A Phase 1, Randomized, Double-Blind, Placebo Controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK4528287 in Healthy Participants

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
United Kingdom
GSK Investigational Site
RECRUITING
Cambridge
Contact Information
Primary
US GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
877-379-3718
Backup
EU GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466
Time Frame
Start Date: 2024-11-18
Estimated Completion Date: 2027-03-08
Participants
Target number of participants: 48
Treatments
Experimental: Cohort 1: Dose 1
Participants will be administered Dose 1 of GSK4528287.
Experimental: Cohort 2: Dose 2
Participants will be administered Dose 2 of GSK4528287.
Experimental: Cohort 3: Dose 3
Participants will be administered Dose 3 of GSK4528287.
Experimental: Cohort 4: Dose 4
Participants will be administered Dose 4 of GSK4528287.
Experimental: Cohort 5: Dose 5
Participants will be administered Dose 5 of GSK4528287.
Experimental: Cohort 6: Dose 6
Participants will be administered Dose 6 of GSK4528287.
Placebo_comparator: Placebo
Participants will receive Placebo.
Sponsors
Leads: GlaxoSmithKline

This content was sourced from clinicaltrials.gov

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