A Study of STAR-0310 in Healthy Adult Participants

NCT06782477 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: STAR-0310-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing Treatment-emergent Adverse Events

  [Time Frame: Day 1 through Day 252]

Secondary Outcomes (2)

• 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 ]

• Number of Participants with Anti-drug Antibodies to STAR-0310

  [Time Frame: Day 1 predose, Days 14, 28, 84, 168, 252 ]

Study Arms (5)

STAR-0310 Dose 1

EXPERIMENTAL

Participants will be randomized to receive STAR-0310 or matching placebo

Drug: STAR-0310; Drug: Placebo

STAR-0310 Dose 2

EXPERIMENTAL

Participants will be randomized to receive STAR-0310 or matching placebo

Drug: STAR-0310; Drug: Placebo

STAR-0310 Dose 3

EXPERIMENTAL

Participants will be randomized to receive STAR-0310 or matching placebo

Drug: STAR-0310; Drug: Placebo

STAR-0310 Dose 4

EXPERIMENTAL

Participants will be randomized to receive STAR-0310 or matching placebo

Drug: STAR-0310; Drug: Placebo

STAR-0310 in Participants of Japanese Descent

EXPERIMENTAL

Participants will be randomized to receive STAR-0310 or matching placebo

Drug: STAR-0310; Drug: Placebo

Interventions

STAR-0310 DRUG

STAR-0310 will be administered as a subcutaneous bolus injection.

STAR-0310 Dose 1; STAR-0310 Dose 2; STAR-0310 Dose 3; STAR-0310 Dose 4; STAR-0310 in Participants of Japanese Descent

Placebo DRUG

Placebo will be administered as a subcutaneous bolus injection.

STAR-0310 Dose 1; STAR-0310 Dose 2; STAR-0310 Dose 3; STAR-0310 Dose 4; STAR-0310 in Participants of Japanese Descent

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Astria Therapeutics, Inc.: lead

Study Sites (1)

Austin Clinical Research Unit - Early Clinical Development

Austin, Texas, 78744, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 20, 2025
• Study Start: January 7, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: November 4, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)