MedDataX Logo

A Study of STAR-0215 in Healthy Adult Participants

NCT ID: NCT05477160

Last Updated: 2024-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-27

Study Completion Date

2023-11-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Evaluate a Single Intravenous (IV) Dose Using a New Manufactured Clone and Single Ascending Doses of Subcutaneous (SC) Injections

NCT02150070

Pharmacokinetics of ASP2408 Healthy Subjects
COMPLETED PHASE1

A Study of STSA-1201 in Healthy Subjects

NCT05986877

Healthy
COMPLETED PHASE1

A First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD2373 After Single Dose Administration in Healthy Male Subjects of African Ancestry.

NCT04269031

Healthy Volunteers
COMPLETED PHASE1

A Study of STAR-0310 in Healthy Adult Participants

NCT06782477

Healthy Participants
ACTIVE_NOT_RECRUITING PHASE1

First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BCX7353 in Healthy Western and Japanese Volunteers

NCT02448264

Hereditary Angioedema
COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hereditary Angioedema

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

STAR-0215 Dose 1

Participants will be randomized to receive STAR-0215 or placebo.

Group Type EXPERIMENTAL

STAR-0215 (SC)

Intervention Type DRUG

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

Placebo (SC)

Intervention Type DRUG

Placebo will be administered as an SC bolus injection.

STAR-0215 Dose 2

Participants will be randomized to receive STAR-0215 or placebo.

Group Type EXPERIMENTAL

STAR-0215 (SC)

Intervention Type DRUG

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

Placebo (SC)

Intervention Type DRUG

Placebo will be administered as an SC bolus injection.

STAR-0215 Dose 3

Participants will be randomized to receive STAR-0215 or placebo.

Group Type EXPERIMENTAL

STAR-0215 (SC)

Intervention Type DRUG

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

Placebo (SC)

Intervention Type DRUG

Placebo will be administered as an SC bolus injection.

STAR-0215 Dose 4

Participants will be randomized to receive STAR-0215 or placebo.

Group Type EXPERIMENTAL

STAR-0215 (SC)

Intervention Type DRUG

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

Placebo (SC)

Intervention Type DRUG

Placebo will be administered as an SC bolus injection.

STAR-0215 Dose 5

Participants will be randomized to receive STAR-0215 or placebo.

Group Type EXPERIMENTAL

STAR-0215 (IV)

Intervention Type DRUG

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

Placebo (IV)

Intervention Type DRUG

Placebo will be administered as an IV bolus injection.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

STAR-0215 (SC)

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

Intervention Type DRUG

Placebo (SC)

Placebo will be administered as an SC bolus injection.

Intervention Type DRUG

STAR-0215 (IV)

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

Intervention Type DRUG

Placebo (IV)

Placebo will be administered as an IV bolus injection.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Astria Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Spaulding Clinical Research, LLC

West Bend, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Lumry W, Gunsior M, Cohen T, Bernard K, Gustafson P, Chung JK, Morabito C. Safety and pharmacokinetics of long-acting plasma kallikrein inhibitor navenibart (STAR-0215) in healthy adults. Ann Allergy Asthma Immunol. 2025 Jul;135(1):103-111.e2. doi: 10.1016/j.anai.2025.03.016. Epub 2025 Mar 28.

Reference Type DERIVED
PMID: 40158724 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STAR-0215-101

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study To Assess The Safety And Tolerability Of Increasing Single Doses Of ATR-107 (PF-05230900) In Healthy People
NCT01162889 TERMINATED PHASE1
A Study to Assess Safety, Tolerability, PK and PD of AZD2373 in Healthy Male Participants of Sub-Saharan West African Ancestry
NCT05351047 COMPLETED PHASE1
A Study to Evaluate the Safety of ASP2408 After Subcutaneous Administration to Healthy Male Subjects
NCT02140125 COMPLETED PHASE1
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-64232025 in Healthy Participants
NCT03550950 COMPLETED PHASE1
The Safety and Tolerability of STSA-1002 Following Intravenous Infusion in Healthy Subjects
NCT05032144 COMPLETED PHASE1
A Study to Evaluate How the Study Drug Moves Through the Body, Adverse Events, and How the Body Tolerates ABBV-547 Injections
NCT07232004 RECRUITING PHASE1
A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of ABBV-243 in Healthy Adults.
NCT07306754 RECRUITING PHASE1
A Study in Healthy Subjects to Assess the Safety, Tolerability and Pharmacokinetics of HTL0022562
NCT04941989 TERMINATED PHASE1
First-In-Human Study to Evaluate Single and Multiple Ascending Doses of JUV-161 in Healthy Adult Volunteers
NCT06918925 RECRUITING PHASE1
Phase 1 Single Ascending Doses (SAD) of M5542 in Healthy Participants
NCT06577337 RECRUITING PHASE1
A Study of AZD4205 in Healthy Adult Subjects
NCT03728023 COMPLETED PHASE1
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP6294 Administered Intravenously or Subcutaneously in Healthy Young Male and Female Subjects
NCT02681861 COMPLETED PHASE1
The Safety of STSA-1002 Following Intravenous Infusion in Healthy Subjects
NCT05166837 COMPLETED PHASE1
A Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP2408 Following Single Intravenous Doses in Healthy Subjects
NCT02125435 COMPLETED PHASE1
A Study to Assess ASP2713 in Healthy Subjects
NCT04017208 WITHDRAWN PHASE1
A Study of AST-008 in Healthy Subjects
NCT03086278 COMPLETED PHASE1
Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HSD-016
NCT00739232 COMPLETED PHASE1
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD5148 in Healthy Adults
NCT06469151 COMPLETED PHASE1
Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of MBX 2109 in Healthy Adult Subjects
NCT05158335 COMPLETED PHASE1
A Single Dose Study Of The Safety And Investigational Product Level Measurement In Healthy Subjects
NCT01284036 COMPLETED PHASE1
Hyaluronidase Assisted Subcutaneous Infusion
NCT06604546 COMPLETED PHASE3
A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-42847922 in Healthy Participants
NCT02230878 COMPLETED PHASE1
A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP015K in Healthy Subjects
NCT02141425 COMPLETED PHASE1
A First-in-human Study Looking at the Safety of ZP8396 and How it Works in the Body of Healthy Trial Participants
NCT05096598 COMPLETED PHASE1
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-42721458 in Healthy Male Participants
NCT01840501 COMPLETED PHASE1