A Study of STAR-0215 in Healthy Adult Participants
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
1 other identifier
interventional
41
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2022
CompletedStudy Start
First participant enrolled
July 27, 2022
CompletedFirst Posted
Study publicly available on registry
July 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 17, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 17, 2023
CompletedJanuary 11, 2024
January 1, 2024
1.3 years
July 26, 2022
January 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Experiencing Treatment-emergent Adverse Events
Day 1 through Day 224
Secondary Outcomes (3)
Serum Concentration of STAR-0215
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
Plasma Levels of Cleaved High-molecular-weight Kininogen
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
Number of Participants with Anti-drug Antibodies to STAR-0215
Day 1 (pre-dose, up to 2 hours before study drug administration); Days 28, 56, 84, 112, 140, 168, 196, and 224
Study Arms (5)
STAR-0215 Dose 1
EXPERIMENTALParticipants will be randomized to receive STAR-0215 or placebo.
STAR-0215 Dose 2
EXPERIMENTALParticipants will be randomized to receive STAR-0215 or placebo.
STAR-0215 Dose 3
EXPERIMENTALParticipants will be randomized to receive STAR-0215 or placebo.
STAR-0215 Dose 4
EXPERIMENTALParticipants will be randomized to receive STAR-0215 or placebo.
STAR-0215 Dose 5
EXPERIMENTALParticipants will be randomized to receive STAR-0215 or placebo.
Interventions
STAR-0215 will be administered as an SC bolus injection.
Placebo will be administered as an SC bolus injection.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Spaulding Clinical Research, LLC
West Bend, Wisconsin, 53095, United States
Related Publications (1)
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.
PMID: 40158724DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2022
First Posted
July 28, 2022
Study Start
July 27, 2022
Primary Completion
November 17, 2023
Study Completion
November 17, 2023
Last Updated
January 11, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share