TD-1607 MAD Study in Healthy Subjects

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Theravance Biopharma; Theravance Biopharma Antibiotics, Inc.

Criteria

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.