A Study of STAR-0215 in Healthy Adult Participants

A First-in-Human, Phase 1a, Randomized, Double-Blind, Placebo Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of STAR-0215 in Healthy Adult Subjects

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.

Study Overview

• Status: Completed
• Conditions: Hereditary Angioedema
• Intervention / Treatment: Drug: STAR-0215 (SC); Drug: Placebo (SC); Drug: STAR-0215 (IV); Drug: Placebo (IV)

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • West Bend, Wisconsin, United States, 53095
      • Spaulding Clinical Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STAR-0215 Dose 1; Participants will be randomized to receive STAR-0215 or placebo.	Drug: STAR-0215 (SC); STAR-0215 will be administered as an SC bolus injection.; Drug: Placebo (SC); Placebo will be administered as an SC bolus injection.
Experimental: STAR-0215 Dose 2; Participants will be randomized to receive STAR-0215 or placebo.	Drug: STAR-0215 (SC); STAR-0215 will be administered as an SC bolus injection.; Drug: Placebo (SC); Placebo will be administered as an SC bolus injection.
Experimental: STAR-0215 Dose 3; Participants will be randomized to receive STAR-0215 or placebo.	Drug: STAR-0215 (SC); STAR-0215 will be administered as an SC bolus injection.; Drug: Placebo (SC); Placebo will be administered as an SC bolus injection.
Experimental: STAR-0215 Dose 4; Participants will be randomized to receive STAR-0215 or placebo.	Drug: STAR-0215 (SC); STAR-0215 will be administered as an SC bolus injection.; Drug: Placebo (SC); Placebo will be administered as an SC bolus injection.
Experimental: STAR-0215 Dose 5; Participants will be randomized to receive STAR-0215 or placebo.	Drug: STAR-0215 (IV); STAR-0215 will be administered as an IV bolus injection.; Drug: Placebo (IV); Placebo will be administered as an IV bolus injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants Experiencing Treatment-emergent Adverse Events	Day 1 through Day 224

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Astria Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2022
• Primary Completion (Actual): November 17, 2023
• Study Completion (Actual): November 17, 2023

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: HAE; Angioedema
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Vascular; Hypersensitivity; Urticaria; Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Angioedema; Angioedemas, Hereditary
• Other Study ID Numbers: STAR-0215-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No