Clinical trial NCT06782477: A Study of STAR-0310 in Healthy Adult Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Astria Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2025-01-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Good health as determined by the Investigator based upon a medical evaluation.
* Body mass index (BMI) of 18 to 35 kg/m2 with a weight of at least 60 kg for men and at least 50 kg for women, with a maximum weight of 130 kg for any participant.
* Participants of childbearing potential must have a negative serum pregnancy test at Screening, agree to use highly effective forms of contraception and abstain from egg donation or fertility treatment
* Participants capable of producing sperm must use an effective method of contraception and abstain from sperm donation
* Healthy adults of Japanese descent, where both biological parents and all 4 biological grandparents are of Japanese ethnicity (applicable only for potential cohort of participants of Japanese descent).

Exclusion Criteria:

* Prior or ongoing medical condition that, in the Investigator's opinion, could adversely affect the safety of the participant.
* Known sensitivity to the ingredients of STAR-0310
* Taking any prescription or non-prescription medications within at least 5 half-lives or 7 days, whichever is longer, before the time of admission
* History of exposure to any biologic medication within 90 days or 5 half-lives, whichever is longer, before the time of admission
* Participation in a clinical trial involving receipt of an investigational product within 30 days (small molecule) or 90 days (biologics), or 5 half-lives, whichever is longer, before the time of admission

Primary outcomes:
measure: Number of Participants Experiencing Treatment-emergent Adverse Events
timeFrame: [Time Frame: Day 1 through Day 252]
Secondary outcomes:
measure: Serum Concentration of STAR-0310
timeFrame: [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 ]
measure: Number of Participants with Anti-drug Antibodies to STAR-0310
timeFrame: [Time Frame: Day 1 predose, Days 14, 28, 84, 168, 252 ]
Other outcomes:
Locations:
city: Austin
country: United States
facility: Austin Clinical Research Unit - Early Clinical Development
state: Texas
Study officials:
References: