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Phase 1, Safety and Bronchopulmonary PK Study in Healthy Volunteers

NCT03691584 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2021-12-17

No results posted yet for this study

Summary

This is a Phase 1, open-label, randomized, PK and safety study in a maximum of 25 healthy subjects who have provided a bronchoalveolar lavage (BAL) sample.

Conditions

  • Healthy Subjects

Interventions

DRUG

TP-6076

The dose planned to be administered in this study is an iv infusion of 30 mg TP 6076 q24h for 4 consecutive days (starting on Day 1 and ending on Day 4).

PROCEDURE

Bronchoalveolar lavage

Subjects will be randomized to undergo a BAL at a single time point: either 2, 4, 8, or 24 hours after the start of the final TP-6076 iv infusion on Day 4.

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • Tetraphase Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Jeremy Dennison, MD · Hammersmith Medicines Research

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-26
Primary Completion
2019-06-30
Completion
2019-12-18

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03691584 on ClinicalTrials.gov