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TD-1607

Phase 1

Infections | 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-BlindCONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

TD-1607 · 2 trials · 3 indications

Phase 1 2
NCT01949103TD-1607 MAD Study in Healthy SubjectsInfections
COMPLETED48 Analytics
NCT01791049TD-1607 SAD Study in Healthy SubjectsSerious Infections Due to Known or Suspected Gram-positive Pathogens
COMPLETED64 Analytics
PHASE1COMPLETED
TD-1607 MAD Study in Healthy Subjects
InfectionsUnlock trial analytics
PHASE1COMPLETED
TD-1607 SAD Study in Healthy Subjects
Serious Infections Due to Known or Suspected Gram-positive PathogensUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of adverse events
17 days

Adverse events

Safety and tolerability
11 days

Adverse events, laboratory abnormalities, ECGs, and vital sign measurements.

Secondary Endpoints

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

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TD-1607 or placebo (Dose1)EXPERIMENTALTD-1607 or placebo administered intravenously
TD-1607 or placebo (Dose 2)EXPERIMENTALTD-1607 or placebo administered intravenously
TD-1607 or placebo (Dose 3)EXPERIMENTALTD-1607 or placebo administered intravenously
TD-1607 or placebo (Dose 4)EXPERIMENTALTD-1607 or placebo administered intravenously
TD-1607 or placebo (Dose 5) [Optional]EXPERIMENTALTD-1607 or placebo administered intravenously
TD-1607 or placebo (Dose 6) [Optional]EXPERIMENTALTD-1607 or placebo administered intravenously
ActiveEXPERIMENTALSingle escalating doses of TD-1607, administered intravenously
PlaceboPLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
TD-1607DRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subject is a healthy nonsmoking male or a female (of non-childbearing potential) and 18 to 55 years old, inclusive, at Screening. * Subject has a body mass index (BMI) of 19 to 30 kg/m2, inclusive, and weighs at least 50 kg. Subject has no clinically significant abnormalities...

Countries:United States
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Frequently asked questions about TD-1607

What is TD-1607 used for?

TD-1607 is an investigational small molecule being developed for serious infections due to known or suspected Gram-positive pathogens, as well as for bacterial infections. It is currently in Phase 1 clinical development and has not been approved by the FDA.

Who makes TD-1607?

TD-1607 is being developed by Theravance Biopharma, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol TBPH. The company is conducting clinical trials for this investigational drug in the United States.

What phase is TD-1607 in?

TD-1607 is in Phase 1 clinical development. Two Phase 1 trials have been completed, including a single ascending dose study and a multiple ascending dose study in healthy subjects. The drug remains investigational and is not yet approved.

What clinical trials is TD-1607 in?

TD-1607 has been studied in two completed Phase 1 clinical trials: NCT01791049, a single ascending dose study in healthy subjects with 64 participants, and NCT01949103, a multiple ascending dose study in healthy subjects with 48 participants. Both trials were conducted in the United States.

Is TD-1607 the same as any other drug?

TD-1607 is the primary name for this investigational drug. No alternative names have been associated with it in the available clinical trial data. It is a small molecule being developed by Theravance Biopharma for Gram-positive infections.