NCT01791049

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

January 19, 2021

Status Verified

January 1, 2021

Enrollment Period

4 months

First QC Date

February 11, 2013

Last Update Submit

January 15, 2021

Conditions

Serious Infections Due to Known or Suspected Gram-positive Pathogens

Keywords

Gram-positiveInfectionsBacterial infections

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability

    Adverse events, laboratory abnormalities, ECGs, and vital sign measurements.

    11 days

Secondary Outcomes (1)

  • Pharmacokinetics

    96 hours

Study Arms (2)

Active

EXPERIMENTAL

Single escalating doses of TD-1607, administered intravenously

Drug: TD-1607

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

TD-1607DRUG
Active
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subject is a healthy nonsmoking male or a female of non-child bearing potential and 18 to 50 years old, inclusive, at Screening. Females are considered to be of non-childbearing potential if they have had a hysterectomy or tubal ligation or are postmenopausal (amenorrheic for at least 2 years) with a follicle-stimulating hormone (FSH) level \>20 IU/L.
  • Subject has a body mass index (BMI) of 19 to 30 kg/m2, inclusive, and weighs at least 50 kg

You may not qualify if:

  • Subject has evidence or history of clinically significant allergic (except for untreated, asymptomatic seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
  • Subject has a history of allergies or hypersensitivities to glycopeptide (e.g., vancomycin), 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PPD Phase 1

Austin, Texas, 78744, United States

Location

MeSH Terms

Conditions

InfectionsBacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses

Study Officials

  • Medical Monitor

    Theravance Biopharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2013

First Posted

February 13, 2013

Study Start

April 1, 2013

Primary Completion

August 1, 2013

Study Completion

October 1, 2013

Last Updated

January 19, 2021

Record last verified: 2021-01

Locations

US(1)