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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03691584 | Phase 1, Safety and Bronchopulmonary PK Study in Healthy Volunteers | PHASE1 | COMPLETED | 8 | — | — | Nov 26, 2018 | Dec 18, 2019 | Dec 17, 2021 | 1 | United Kingdom |
Pharmacokinetics
| Arm | Type | Description |
|---|---|---|
| BAL PK study | EXPERIMENTAL | Bronchoalveolar lavage procedure performed at either 2, 4, 8, or 24 hours after final dose of TP-6076 on Day 4 |
| Name | Type | Description |
|---|---|---|
| TP-6076 | DRUG | The dose planned to be administered in this study is an iv infusion of 30 mg TP 6076 q24h for 4 consecutive days (starting on Day 1 and ending on Day 4). |
| Bronchoalveolar lavage | PROCEDURE | Subjects will be randomized to undergo a BAL at a single time point: either 2, 4, 8, or 24 hours after the start of the final TP-6076 iv infusion on Day 4. |
Inclusion Criteria: * The following inclusion criteria must be met for a subject to be eligible for inclusion in the study: 1. Status : Healthy subject 2. Gender : Male or female 3. Age : 18 to 50 years, inclusive, at screening 4. Body mass index (BMI) : 18.0 to 30.0 kg/m2, inclusive, at s...