Healthy Participants
Conditions
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.
Interventions
DRUGSTAR-0310
STAR-0310 will be administered as a subcutaneous bolus injection.
DRUGPlacebo
Placebo will be administered as a subcutaneous bolus injection.
Sponsors
Astria Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Experiencing Treatment-emergent Adverse Events | [Time Frame: Day 1 through Day 252] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Concentration of STAR-0310 | [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. |
| Number of Participants with Anti-drug Antibodies to STAR-0310 | [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. |
Countries
United States
Outcome results
None listed