Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Autoinjector, Vial and syringe · 1 trial · 1 indication
Plasma concentrations are assessed via a validated method and used to estimate PK parameters via noncompartmental analysis.
Plasma concentrations are assessed via a validated method and used to estimate PK parameters via noncompartmental analysis.
| Arm | Type | Description |
|---|---|---|
| Navenibart vial and syringe | ACTIVE_COMPARATOR | - |
| Navenibart autoinjector | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Autoinjector | COMBINATION_PRODUCT | Navenibart administered subcutaneously via autoinjector |
| Vial and syringe | DRUG | Navenibart administered subcutaneously via vial and syringe |
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 3...
The Autoinjector, Vial and syringe is used in a Phase 1 clinical trial to compare the pharmacokinetics of two presentations of Navenibart in healthy adult participants. The study is being conducted in the United States and is currently recruiting participants.
The Autoinjector, Vial and syringe is developed by Astria Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ATXS. The company is conducting a Phase 1 trial to evaluate the pharmacokinetics of two presentations of Navenibart in healthy participants.
The Autoinjector, Vial and syringe is in Phase 1 clinical development. It is an investigational product being studied in a single active-controlled trial that is currently recruiting participants. The trial is not yet completed, and the product has not been approved for any use.
The Autoinjector, Vial and syringe is being evaluated in clinical trial NCT07635095, titled 'A Trial to Compare the Pharmacokinetics of Two Presentations of Navenibart in Healthy Participants.' This Phase 1 study is recruiting 180 healthy adult participants in the United States.
The Autoinjector, Vial and syringe refers to the delivery presentations of Navenibart being compared in a clinical trial. The study NCT07635095 is designed to compare the pharmacokinetics of these two presentations of Navenibart in healthy participants.