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OpenTrials
Completed

NCT Number: NCT05477160

A Study of STAR-0215 in Healthy Adult Participants

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

STAR-0215 (SC)

Drug

STAR-0215 will be administered as an SC bolus injection.

Placebo (SC)

Drug

Placebo will be administered as an SC bolus injection.

STAR-0215 (IV)

Drug

STAR-0215 will be administered as an IV bolus injection.

Placebo (IV)

Drug

Placebo will be administered as an IV bolus injection.

Primary outcomes

  1. Number of Participants Experiencing Treatment-emergent Adverse Events

    Time frame: Day 1 through Day 224

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Astria Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 28, 2022
Registry last updated
Jan 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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