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TP-6076

Phase 1

Healthy Subjects | Small molecule | Other |Innoviva, Inc.|Last Updated: Dec 17, 2021

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Clinical trial landscape

TP-6076 · 1 trial · 1 indication

Phase 1 1
NCT03691584Phase 1, Safety and Bronchopulmonary PK Study in Healthy VolunteersHealthy Subjects
COMPLETED8 Analytics
PHASE1COMPLETED
Phase 1, Safety and Bronchopulmonary PK Study in Healthy Volunteers
Healthy SubjectsUnlock trial analytics

Study Endpoints

Primary Endpoints

Concentrations of TP-6076 in plasma
Up to 2, 4, 8, or 24 hours after the start of the final TP-6076 iv infusion on Day 4.

Pharmacokinetics

Concentrations of TP-6076 in epithelial lining fluid (ELF)
Up to 2, 4, 8, or 24 hours after the start of the final TP-6076 iv infusion on Day 4.
Concentrations of TP-6076 in alveolar macrophages (AMs)
Up to 2, 4, 8, or 24 hours after the start of the final TP-6076 iv infusion on Day 4.
maximum observed concentration (Cmax)
Up to 2, 4, 8, or 24 hours after the start of the final TP-6076 iv infusion on Day 4.
time to maximum observed concentration (Tmax)
Up to 2, 4, 8, or 24 hours after the start of the final TP-6076 iv infusion on Day 4.

Secondary Endpoints

collection of adverse events
Screening through Day 20 (+/- 5 days)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
BAL PK studyEXPERIMENTALBronchoalveolar lavage procedure performed at either 2, 4, 8, or 24 hours after final dose of TP-6076 on Day 4

Interventions

NameTypeDescription
TP-6076DRUGThe 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 lavagePROCEDURESubjects 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.
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:United Kingdom
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Frequently asked questions about TP-6076

What is TP-6076 used for?

TP-6076 is an investigational small molecule being studied in healthy subjects. It is currently in Phase 1 clinical development, with a completed trial evaluating its safety and bronchopulmonary pharmacokinetics in healthy volunteers. The drug is not approved and remains under investigation.

Who makes TP-6076?

TP-6076 is being developed by Innoviva, Inc., a company traded on the Nasdaq under the ticker INVA. The company is conducting clinical research on this investigational small molecule in healthy subjects.

What phase is TP-6076 in?

TP-6076 is in Phase 1 clinical development. It is an investigational drug, not yet approved, and is being studied in healthy subjects. One Phase 1 trial has been completed, and the drug remains in early-stage clinical research.

What clinical trials is TP-6076 in?

TP-6076 has one completed Phase 1 trial, NCT03691584, titled 'Phase 1, Safety and Bronchopulmonary PK Study in Healthy Volunteers.' This study enrolled 8 participants in the United Kingdom and evaluated the drug's safety and pharmacokinetics in healthy subjects.

Is TP-6076 FDA approved?

TP-6076 is not FDA approved. It is an investigational small molecule currently in Phase 1 clinical development. The drug has completed a Phase 1 trial in healthy subjects, but it remains under investigation and has not been approved for any use.