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A Study of STAR-0215 in Healthy Adult Participants

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ClinicalTrials.gov Identifier: NCT05477160
Recruitment Status : Active, not recruiting
First Posted : July 28, 2022
Last Update Posted : August 24, 2023
Sponsor:
Information provided by (Responsible Party):
Astria Therapeutics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hereditary Angioedema Drug: STAR-0215 (SC) Drug: Placebo (SC) Drug: STAR-0215 (IV) Drug: Placebo (IV) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : July 27, 2022
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2023

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants Experiencing Treatment-emergent Adverse Events [ Time Frame: Day 1 through Day 224 ]

Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05477160


Locations
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United States, Wisconsin
Spaulding Clinical Research, LLC
West Bend, Wisconsin, United States, 53095
Sponsors and Collaborators
Astria Therapeutics, Inc.
More Information
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Responsible Party: Astria Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05477160    
Other Study ID Numbers: STAR-0215-101
First Posted: July 28, 2022    Key Record Dates
Last Update Posted: August 24, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Astria Therapeutics, Inc.:
HAE
Angioedema
Additional relevant MeSH terms:
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Angioedema
Angioedemas, Hereditary
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
 Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Hereditary Complement Deficiency Diseases
Primary Immunodeficiency Diseases
Genetic Diseases, Inborn
Immunologic Deficiency Syndromes