A Study of STAR-0310 in Healthy Adult Participants

Astria Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Placebo; Drug: STAR-0310

Study type: Interventional

Funder types: Industry

Identifiers

NCT06782477

STAR-0310-101

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

40 participants in 5 patient groups

STAR-0310 Dose 1

Experimental group

Description:

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

Treatment:

Drug: STAR-0310

Drug: Placebo

STAR-0310 Dose 2

Experimental group

Description:

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

Treatment:

Drug: STAR-0310

Drug: Placebo

STAR-0310 Dose 3

Experimental group

Description:

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

Treatment:

Drug: STAR-0310

Drug: Placebo

STAR-0310 Dose 4

Experimental group

Description:

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

Treatment:

Drug: STAR-0310

Drug: Placebo

STAR-0310 in Participants of Japanese Descent

Experimental group

Description:

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

Treatment:

Drug: STAR-0310

Drug: Placebo