or autoimmunity assessed by medical history. * A history of recurrent infections. * Treatment of a chronic infection within 3 months prior to the first dose of study drug. * Any acute infection (including upper respiratory tract infections and urinary tract infections) which has not fully resolved within four weeks of dosing * History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy. * Current or chronic history of liver disease or known hepatic or biliary abnormalities. * Participants with a history of renal disease or renal abnormalities. * A clinically significant abnormality in the 12-lead ECG performed at screening. * A clinically significant abnormality in the Holter monitor performed at screening. * History of malignancy, including malignant or non-malignant skin cancer. * Participants with known SARS-CoV-2 positive contacts in the past 14 days. * Prior moderate/severe SARS-CoV-2 infection requiring oxygen supplementation or admission to hospital. * Antibiotics or antiviral therapy within 30 days of dosing. * Receipt of live vaccination within 30 days of dosing or plan to receive live vaccination during the study. * Use of prescription drugs or non-prescription drugs, including non-steroidal anti inflammatory drug (NSAIDs), within 7 days prior to dosing, if in the opinion of the Investigator (in consultation with the GlaxoSmithKline [GSK] Medical Monitor if required) the medication will interfere with the study procedures or compromise participant safety. * The participant has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day of the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). * Exposure to more than 4 new chemical entities within 12 months prior to dosing. * A positive drug/alcohol test at screening or Day -1 * The participant is at high-risk of Mycobacterium tuberculosis (MTB) infection in the opinion of the Investigator. * History of asthma, allergic rhinitis or atopic dermatitis defined by the need for intermittent or continuous therapy or any other significant allergies that, in the opinion of the investigator contraindicates their participation. * History of severe adverse reaction to local anesthetic. * Presence of keloids or history of keloids. * Prothrombin time (PT) or activated partial thromboplastin time (aPTT) >1.5x upper limit of normal (ULN) at screening. * History or presence of excessive bleeding or coagulation disorders that in the opinion of the Investigator poses a safety risk with regards to participation in the trial. * Presence of tattoos, naevi or other skin abnormalities on the volar forearm Fitzpatrick skin color grades V in the opinion of the investigator, interfere with study assessments * Participating, within 7 days of dosing, in recreational sun-bathing, or use of sunbed, on the area of the skin from wrist to shoulder inclusive. * Current smoker or user of tobacco- or nicotine-containing products (e.g. nicotine patches or vaporizing devices) during or within 30 days prior to study participation. * An average weekly intake of >14 units of alcohol.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

This is a first time in human study designed to assess the safety, tolerability, pharmacokinetics and PD of GSK3888130B over a range of dose levels in healthy participants.

Papers

    Loading reviews and guidelines…

    History

      1. Started

        Nov 2021

      2. Main results due

        Oct 2023

      3. Finished

        Oct 2023

      4. Results posted

        Mar 2025

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