TD-1607 SAD Study in Healthy Subjects
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 9/13/2018 |
| Start Date: | April 2013 |
| End Date: | October 2013 |
A Randomized, Double−Blind, Placebo−Controlled, Single Ascending Dose (SAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TD-1607, a Glycopeptide−Cephalosporin Heterodimer Gram−Positive Antibiotic, in Healthy Subjects
TD-1607, administered intravenously as single doses, will be investigated in healthy subjects
to assess its tolerability, safety, and pharmacokinetics.
to assess its tolerability, safety, and pharmacokinetics.
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).
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