Austin Clinical Research Unit - Early Clinical Development
Austin, Texas, 78744, United States
NCT Number: NCT06782477
This is a randomized, double-blind, placebo-controlled, single ascending dose trial evaluating the safety, tolerability, PK, and immunogenicity of STAR-0310 in healthy adult participants. There are 4 planned cohorts and potentially up to 1 additional cohort which may comprise of healthy adult participants of Japanese descent.
This study is active but is not currently recruiting participants.
Notify Me18 year–60 year
All sexes
Interventional
Phase 1
Austin, Texas, 78744, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
STAR-0310 will be administered as a subcutaneous bolus injection.
Placebo will be administered as a subcutaneous bolus injection.
Time frame: [Time Frame: Day 1 through Day 252]
Time frame: [Time Frame: Day 1 (predose up to 2 hours before study drug administration, and 12 hours post dose), Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 84, 112, 140, 168, 196, 224, 252 ]
Blood samples will be collected to measure the serum concentration of STAR-0310 before and after study drug administration.
Time frame: [Time Frame: Day 1 predose, Days 14, 28, 84, 168, 252 ]
Blood samples will be collected to assess the formation of STAR-0310 anti-drug antibodies in serum before and after study drug administration.
Astria Therapeutics, Inc.
Industry
A First-in-Human, Phase 1a, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, Single Ascending Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of STAR-0310 in Healthy Adult Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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