TD-1607 MAD Study in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-07-31

Brief Summary

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

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Detailed Description

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Conditions

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Infections Bacterial Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TD-1607 or placebo (Dose1)

TD-1607 or placebo administered intravenously

Group Type EXPERIMENTAL

TD-1607

Intervention Type DRUG

Placebo

Intervention Type DRUG

TD-1607 or placebo (Dose 2)

TD-1607 or placebo administered intravenously

Group Type EXPERIMENTAL

TD-1607

Intervention Type DRUG

Placebo

Intervention Type DRUG

TD-1607 or placebo (Dose 3)

TD-1607 or placebo administered intravenously

Group Type EXPERIMENTAL

TD-1607

Intervention Type DRUG

Placebo

Intervention Type DRUG

TD-1607 or placebo (Dose 4)

TD-1607 or placebo administered intravenously

Group Type EXPERIMENTAL

TD-1607

Intervention Type DRUG

Placebo

Intervention Type DRUG

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

TD-1607 or placebo administered intravenously

Group Type EXPERIMENTAL

TD-1607

Intervention Type DRUG

Placebo

Intervention Type DRUG

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

TD-1607 or placebo administered intravenously

Group Type EXPERIMENTAL

TD-1607

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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TD-1607

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes