A Study of STAR-0215 in Healthy Adult Participants

• ClinicalTrials.gov Identifier: NCT05477160
• Recruitment Status: Completed
• First Posted: July 28, 2022
• Last Update Posted: January 11, 2024
• Sponsor: Astria Therapeutics, Inc.
• Information provided by (Responsible Party): Astria Therapeutics, Inc.

Tracking Information

• First Submitted Date: July 26, 2022
• First Posted Date: July 28, 2022
• Last Update Posted Date: January 11, 2024
• Actual Study Start Date: July 27, 2022
• Actual Primary Completion Date: November 17, 2023 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 26, 2022): Number of Participants Experiencing Treatment-emergent Adverse Events [ Time Frame: Day 1 through Day 224 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 26, 2022)

• Serum Concentration of STAR-0215 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of STAR-0215 in Healthy Adult Participants
• 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Hereditary Angioedema

Intervention

• 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.
• 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.

Study Arms

• Experimental: STAR-0215 Dose 1
  Participants will be randomized to receive STAR-0215 or placebo.
  Interventions:

  • Drug: STAR-0215 (SC)
  • Drug: Placebo (SC)
• Experimental: STAR-0215 Dose 2
  Participants will be randomized to receive STAR-0215 or placebo.
  Interventions:

  • Drug: STAR-0215 (SC)
  • Drug: Placebo (SC)
• Experimental: STAR-0215 Dose 3
  Participants will be randomized to receive STAR-0215 or placebo.
  Interventions:

  • Drug: STAR-0215 (SC)
  • Drug: Placebo (SC)
• Experimental: STAR-0215 Dose 4
  Participants will be randomized to receive STAR-0215 or placebo.
  Interventions:

  • Drug: STAR-0215 (SC)
  • Drug: Placebo (SC)
• Experimental: STAR-0215 Dose 5
  Participants will be randomized to receive STAR-0215 or placebo.
  Interventions:

  • Drug: STAR-0215 (IV)
  • Drug: Placebo (IV)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 23, 2023): 41
• Original Estimated Enrollment (submitted: July 26, 2022): 24
• Actual Study Completion Date: November 17, 2023
• Actual Primary Completion Date: November 17, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05477160
• Other Study ID Numbers: STAR-0215-101
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Astria Therapeutics, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Astria Therapeutics, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Astria Therapeutics, Inc.
• Verification Date: January 2024