A Study of STAR-0215 in Healthy Adult Participants
Primary Purpose
Hereditary Angioedema
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
STAR-0215 (SC)
Placebo (SC)
STAR-0215 (IV)
Placebo (IV)
Sponsored by
About this trial
This is an interventional treatment trial for Hereditary Angioedema focused on measuring HAE, Angioedema
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.
Sites / Locations
- Spaulding Clinical Research, LLC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
STAR-0215 Dose 1
STAR-0215 Dose 2
STAR-0215 Dose 3
STAR-0215 Dose 4
STAR-0215 Dose 5
Arm Description
Participants will be randomized to receive STAR-0215 or placebo.
Participants will be randomized to receive STAR-0215 or placebo.
Participants will be randomized to receive STAR-0215 or placebo.
Participants will be randomized to receive STAR-0215 or placebo.
Participants will be randomized to receive STAR-0215 or placebo.
Outcomes
Primary Outcome Measures
Number of Participants Experiencing Treatment-emergent Adverse Events
Secondary Outcome Measures
Serum Concentration of STAR-0215
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
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
Blood samples will be collected to assess the formation of STAR-0215 anti-drug antibodies in serum before and after study drug administration.
Full Information
NCT ID
NCT05477160
First Posted
July 26, 2022
Last Updated
August 23, 2023
Sponsor
Astria Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05477160
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 27, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astria Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hereditary Angioedema
Keywords
HAE, Angioedema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
STAR-0215 Dose 1
Arm Type
Experimental
Arm Description
Participants will be randomized to receive STAR-0215 or placebo.
Arm Title
STAR-0215 Dose 2
Arm Type
Experimental
Arm Description
Participants will be randomized to receive STAR-0215 or placebo.
Arm Title
STAR-0215 Dose 3
Arm Type
Experimental
Arm Description
Participants will be randomized to receive STAR-0215 or placebo.
Arm Title
STAR-0215 Dose 4
Arm Type
Experimental
Arm Description
Participants will be randomized to receive STAR-0215 or placebo.
Arm Title
STAR-0215 Dose 5
Arm Type
Experimental
Arm Description
Participants will be randomized to receive STAR-0215 or placebo.
Intervention Type
Drug
Intervention Name(s)
STAR-0215 (SC)
Intervention Description
STAR-0215 will be administered as an SC bolus injection.
Intervention Type
Drug
Intervention Name(s)
Placebo (SC)
Intervention Description
Placebo will be administered as an SC bolus injection.
Intervention Type
Drug
Intervention Name(s)
STAR-0215 (IV)
Intervention Description
STAR-0215 will be administered as an IV bolus injection.
Intervention Type
Drug
Intervention Name(s)
Placebo (IV)
Intervention Description
Placebo will be administered as an IV bolus injection.
Primary Outcome Measure Information:
Title
Number of Participants Experiencing Treatment-emergent Adverse Events
Time Frame
Day 1 through Day 224
Secondary Outcome Measure Information:
Title
Serum Concentration of STAR-0215
Description
Blood samples will be collected to measure the serum concentration of STAR-0215 before and after study drug administration.
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
Title
Plasma Levels of Cleaved High-molecular-weight Kininogen
Description
Blood samples will be collected to measure the plasma levels of cleaved high-molecular-weight kininogen (a measure of plasma kallikrein activity).
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
Title
Number of Participants with Anti-drug Antibodies to STAR-0215
Description
Blood samples will be collected to assess the formation of STAR-0215 anti-drug antibodies in serum before and after study drug administration.
Time Frame
Day 1 (pre-dose, up to 2 hours before study drug administration); Days 28, 56, 84, 112, 140, 168, 196, and 224
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Spaulding Clinical Research, LLC
City
West Bend
State/Province
Wisconsin
ZIP/Postal Code
53095
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of STAR-0215 in Healthy Adult Participants
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