Conditions: Hepatitis B
Keywords: Single dose Multiple ascending doses (MAD) Pharmacokinetics Safety GSK3389404 Tolerability
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 56
Healthy volunteers: yes

Brief summary:
This study is a Phase 1, randomized, double-blind (Sponsor unblinded), placebo controlled, dose escalation study to determine the safety, tolerability and pharmacokinetics (PK) profile of GSK3389404 as single (Part 1) and multiple subcutaneous (SC) injections (Part 2) in healthy subjects. This study represents the first administration of GSK3389404 in humans to define the safety, tolerability and PK following single and multiple doses of GSK3389404 in healthy subjects.

Detailed description:

Arms:
arm 1: Subjects will receive a single dose of GSK3389404 10 mg by subcutaneous injection on Day 1 of Part 1. arm 2: Subjects will receive a single dose of subcutaneous (injection under the skin) injection of placebo matching with GSK3389404 10 milligram (mg) or 30 mg, or 60 mg or 120 mg. arm 3: Subjects will receive a single dose of GSK3389404 30 mg by subcutaneous injection on Day 1 of Part 1. arm 4: Subjects will receive a single dose of GSK3389404 60 mg by subcutaneous injection on Day 1 of Part 1. arm 5: Subjects will receive a single dose of GSK3389404 120 mg by subcutaneous injection on Day 1 of Part 1. arm 6: Subjects will receive a single dose of GSK3389404 30 mg by subcutaneous injection QW for 4 weeks in Part 2. arm 7: Subjects will receive a single dose of subcutaneous injection of placebo matching with GSK3389404 30 mg or 60 mg or 120 mg once weekly (QW) for 4 weeks in Part 2. arm 8: Subjects will receive a single dose of GSK3389404 60 mg by subcutaneous injection QW for 4 weeks in Part 2. arm 9: Subjects will receive a single dose of GSK3389404 120 mg by subcutaneous injection QW for 4 weeks in Part 2.

Interventions: intervention 1: GSK3389404 intervention 2: Matching Placebo
Intervention descriptions: intervention 1: GSK3389404 is supplied as solution for injection vial. Each vial contains 100 mg/mL of GSK3389404. It's physical appearance is clear colourless to slightly yellow solution. intervention 2: Placebo is supplied as solution for injection vial. It's physical appearance is clear colourless solution.

Protocol document: