Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03815396 | Phase 1 Study to Assess the Safety, PK and PD of INBRX-101 in Adults With Alpha-1 Antitrypsin Deficiency | PHASE1 | COMPLETED | 31 | — | — | Jul 19, 2019 | Aug 18, 2022 | Sep 13, 2022 | 10 | United States, New Zealand +1 |
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 ...