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Evaluation of the Safety, Tolerability, PK of TBAJ-587 in Healthy Adults

NCT04890535 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2023-05-19

No results posted yet for this study

Summary

Phase 1, Partially Blinded, Placebo-Controlled, Randomized, Combined Single Ascending Dose with Food Effect Cohort Trial (Part 1) and Multiple Ascending Dose Trial (Part 2) to Evaluate the Safety, Tolerability, and PK of TBAJ-587 in Healthy Adults

Conditions

Interventions

DRUG

TBAJ-587

oral suspension

DRUG

Placebo

matching placebo oral suspension for TBAJ-587

Sponsors & Collaborators

  • QPS Holdings LLC

    collaborator INDUSTRY

  • Global Alliance for TB Drug Development

    lead OTHER

Principal Investigators

  • Paul Bruinenberg, MD, MBA · Global Alliance for TB Drug Development

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2023-02-27
Completion
2023-02-27

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT04890535 on ClinicalTrials.gov