Last updated: 02/11/2025 11:50:09
A study to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics (PD) of GSK3888130B in healthy participants
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Sequential Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Up to 110 days
Number of participants with clinically significant changes in laboratory parameters, vital signs and 12-lead electrocardiogram (ECG) findings
Timeframe: Up to 85 days
Secondary outcomes:
Serum concentrations of GSK3888130B
Timeframe: Up to 85 days
Area under the concentration-time curve from time zero to time t (AUC[0 to t]) of GSK3888130B
Timeframe: Up to 85 days
Maximum concentration (Cmax) of GSK3888130B in serum
Timeframe: Up to 85 days
Time to Cmax (Tmax) of GSK3888130B
Timeframe: Up to 85 days
Half-life (t1/2) of GSK3888130B
Timeframe: Up to 85 days
Clearance (CL) of GSK3888130B
Timeframe: Up to 85 days
Number of participants with positive anti-drug antibodies against GSK3888130B
Timeframe: Up to 85 days
Change from Baseline in derived free Interleukin-7 (IL-7) protein levels over time
Timeframe: Baseline (Day 1) and up to 85 days
Change in PD biomarker: T cell B-cell lymphoma 2 (Bcl-2) measured in blood over time
Timeframe: Baseline (Day 1) and up to 85 days
Interventions:
Enrollment:
54
Primary completion date:
2023-12-10
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Multiple Sclerosis, Colitis, Ulcerative
Product
Not applicable
Collaborators
Not applicable
Study date(s)
November 2021 to October 2023
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 Years
Accepts healthy volunteers
Yes
- 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.
- Prior medical history of anaphylaxis.
- Immunodeficiency or autoimmunity assessed by medical history.
Inclusion and exclusion 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.
Trial location(s)
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2023-12-10
Actual study completion date
2023-12-10
Plain language summaries
Summary of results in plain language
Available language(s): English
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
Additional information
Not applicable
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