TD-1607 SAD Study in Healthy Subjects

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Theravance Biopharma

Status and phase

Completed
Phase 1

Conditions

Serious Infections Due to Known or Suspected Gram-positive Pathogens

Treatments

Drug: TD-1607
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01791049
0098

Details and patient eligibility

About

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

Enrollment

64 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Subject is a healthy nonsmoking male or a female of non-child bearing potential and 18 to 50 years old, inclusive, at Screening. Females are considered to be of non-childbearing potential if they have had a hysterectomy or tubal ligation or are postmenopausal (amenorrheic for at least 2 years) with a follicle-stimulating hormone (FSH) level >20 IU/L.
  • Subject has a body mass index (BMI) of 19 to 30 kg/m2, inclusive, and weighs at least 50 kg

Exclusion criteria

  • Subject has evidence or history of clinically significant allergic (except for untreated, asymptomatic seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
  • Subject has a history of allergies or hypersensitivities to glycopeptide (e.g., vancomycin), 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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Triple Blind

64 participants in 2 patient groups, including a placebo group

Active
Experimental group
Description:
Single escalating doses of TD-1607, administered intravenously
Treatment:
Drug: TD-1607
Placebo
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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