A Trial to Compare the Pharmacokinetics of Two Presentations of Navenibart in Healthy Participants
- Summary
- The goal of this clinical trial is to compare two different presentations (vial and syringe versus autoinjector) of navenibart in healthy adult volunteers. The main questions it aims to answer are: * Do these presentations lead to similar drug concentrations in the blood? * Do these presentations lead to similar safety and tolerability? Researchers will compare the drug concentrations and safety profile of each group to determine if they are similar. Participants will: * Receive one dose of navenibart with either the vial and syringe or the autoinjector. * Stay in the clinic beginning one day prior to dosing through 2 days after dosing. * Return to the clinic for approximately 9 additional non-residential visits. * Complete medical and other testing, including blood draws.
- Short title
- A Trial to Compare the Pharmacokinetics of Two Presentations of Navenibart in Healthy Participants
- Official title
- A Phase 1, Randomized, Open-Label, Parallel-Group Trial Comparing the Pharmacokinetics of Navenibart Administered by Vial/Syringe Versus Autoinjector in Healthy Adult Volunteers
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2026-12-01
- First posted
- 2026-06-09
- Registry last updated
- 2026-06-09
- Primary completion date
- 2026-09-01
- Start date
- 2026-04-21
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Astria Therapeutics, Inc.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07635095
- ClinicalTrials.gov ID
- NCT07635095
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Other
- Masking
- No masking
Maximum concentration (Cmax) following a single dose of subcutaneous navenibart
Timeframe: Up to 84 days post dose
Plasma concentrations are assessed via a validated method and used to estimate PK parameters via noncompartmental analysis.
Area under the concentration versus time curve from time 0 to 84 days (AUC0-84d) following a single dose of subcutaneous navenibart
Timeframe: Up to 84 days post dose
Plasma concentrations are assessed via a validated method and used to estimate PK parameters via noncompartmental analysis.
Time to reach maximum plasma concentration (Tmax) following a single dose of subcutaneous navenibart
Timeframe: Up to 140 days post dose
Plasma concentrations are assessed via a validated method and used to estimate PK parameters via noncompartmental analysis.
Apparent clearance (CL/F) following a single dose of subcutaneous navenibart
Timeframe: Up to 140 days post dose
Plasma concentrations are assessed via a validated method and used to estimate PK parameters via noncompartmental analysis.
Apparent volume of distribution during the terminal phase (Vz/F) following a single subcutaneous dose of navenibart
Timeframe: Up to 140 days post dose
Plasma concentrations are assessed via a validated method and used to estimate PK parameters via noncompartmental analysis.
Terminal half-life (t1/2) following a single subcutaneous dose of navenibart
Timeframe: Up to 140 days post dose
Plasma concentrations are assessed via a validated method and used to estimate PK parameters via noncompartmental analysis.
Incidence of treatment-emergent adverse events (TEAEs), including severity and relationship to navenibart following a single subcutaneous dose of navenibart
Timeframe: Up to 168 days post dose
Adverse events (AEs) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), Version 28.0 or higher. All AEs will be assigned a severity grade using CTCAE Version 6.0 or higher. Relationship to navenibart will be assessed by the investigator.
Incidence and magnitude of treatment-emergent anti-drug antibodies (ADA)
Timeframe: Up to 140 days post dose
ADA will be assessed via a validated bioanalytical method. Incidence will be assessed as proportion of participants with a treatment-emergent ADA. Magnitude of ADA response will be assessed via titers for confirmed ADA-positive samples.
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 55 Years
- Healthy volunteers
- Yes
Key Inclusion Criteria:
- Males and females 18 to 55 years of age
- In good health, as determined by the Investigator
- Written informed consent, including confirmation of willingness to comply with all trial procedures
- Body weight between 50 and 100 kg, and body mass index (BMI) between 18 and 30 kg/m^2
- Has not previously received navenibart
- Not pregnant or breastfeeding and agreement to comply with requirements for pregnancy and breastfeeding, contraception use, and egg donation for the specified periods.
Key Exclusion Criteria:
- Prior or ongoing medical history, or results of a medical assessment, that the Investigator feels could result in a risk to the safety of the participant or the quality of data from the trial.
- Key laboratory results outside of defined ranges
- History or positive test results for tobacco, nicotine products, alcohol, marijuana (cannabis), or drugs of abuse
- Receipt of other prohibited medications, biologic medications, or investigational products within defined windows prior to dosing
- History of severe allergic reactions with an unknown cause
- Donation of blood (at least 500 mL), or any amount of platelets or plasma within defined windows prior to dosing.
- Known hypersensitivity to any component of navenibart
- Any condition that the Investigator feels may affect the ability to provide written informed consent or demonstrates unwillingness or inability to comply with trial procedures
- Fortrea Clinical TrialsDaytona Beach, United StatesRecruiting
- Fortrea Clinical TrialsDallas, United StatesRecruiting
- Fortrea Clinical TrialsMadison, United StatesRecruiting