A Study of STAR-0215 in Healthy Adult Participants

Hereditary Angioedema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05477160
• Other study ID #: STAR-0215-101
• Status: Completed
• Phase: Phase 1
• Start date: July 27, 2022
• Est. completion date: November 17, 2023

Study information

• Verified date: January 2024
• Source: Astria Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 17, 2023
• Est. primary completion date: November 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Angioedema
• Hereditary Angioedema

Intervention

Drug:
• STAR-0215 (SC)
STAR-0215 will be administered as an SC bolus injection.
• Placebo (SC)
Placebo will be administered as an SC bolus injection.
• STAR-0215 (IV)
STAR-0215 will be administered as an IV bolus injection.
• Placebo (IV)
Placebo will be administered as an IV bolus injection.

Locations

Country	Name	City	State
United States	Spaulding Clinical Research, LLC	West Bend	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Astria Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Experiencing Treatment-emergent Adverse Events		Day 1 through Day 224
Secondary	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
Secondary	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
Secondary	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