A Study of STAR-0215 in Healthy Adult Participants
NCT05477160 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41
Last updated 2024-01-11
Summary
This is a first-in-human, single-center, randomized, double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single subcutaneous (SC) or intravenous (IV) administration of STAR-0215 in healthy adult participants.
Conditions
Interventions
- DRUG
-
STAR-0215 (SC)
STAR-0215 will be administered as an SC bolus injection.
- DRUG
-
Placebo (SC)
Placebo will be administered as an SC bolus injection.
- DRUG
-
STAR-0215 (IV)
STAR-0215 will be administered as an IV bolus injection.
- DRUG
-
Placebo (IV)
Placebo will be administered as an IV bolus injection.
Sponsors & Collaborators
-
Astria Therapeutics, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-07-27
- Primary Completion
- 2023-11-17
- Completion
- 2023-11-17
- FDA Drug
- Yes
Countries
- United States
Study Locations
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