Evaluation of the Safety, Tolerability and Pharmacokinetics (PK) of GSK3732394 First-Time-in-Human (FTIH) Study

Stopped early · Phase 1 · Has a placebo group

Conditions studied: HIV Infections

In brief

This is a phase 1, 2-part, double-blind (sponsor-unblinded), randomized, placebo-controlled, FTIH study, that includes both single-ascending and multiple-ascending dose phase to assess the safety, tolerability, and pharmacokinetic (PK)/pharmacodynamic (PD) attributes of GSK3732394 in healthy subjects. The data gathered in this study will further enable clinical development of GSK3732394 in HIV-infected subjects. Approximately 72 healthy subjects will be randomized in the FTIH study. Part 1 will be the single ascending dose (SAD) phase and Part 2 will be the multiple ascending dose (MAD) phase. Each subject in the SAD cohort will receive a single dose of blinded GSK3732394 or blinded placebo (PBO) in 6:2 ratio. Part 1 will consist of five ascending single-dose cohorts with an additional expansion cohort included as needed. Part 2 will consist of up to three ascending repeat-dose cohorts (MAD Cohorts 1, 2, and 3), randomized to four weekly doses of blinded GSK3732394 or blinded PBO in 6:2 ratio to be administered on Days 1, 8, 15, and 22.

Key facts

Study ID: NCT03984812
Run by: ViiV Healthcare
People needed: 24
Starts: 2019-06-17
Expected to finish: 2020-03-23
Last updated by the study team: 2021-10-25

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Subjects must be 18 to 50 years of age inclusive, at the time of signing the informed consent.
Subjects who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
Subjects who are able to understand and comply with protocol requirements and timetables, instructions, and protocol-stated restrictions
Body mass index within the range 19 to 30 kilogram per meter square (kg/m2) inclusive, in addition to a weight range of 50kg to 100kg.
Male and female healthy volunteers.
All male subjects must agree to use contraception during the treatment period and for at least 100 days after the last dose of study treatment and refrain from donating sperm during this period.
A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies; Not a woman of childbearing potential (WOCBP), A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 28 days prior to first dose, and 40 days after, the last dose of study treatment.
Capable of giving signed informed consent.
A signed and dated written informed consent must be completed prior to the subject's entry into the study.

You may not qualify if…

Subject has a history or presence of cardiovascular, dermatological, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, 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.
Subject has abnormal blood pressure (as determined by the investigator).
Subject had symptomatic herpes zoster within 3 months prior to screening.
Evidence of active or latent tuberculosis (TB) as documented by medical history and examination, TB testing that includes a positive tuberculin skin test [TST]; defined as a skin induration greater than 5 millimeter [mm] at 48 to 72 hours,and regardless of Bacillus Calmette-Guerin [BCG] or other vaccination history) or a positive (not indeterminate) QuantiFERON-TB Gold test.
Subjects with 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.
Subjects who had breast cancer within the past 10 years.
Subjects who had history of severe injection site reaction (i.e., required emergency care or hospitalization) following any prior injection, including reaction to vaccines.
Subjects with history of clinically significant allergy or prior hypersensitivity including those with a documented yeast allergy.
Subjects with history of, or current concern for, a chronic immune deficiency disorder including, but not limited to: diabetes, sickle cell anemia, and malnutrition.
Subjects having alanine transaminase (ALT) greater than 1.1 x upper limit of normal (ULN).
Subjects with Hemoglobin levels below the normal range.
Subjects with Platelet count <130,000 per cubic millimeters.
Subjects with Creatinine clearance (CrCL) <90 milliliters per minute.
Subjects with bilirubin greater than 1.1xULN (isolated bilirubin greater than 1.1xULN is acceptable if bilirubin is fractionated and direct bilirubin greater than 35%).
Subjects who has current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Subjects having Fridericia QT correction formula (QTcF) greater than 450 milliseconds (msec).
Subjects who had intended use of over-the-counter or prescription medication within 7 days prior to dosing.
Subjects who had live vaccine(s) within 1 month prior to screening, or plans to receive such vaccines during the study.
Subjects who had treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.
Subjects who had exposure to immune-modulating medications (including corticosteroids) within 30-days of Screening.
Subjects whose participation in the study would result in loss of blood or blood products in excess of 500 (milliliter) mL within 56 days.
Subjects who had Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
Subjects with current enrollment or past participation within the last 30 days before signing of consent in this or any other clinical study involving an investigational study intervention or any other type of medical research.
Absolute CD4+ T-cell count and CD4 percent (CD4%) outside of the normal range for the reference laboratory (to be confirmed at baseline, e.g., Day -1).
Subjects who had presence of Hepatitis B surface antigen (HBsAg) at screening.

Where it is running

GSK Investigational Site — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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