A Study of STAR-0215 in Healthy Adult Participants

Phase 1

Completed

• Conditions: Hereditary Angioedema
• Interventions: Drug: STAR-0215 (IV); Drug: STAR-0215 (SC); Drug: Placebo (IV); Drug: Placebo (SC)

• Registration Number: NCT05477160
• Lead Sponsor: Astria Therapeutics, Inc.

Brief Summary

This is a first-in-human, single-center, randomized, double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single subcutaneous (SC) or intravenous (IV) administration of STAR-0215 in healthy adult participants.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-26
• Study First Submitted QC: 2022-07-26
• Study Start: 2022-07-27
• Study First Posted: 2022-07-28
• Primary Completion: 2023-11-17
• Study Completion: 2023-11-17
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Good health as determined by the Investigator based upon a medical evaluation, including medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory measurements. Assessments may be repeated per Investigator discretion.
• Body mass index of 18 to 35 kilograms (kg)/square meter 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.
• Female participants capable of becoming pregnant must have a negative serum pregnancy test at Screening, not be nursing, and must agree to use an effective method of contraception and abstain from egg donation or fertility treatment.
• Male participants must agree to use an effective method of contraception and abstain from sperm donation.

Exclusion Criteria

• Prior or ongoing medical condition (for example, gastrointestinal, renal, hepatic, dermatological, neurological or psychiatric, cardiovascular, respiratory, or hematological), medical history, physical examination, vital signs, ECG, or clinical laboratory abnormality that, in the Investigator's opinion, could adversely affect the safety of the participant. Assessments may be repeated once prior to dosing as needed per Investigator discretion.
• Known sensitivity to the ingredients in STAR-0215.
• Regular use of prescription or non-prescription drugs unless Investigator believes the medication(s) will not interfere with the study or compromise participant safety.
• Participation in a recent clinical study involving receipt of an investigational product within 30 days prior to the first dose of study drug or exposure to more than 4 investigational products within 12 months prior to the first dose of study drug.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STAR-0215 Dose 5	STAR-0215 (IV)	Participants will be randomized to receive STAR-0215 or placebo.
STAR-0215 Dose 5	Placebo (IV)	Participants will be randomized to receive STAR-0215 or placebo.
STAR-0215 Dose 4	Placebo (SC)	Participants will be randomized to receive STAR-0215 or placebo.
STAR-0215 Dose 1	STAR-0215 (SC)	Participants will be randomized to receive STAR-0215 or placebo.
STAR-0215 Dose 1	Placebo (SC)	Participants will be randomized to receive STAR-0215 or placebo.
STAR-0215 Dose 2	STAR-0215 (SC)	Participants will be randomized to receive STAR-0215 or placebo.
STAR-0215 Dose 2	Placebo (SC)	Participants will be randomized to receive STAR-0215 or placebo.
STAR-0215 Dose 3	STAR-0215 (SC)	Participants will be randomized to receive STAR-0215 or placebo.
STAR-0215 Dose 3	Placebo (SC)	Participants will be randomized to receive STAR-0215 or placebo.
STAR-0215 Dose 4	STAR-0215 (SC)	Participants will be randomized to receive STAR-0215 or placebo.

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Treatment-emergent Adverse Events	Day 1 through Day 224

Secondary Outcome Measures

Name	Time	Method
Serum Concentration of STAR-0215	Day 1 (pre-dose, up to 2 hours before study drug administration, and 2, 6, 12, 24, 48, 72, 96, and 120 hours post-dose); Days 14, 28, 56, 84, 112, 140, 168, 196, and 224	Blood samples will be collected to measure the serum concentration of STAR-0215 before and after study drug administration.
Plasma Levels of Cleaved High-molecular-weight Kininogen	Day 1 (pre-dose, up to 2 hours before study drug administration, and 2, 6, 12, 24, 48, 72, 96, and 120 hours post-dose); Days 14, 28, 56, 84, 112, 140, 168, 196, and 224	Blood samples will be collected to measure the plasma levels of cleaved high-molecular-weight kininogen (a measure of plasma kallikrein activity).
Number of Participants with Anti-drug Antibodies to STAR-0215	Day 1 (pre-dose, up to 2 hours before study drug administration); Days 28, 56, 84, 112, 140, 168, 196, and 224	Blood samples will be collected to assess the formation of STAR-0215 anti-drug antibodies in serum before and after study drug administration.

Trial Locations

Locations (1)

Spaulding Clinical Research, LLC; 🇺🇸 West Bend, Wisconsin, United States