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TD-1607

Phase 1

Infections | Small molecule | Infectious Disease |Theravance Biopharma, Inc.|Trials Updated: Jan 19, 2021

TD-1607 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Feb 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment112

FDA Designations

No designations recorded

TD-1607 clinical trials

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 infections, specifically serious infections due to known or suspected Gram-positive pathogens. It is in Phase 1 clinical development and is not yet 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.

What phase is TD-1607 in?

TD-1607 is in Phase 1 clinical development. It has completed two Phase 1 trials in healthy subjects, and it remains an investigational drug that has not been approved for any use.

What clinical trials is TD-1607 in?

TD-1607 has completed two Phase 1 trials in healthy subjects. The first, NCT01791049, was a single ascending dose study with 64 participants. The second, NCT01949103, was a multiple ascending dose study with 48 participants. Both were conducted in the United States.

Is TD-1607 the same as any other drug?

No alternative names for TD-1607 have been disclosed. It is identified solely by its developmental code TD-1607 in clinical trial registrations.