A First-time in Human (FTIH) Study to Evaluate Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK4528287 in Healthy Participants

NCT06681181 | Recruiting Phase 1

• 1 other identifier: 221603
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

"GSK4528287 is a drug being developed to treat like inflammatory bowel diseases like Crohns disease and ulcerative colitis. This study is the first time that GSK4528287 will be given to humans. The study will test single doses of GSK4528287 to check for side effects, measure blood levels, and understand how it works in the body. The study will start with a small dose, and the dose will be increased for each new group of participants."

Conditions

Colitis, Ulcerative

Keywords

Inflammatory bowel disease; Crohns disease; Ulcerative colitis; GSK4528287; First time in human (FTIH); Healthy participants; GlaxoSmithKline (GSK)

Outcome Measures

Primary Outcomes (6)

• Number of Participants with Adverse Events (AE)

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.

  Up to Day 351 (End of follow up period)

• Number of Participants with Serious Adverse Events (SAE)

  An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: Results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant.

  Up to Day 351 (End of follow up period)

• Number of Participants with Clinically Significant Changes in Laboratory Values

  Number of participants with clinically significant changes in laboratory values (hematology, chemistry, urinalysis, and virology) will be assessed.

  Up to Day 351 (End of follow up period)

• Number of Participants with Clinically Significant Changes in Vital Signs

  Number of participants with clinically significant changes in vital signs will be assessed.

  Up to Day 351 (End of follow up period)

• Number of Participants with Clinically Significant Changes in Telemetry

  Number of participants with clinically significant changes in telemetry will be assessed.

  On Day 1

• Number of Participants with Clinically Significant Changes in 12 lead Electrocardiogram (ECG)

  Number of participants with clinically significant changes in 12 lead ECG will be assessed.

  Up to Day 351 (End of follow up period)

Secondary Outcomes (7)

• Area under concentration-time curve (AUC) of GSK4528287

  Up to Day 337

• Maximum concentration (Cmax) of GSK4528287

  Up to Day 337

• Time to maximum concentration (Tmax) of GSK4528287

  Up to Day 337

• Apparent terminal phase half life (T-half) of GSK4528287

  Up to Day 337

• Clearance (CL) of GSK4528287

  Up to Day 337

Study Arms (7)

Cohort 1: Dose 1

EXPERIMENTAL

Participants will be administered Dose 1 of GSK4528287.

Drug: GSK4528287

Cohort 2: Dose 2

EXPERIMENTAL

Participants will be administered Dose 2 of GSK4528287.

Drug: GSK4528287

Cohort 3: Dose 3

EXPERIMENTAL

Participants will be administered Dose 3 of GSK4528287.

Drug: GSK4528287

Cohort 4: Dose 4

EXPERIMENTAL

Participants will be administered Dose 4 of GSK4528287.

Drug: GSK4528287

Cohort 5: Dose 5

EXPERIMENTAL

Participants will be administered Dose 5 of GSK4528287.

Drug: GSK4528287

Cohort 6: Dose 6

EXPERIMENTAL

Participants will be administered Dose 6 of GSK4528287.

Drug: GSK4528287

Placebo

PLACEBO COMPARATOR

Participants will receive Placebo.

Drug: Placebo

Interventions

GSK4528287 DRUG

GSK4528287 will be administered.

Cohort 1: Dose 1; Cohort 2: Dose 2; Cohort 3: Dose 3; Cohort 4: Dose 4; Cohort 5: Dose 5; Cohort 6: Dose 6

Placebo DRUG

Placebo will be administered.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
• White blood cell greater than or equal to (\>=) lower limit of normal (LLN), including both lymphocyte counts \>= LLN and neutrophil counts \>= LLN, at both screening and pre-dose (Day-1) Note: in cases where the test is abnormal, the participant may have the test repeated once and if their second test is normal, they will be eligible. In the event a second test is also abnormal, the participant is not eligible
• Electrocardiogram (ECG) with no clinically significant abnormality at the discretion of the investigator/designee
• Participants with a confirmed positive vaccination status for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines as per local/site guidance
• SARS-CoV-2 screening test negative as per local guidance
• If dosing is during influenza season (October to April per local guidelines), participants who have not had a seasonal influenza vaccine must receive a medicines and healthcare products regualtory agency (MHRA)-approved influenza vaccine at least 30 days before dosing
• Body weight \>= 50 kilograms (kg) and body mass index (BMI) within the range 18-32 kilograms per square meters (kg/m\^2) (inclusive)
• Male and/or female of non-childbearing potential
• Male participants are eligible to participate if they agree to the following during the study intervention period and for 48 weeks after the single dose of study intervention: refrain from donating sperm; be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; or agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant
• A female participant is eligible to participate if she is a woman of non-childbearing potential (WONCBP)
• Capable of giving signed informed consent

You may not qualify if:

• History or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data
• Abnormal blood pressure as determined by the investigator
• Symptomatic herpes zoster within 3 months prior to screening
• Prior medical history of anaphylaxis or severe adverse reactions to vaccines
• 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)
• Immunodeficiency or autoimmunity assessed by medical history.
• A history of recurrent infections
• Treatment of any significant 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, shingles)
• Any history of chronic infection including tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
• Any acute infection (including upper respriatory tract infection \[URTI\] and urinary tract infection \[UTI\]) 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 that, in the opinion of the investigator or GlaxoSmithKline (GSK) medical monitor, poses a safety risk with regards to participation in the trial
• History of malignancy, including malignant or non-malignant skin cancer
• Prior moderate/severe SARS-CoV-2 infection requiring oxygen supplementation or admission to hospital
• Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Cambridge, CB2 0GG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases; Crohn Disease

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The investigators will be blinded not knowing which study intervention each participant will be assigned to and this will be maintained throughout the course of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is single centre, double-blind study.

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 8, 2024
• Study Start: November 18, 2024
• Primary Completion: April 23, 2026
• Study Completion (Estimated): March 8, 2027
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

GB (1)