Last updated: 08/24/2026 07:00:49
A Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Two GSK3862995B Formulations in Healthy Participants
GSK study ID
301202
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Not yet recruiting
Not yet recruiting
Trial overview
Official title: A Phase 1, Open-Label, Randomized, Parallel-Group Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Two GSK3862995B Formulations After a Single Dose in Healthy Participants
Trial description: This study will compare two formulations of the investigational medicine GSK3862995B in healthy adults. The study aims to assess how the body absorbs and processes the medicine, and to evaluate its safety and tolerability.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Area Under the Serum Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-t)] of GSK3862995B
Timeframe: From pre-dose on Day 1 through Week 36
Maximum Observed Serum Concentration (Cmax) of GSK3862995B
Timeframe: From pre-dose on Day 1 through Week 36
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: Up to Week 49
Number of Participants With Clinically Significant Changes in Laboratory Parameters, Vital Signs, and 12-Lead Electrocardiogram (ECG) Findings
Timeframe: Up to Week 36
Secondary outcomes:
Not applicable
Interventions:
Drug: GSK3862995B
Enrollment:
24
Observational study model:
Not applicable
Primary completion date:
2027-07-09
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
Not applicable
Collaborators
Not applicable
Study date(s)
August 2026 to September 2027
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 Years
Accepts healthy volunteers
Yes
- Participants who are generally healthy as determined by medical evaluation including medical history, physical examination laboratory tests, and cardiac monitoring
- Body weight of at least 50.0 kilogram (kg) for male participants or at least 45.0 kg for female participants
- Participant has a past or current medical condition(s) or disease(s) that is/are not well controlled and, which in the judgement of the Investigator, may affect participant safety or affect study endpoints.
- A history of recurrent infections, or treatment of a chronic infection within 3 months prior to the first dose of study drug, including both serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, tuberculosis, hepatitis B or C, shingles) or non-respiratory acute infections that required antimicrobial treatment within 4 weeks before screening
Inclusion and exclusion criteria
Inclusion criteria:
- Participants who are generally healthy as determined by medical evaluation including medical history, physical examination laboratory tests, and cardiac monitoring
- Body weight of at least 50.0 kilogram (kg) for male participants or at least 45.0 kg for female participants
- Body Mass Index (BMI) within the range of 18.0 to 32.0 kilogram per square meter (kg/m^2) (inclusive)
- Male, or female of non-childbearing potential (PONCBP)
Exclusion criteria:
- Participant has a past or current medical condition(s) or disease(s) that is/are not well controlled and, which in the judgement of the Investigator, may affect participant safety or affect study endpoints.
- A history of recurrent infections, or treatment of a chronic infection within 3 months prior to the first dose of study drug, including both serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, tuberculosis, hepatitis B or C, shingles) or non-respiratory acute infections that required antimicrobial treatment within 4 weeks before screening
- Abnormal blood pressure (as determined by the investigator)
- Symptomatic herpes zoster within 3 months prior to screening
- Significant allergies to humanized monoclonal antibodies
- Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A (IgA) dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis)
- Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
- Breast cancer within the past 10 years
- Alanine transaminase (ALT) greater than (>)1.0x upper limit of normal (ULN)
- Total bilirubin >1.5 x ULN; Participants with Gilbert’s syndrome can be included with total bilirubin >1.5 x ULN as long as direct bilirubin is less than or equal to (<=) 1.5 x ULN
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones) o A clinically significant abnormality in the average of triplicate 12-lead ECG readings performed at screening
Trial location(s)
Location
GSK Investigational Site
Cambridge, United Kingdom, CB2 2GG
Status
Will Be Recruiting
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Not yet recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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