TD-1607 MAD Study in Healthy Subjects

January 15, 2021 updated by: Theravance Biopharma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78744
        • PPD, Phase 1 Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TD-1607 or placebo (Dose1)
TD-1607 or placebo administered intravenously
Drug: Placebo
Drug: TD-1607
Experimental: TD-1607 or placebo (Dose 2)
TD-1607 or placebo administered intravenously
Drug: Placebo
Drug: TD-1607
Experimental: TD-1607 or placebo (Dose 3)
TD-1607 or placebo administered intravenously
Drug: Placebo
Drug: TD-1607
Experimental: TD-1607 or placebo (Dose 4)
TD-1607 or placebo administered intravenously
Drug: Placebo
Drug: TD-1607
Experimental: TD-1607 or placebo (Dose 5) [Optional]
TD-1607 or placebo administered intravenously
Drug: Placebo
Drug: TD-1607
Experimental: TD-1607 or placebo (Dose 6) [Optional]
TD-1607 or placebo administered intravenously
Drug: Placebo
Drug: TD-1607

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of adverse events
Time Frame: 17 days
Adverse events
17 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: 17 Days
Pharmacokinetics
17 Days
Tmax
Time Frame: 17 Days
Pharmacokinetics
17 Days
AUC0-t
Time Frame: 17 Days
Pharmacokinetics
17 Days
AUC0-24
Time Frame: 17 Days
Pharmacokinetics
17 Days
AUCinf
Time Frame: 17 Days
Pharmacokinetics
17 Days
CL
Time Frame: 17 Days
Pharmacokinetics
17 Days
Vdss
Time Frame: 17 Days
Pharmacokinetics
17 Days
t1/2
Time Frame: 17 Days
Pharmacokinetics
17 Days
Amount excreted in urine (Ae
Time Frame: 17 Days
Pharmacokinetics
17 Days
Fraction eliminated in urine (fe)
Time Frame: 17 Days
Pharmacokinetics
17 Days
CLr
Time Frame: 17 Days
Pharmacokinetics
17 Days
Ctrough
Time Frame: 17 Days
Pharmacokinetics
17 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theravance Biopharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

September 17, 2013

First Submitted That Met QC Criteria

September 23, 2013

First Posted (Estimate)

September 24, 2013

Study Record Updates

Last Update Posted (Actual)

January 19, 2021

Last Update Submitted That Met QC Criteria

January 15, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0104 (CCOP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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