Recent Updates
Recently added Catalysts

TD-0714

Phase 1

Undisclosed | Small molecule | Other |Theravance Biopharma, Inc.|Trials Updated: Oct 13, 2021

TD-0714 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Dec 2015

TD-0714 target and mechanism

Molecular targetNEP
Target classEnzyme
ModalitySmall molecule

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment106

FDA Designations

No designations recorded

TD-0714 clinical trials

TD-0714 · 2 trials · 2 indications

Phase 1 2
NCT02709928Multiple Ascending Dose Study of TD-0714 in Healthy and Elderly SubjectsHealthy Adults, Elderly Subjects
COMPLETED50 Analytics
NCT02639078Single Ascending Dose Study of TD-0714 in Healthy SubjectsHealthy
COMPLETED56 Analytics
PHASE1COMPLETED
Multiple Ascending Dose Study of TD-0714 in Healthy and Elderly Subjects
Healthy Adults, Elderly SubjectsUnlock trial analytics
PHASE1COMPLETED
Single Ascending Dose Study of TD-0714 in Healthy Subjects
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety of TD-0714 by assessing the number and severity of adverse events, including changes in vital signs, physical examination, laboratory safety tests, and ECGs
From Day 1 through end of study (Day 25)
Safety and tolerability of TD-0714 by assessing the number, severity and type of adverse events, including changes in vital signs, physical and neurological examinations, laboratory safety tests and ECGs
From Day 1 through end of study (Day 10)

Secondary Endpoints

Pharmacokinetics (PK) of TD-0714 in plasma after multiple doses - peak plasma concentration (Cmax)
Day 1 through Day 17
PK of TD-0714 in plasma after multiple doses - time to peak plasma concentration (Tmax)
Day 1 through Day 17
PK of TD-0714 in plasma after multiple doses - time to last measurable concentration (Tlast)
Day 1 through Day 17
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
TD-0714EXPERIMENTALCapsule formulation
PlaceboPLACEBO_COMPARATORCapsule formulation

Interventions

NameTypeDescription
TD-0714DRUG -
PlaceboDRUG -
Placebo ComparatorDRUGOne time dosing in capsule formulation
Unlock Study Design Details

Eligibility Criteria

Age Range19 Years to 80 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Body Mass Index (BMI) 18 to 32 kg/m2 inclusive * Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use highly effective methods of birth control * Women of non-childbearing potential are at least 2 years postmenopausal or are s...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about TD-0714

What is TD-0714?

TD-0714 is an investigational small molecule developed by Theravance Biopharma, Inc. (ticker TBPH). It is a Phase 1 candidate that has been studied in healthy adult and elderly volunteers. The specific therapeutic indication for TD-0714 has not been disclosed.

What does TD-0714 target?

TD-0714 targets neprilysin (NEP), an enzyme. By acting on this enzyme target, TD-0714 is designed as a small molecule therapeutic. The compound is being developed by Theravance Biopharma as part of its research pipeline.

Who makes TD-0714?

TD-0714 is being developed by Theravance Biopharma, Inc., which trades under the ticker TBPH. The company is the sponsor of the clinical studies conducted for this asset.

What phase is TD-0714 in?

TD-0714 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 1 trials have been completed, and no active trials are currently listed.

What clinical trials is TD-0714 in?

TD-0714 has been evaluated in two completed Phase 1 trials. NCT02639078 was a single ascending dose study in 56 healthy subjects, and NCT02709928 was a multiple ascending dose study in 50 healthy and elderly subjects. Both were conducted in the United States.

How was TD-0714 studied in its clinical trials?

Both TD-0714 trials were randomized, double-blind, and placebo-controlled Phase 1 studies in healthy volunteers. NCT02639078 enrolled 56 subjects for single ascending doses, while NCT02709928 enrolled 50 healthy and elderly subjects for multiple ascending doses. Total enrollment across the two studies was 106 participants.