TD-1607 MAD Study in Healthy Subjects

Theravance Biopharma

Status and phase: Completed; Phase 1

Conditions: Infections; Bacterial Infections

Treatments: Drug: Placebo; Drug: TD-1607

Study type: Interventional

Funder types: Industry

Identifiers

NCT01949103

0104 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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48 participants in 6 patient groups

TD-1607 or placebo (Dose1)

Experimental group

Description:

TD-1607 or placebo administered intravenously

Treatment:

Drug: Placebo

Drug: TD-1607

TD-1607 or placebo (Dose 2)

Experimental group

Description:

TD-1607 or placebo administered intravenously

Treatment:

Drug: Placebo

Drug: TD-1607

TD-1607 or placebo (Dose 3)

Experimental group

Description:

TD-1607 or placebo administered intravenously

Treatment:

Drug: Placebo

Drug: TD-1607

TD-1607 or placebo (Dose 4)

Experimental group

Description:

TD-1607 or placebo administered intravenously

Treatment:

Drug: Placebo

Drug: TD-1607

TD-1607 or placebo (Dose 5) [Optional]

Experimental group

Description:

TD-1607 or placebo administered intravenously

Treatment:

Drug: Placebo

Drug: TD-1607

TD-1607 or placebo (Dose 6) [Optional]

Experimental group

Description:

TD-1607 or placebo administered intravenously

Treatment:

Drug: Placebo

Drug: TD-1607