TD-1607 MAD Study in Healthy Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Infections, Bacterial Infections

In brief

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

Key facts

Study ID

NCT01949103

Run by

Theravance Biopharma

People needed

48

Starts

2013-10-01

Expected to finish

2014-07-01

Last updated by the study team

2021-01-19

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• PPD, Phase 1 Clinic — Austin, Texas, United States

Full record on ClinicalTrials.gov

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