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TD-1607 MAD Study in Healthy Subjects

Theravance Biopharma logo

Theravance Biopharma

Status and phase

Completed
Phase 1

Conditions

Infections
Bacterial Infections

Treatments

Drug: Placebo
Drug: TD-1607

Study type

Interventional

Funder types

Industry

Identifiers

NCT01949103
0104 (Other Identifier)

Details and patient eligibility

About

TD-1607, administered intravenously as multiple ascending doses, will be investigated in healthy subjects to assess its tolerability, safety, and pharmacokinetics.

Enrollment

48 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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 in the results of laboratory evaluations at Screening and Day -1.

Exclusion criteria

  • Subject has evidence or history of clinically significant, relevant hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (except for untreated, asymptomatic seasonal allergies at time of dosing).
  • Subject has a history of allergies or hypersensitivities to glycopeptide (e.g., vancomycin) or beta-lactam (e.g., penicillin or cephalosporin) antibiotics.
  • Subject has participated in another clinical trial of an investigational drug (or medical device) within 60 days (or 5 half-lives, whichever is longer) prior to Screening or is currently participating in another trial of an investigational drug (or medical device).
  • Subject has previously participated in a trial for TD-1607.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Quadruple Blind

48 participants in 6 patient groups

TD-1607 or placebo (Dose1)
Experimental group
Description:
TD-1607 or placebo administered intravenously
Treatment:
Drug: Placebo
Drug: TD-1607
TD-1607 or placebo (Dose 2)
Experimental group
Description:
TD-1607 or placebo administered intravenously
Treatment:
Drug: Placebo
Drug: TD-1607
TD-1607 or placebo (Dose 3)
Experimental group
Description:
TD-1607 or placebo administered intravenously
Treatment:
Drug: Placebo
Drug: TD-1607
TD-1607 or placebo (Dose 4)
Experimental group
Description:
TD-1607 or placebo administered intravenously
Treatment:
Drug: Placebo
Drug: TD-1607
TD-1607 or placebo (Dose 5) [Optional]
Experimental group
Description:
TD-1607 or placebo administered intravenously
Treatment:
Drug: Placebo
Drug: TD-1607
TD-1607 or placebo (Dose 6) [Optional]
Experimental group
Description:
TD-1607 or placebo administered intravenously
Treatment:
Drug: Placebo
Drug: TD-1607

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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