Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TP-6076 · 1 trial · 1 indication
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...
TP-6076 is an investigational small molecule therapeutic being developed by Innoviva, Inc. It has been studied in a Phase 1 clinical trial in healthy volunteers. The specific disease or condition it is intended to treat has not been publicly disclosed.
TP-6076 is being developed by Innoviva, Inc., which trades on the Nasdaq under the ticker INVA. Innoviva is the sponsor of the clinical program for this asset.
TP-6076 is in Phase 1 clinical development. It is an investigational drug and is not approved by the FDA. One Phase 1 trial has been completed, and no active trials are currently listed for this asset.
TP-6076 has been evaluated in one completed Phase 1 trial, NCT03691584, titled a Phase 1 Safety and Bronchopulmonary PK Study in Healthy Volunteers. The trial enrolled 8 healthy adult participants in the United Kingdom and was an uncontrolled study without randomization or blinding.
The TP-6076 Phase 1 trial, NCT03691584, was an uncontrolled, open-label study conducted in the United Kingdom. It enrolled 8 healthy volunteers aged 18 years and older of all sexes. The study assessed safety and bronchopulmonary pharmacokinetics and has been completed.