TD-1607 MAD Study in Healthy Subjects

NCT01949103 | Completed Phase 1

• 1 other identifier: 0104
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Infections; Bacterial Infections

Keywords

Gram-positive

Outcome Measures

Primary Outcomes (1)

• Number of adverse events

  Adverse events

  17 days

Secondary Outcomes (12)

• Cmax

  17 Days

• Tmax

  17 Days

• AUC0-t

  17 Days

• AUC0-24

  17 Days

• AUCinf

  17 Days

Study Arms (6)

TD-1607 or placebo (Dose1)

EXPERIMENTAL

TD-1607 or placebo administered intravenously

Drug: TD-1607; Drug: Placebo

TD-1607 or placebo (Dose 2)

EXPERIMENTAL

TD-1607 or placebo administered intravenously

Drug: TD-1607; Drug: Placebo

TD-1607 or placebo (Dose 3)

EXPERIMENTAL

TD-1607 or placebo administered intravenously

Drug: TD-1607; Drug: Placebo

TD-1607 or placebo (Dose 4)

EXPERIMENTAL

TD-1607 or placebo administered intravenously

Drug: TD-1607; Drug: Placebo

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

EXPERIMENTAL

TD-1607 or placebo administered intravenously

Drug: TD-1607; Drug: Placebo

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

EXPERIMENTAL

TD-1607 or placebo administered intravenously

Drug: TD-1607; Drug: Placebo

Interventions

TD-1607 DRUG

TD-1607 or placebo (Dose 2); TD-1607 or placebo (Dose 3); TD-1607 or placebo (Dose 4); TD-1607 or placebo (Dose 5) [Optional]; TD-1607 or placebo (Dose 6) [Optional]; TD-1607 or placebo (Dose1)

Placebo DRUG

TD-1607 or placebo (Dose 2); TD-1607 or placebo (Dose 3); TD-1607 or placebo (Dose 4); TD-1607 or placebo (Dose 5) [Optional]; TD-1607 or placebo (Dose 6) [Optional]; TD-1607 or placebo (Dose1)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Theravance Biopharma: lead

Study Sites (1)

PPD, Phase 1 Clinic

Austin, Texas, 78744, United States

Location

MeSH Terms

Conditions

Infections; Bacterial 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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2013
• First Posted: September 24, 2013
• Study Start: October 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: January 19, 2021

Record last verified: 2021-01

Locations

US (1)