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TD-6450

Phase 1

Hepatitis C | Small molecule | Infectious Disease |Theravance Biopharma, Inc.|Last Updated: Jan 19, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment158

FDA Designations

No designations recorded

Clinical trial landscape

TD-6450 · 2 trials · 2 indications

Phase 1 2
NCT02116543TD-6450 MAD Study in HCV Infected SubjectsHepatitis C
COMPLETED47 Analytics
NCT02022306TD-6450 SAD and MAD in Healthy SubjectsHepatitis C
COMPLETED111 Analytics
PHASE1COMPLETED
TD-6450 MAD Study in HCV Infected Subjects
Hepatitis CUnlock trial analytics
PHASE1COMPLETED
TD-6450 SAD and MAD in Healthy Subjects
Hepatitis CUnlock trial analytics

Study Endpoints

Primary Endpoints

Adverse events
28 Days

Number, type, severity, and association of treatment emergent adverse events.

Secondary Endpoints

Cmax
28 Days
Tmax
28 Days
AUC0-t
28 Days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TD-6450EXPERIMENTALTD-6450 capsules
PlaceboPLACEBO_COMPARATORPlacebo capsules
SAD TD-6450PLACEBO_COMPARATORSingle ascending dose (Part A)
MAD TD-6450PLACEBO_COMPARATORMultiple ascending dose (Part B)
Food effect of TD-6450ACTIVE_COMPARATORFood effect will be assessed in Part A (SAD) of this study.

Interventions

NameTypeDescription
TD-6450DRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subject is HCV antibody positive * Subject is treatment naïve, with no history of exposure (single or multiple dose) to interferon, ribavirin or direct acting antivirals. * Subject has had a liver biopsy within 3 years or Fibroscan evaluation within 6 months prior to Screening...

Countries:United States
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Competitive Landscape -Hepatitis C 11 trials

Frequently asked questions about TD-6450

What is TD-6450 used for?

TD-6450 is an investigational small molecule being developed for the treatment of Hepatitis C. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in both healthy subjects and patients with Hepatitis C infection.

Who makes TD-6450?

TD-6450 is being developed by Theravance Biopharma, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol TBPH. The drug is currently in Phase 1 clinical development for the treatment of Hepatitis C.

What phase is TD-6450 in?

TD-6450 is in Phase 1 clinical development. It is an investigational drug for the treatment of Hepatitis C and has not yet been approved by regulatory authorities. The drug is still in early-stage clinical trials to evaluate its safety and tolerability.

What clinical trials is TD-6450 in?

TD-6450 has completed two Phase 1 clinical trials. The first trial, NCT02022306, was a single and multiple ascending dose study in healthy subjects with 111 participants. The second trial, NCT02116543, was a multiple ascending dose study in 47 patients with Hepatitis C. Both trials were conducted in the United States.

Is TD-6450 FDA approved?

TD-6450 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for the treatment of Hepatitis C. The drug has completed two Phase 1 trials, but it has not yet received regulatory approval and remains under clinical investigation.