TD-1607 MAD Study in Healthy Subjects
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 9/13/2018 |
| Start Date: | October 2013 |
| End Date: | July 2014 |
A Randomized, Double−Blind, Placebo−Controlled, Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TD−1607, a Glycopeptide−Cephalosporin Heterodimer Antibiotic, in Healthy Subjects
TD-1607, administered intravenously as multiple ascending doses, will be investigated in
healthy subjects to assess its tolerability, safety, and pharmacokinetics.
healthy subjects to assess its tolerability, safety, and pharmacokinetics.
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.
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