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INBRX-101/rhAAT-Fc · 1 trial · 2 indications
Adverse events will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03.
Severity of adverse events will be assessed and assigned by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03.
| Arm | Type | Description |
|---|---|---|
| Part 1 Single Ascending Dose | EXPERIMENTAL | INBRX-101 will be escalated in subjects with alpha-1 antitrypsin deficiency (AATD). |
| Part 2 Multiple Ascending Dose | EXPERIMENTAL | INBRX-101 will be escalated in subjects with alpha-1 antitrypsin deficiency (AATD). |
| Name | Type | Description |
|---|---|---|
| INBRX-101/rhAAT-Fc | DRUG | INBRX-101 is a recombinant human alpha-1 antitrypsin (AAT) Fc fusion protein (rhAAT-Fc). |
Inclusion Criteria: * Documented alpha-1 antitrypsin (AAT) serum concentration \<11 μM. * Diagnosis of alpha-1 antitrypsin deficiency (AATD) with any allelic combination with exception of the null/null genotype. * For subjects in Part 2 80 and 120 mg/kg cohorts ONLY: post-bronchodilator FEV1 of at ...
INBRX-101 is an investigational therapy being developed for the treatment of Alpha-1 Antitrypsin Deficiency (AATD), a rare genetic condition. It is designed to address the underlying deficiency of alpha-1 antitrypsin protein. The drug is currently in clinical development and has not been approved by regulatory authorities.
INBRX-101 is being developed by Inhibrx Biosciences, Inc., a biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol INBX. Inhibrx is conducting clinical trials to evaluate the safety and efficacy of INBRX-101 in patients with Alpha-1 Antitrypsin Deficiency.
INBRX-101 is in Phase 1 clinical development. A Phase 1 study has been completed to assess its safety, pharmacokinetics, and pharmacodynamics in adults with Alpha-1 Antitrypsin Deficiency. The drug is still investigational and has not received FDA approval for any indication.
INBRX-101 has been studied in a Phase 1 clinical trial with the identifier NCT03815396. This completed trial enrolled 31 participants with Alpha-1 Antitrypsin Deficiency across the United States, New Zealand, and the United Kingdom. The study was controlled but not randomized or double-blinded.
Yes, INBRX-101 is also known as rhAAT-Fc. This alternative name refers to the recombinant human alpha-1 antitrypsin with an Fc fusion component. Both names refer to the same investigational drug being developed for Alpha-1 Antitrypsin Deficiency.