Status:
COMPLETED
TD-1607 SAD Study in Healthy Subjects
Lead Sponsor:
Theravance Biopharma
Conditions:
Serious Infections Due to Known or Suspected Gram-positive Pathogens
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
TD-1607, administered intravenously as single doses, will be investigated in healthy subjects to assess its tolerability, safety, and pharmacokinetics.
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT01791049
Start Date
April 1 2013
End Date
October 1 2013
Last Update
January 19 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
PPD Phase 1
Austin, Texas, United States, 78744