TD-1607 SAD Study in Healthy Subjects
Completed · Phase 1 · Has a placebo group
Conditions studied: Serious Infections Due to Known or Suspected Gram-positive Pathogens
In brief
TD-1607, administered intravenously as single doses, will be investigated in healthy subjects to assess its tolerability, safety, and pharmacokinetics.
Key facts
- Study ID
- NCT01791049
- Run by
- Theravance Biopharma
- People needed
- 64
- Starts
- 2013-04-01
- Expected to finish
- 2013-10-01
- Last updated by the study team
- 2021-01-19
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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).
Where it is running
- PPD Phase 1 — Austin, Texas, United States
Full record on ClinicalTrials.gov
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