Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Phase 1, First-in-Human Trial of BLN-481in Healthy Adult Participants
Sponsor: Beeline Medicines Corporation
Summary
This Phase 1 first-in-human study will evaluate BLN-481 in healthy adults. Participants will receive BLN-481 or placebo. Part 1 evaluates single ascending intravenous (IV) doses (SAD) and optional subcutaneous (SC) doses. Part 2 evaluates multiple ascending subcutaneous doses (MAD). The main purpose is to assess safety and tolerability. The study will also evaluate how BLN-481 moves through the body, whether anti-drug antibodies (ANA) develop, and pharmacodynamic (PD) effects.
Official title: A Phase 1, Randomized, Multi-Part, First-in-Human Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of BLN-481 in Healthy Adult Participants
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
104
Start Date
2026-10-12
Completion Date
2027-11-24
Last Updated
2026-10-29
Healthy Volunteers
Yes
Interventions
Placebo
Matching placebo is administered by the same route and on the same schedule as the assigned BLN-481 cohort. Part 1 placebo is administered as a single IV infusion or SC injection. Part 2 placebo is administered SC Q2W or Q4W for 3 total doses. Each cohort uses blinded sentinel dosing: 1 participant assigned to BLN-481 and 1 participant assigned to placebo are dosed first before the remaining cohort participants.
BLN-481
Part 1 (SAD): Single IV doses in Cohorts 1A-1E at planned doses of 10, 30, 100, 300, and 900 mg. Optional Cohort 1X may receive a single IV or SC dose; optional Cohorts 1Y and 1Z may receive a single SC dose, with dose levels to be determined. Each Part 1 cohort includes up to 8 participants randomized 6:2 to BLN-481: placebo. Part 2 (MAD): SC dosing in Cohort 2A at 50 mg Q2W, Cohort 2B at 150 mg Q2W, and Cohort 2C at 450 mg Q2W or Q4W, for 3 total doses. Optional Cohort 2D may receive a dose to be determined Q2W or Q4W for 3 total doses. Each Part 2 cohort includes up to 10 participants randomized 8:2 to BLN-481: placebo.