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A Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of TBI-223 in Healthy Adults

NCT03758612 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2024-12-09

Study results available
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Summary

Partially-Blinded, Placebo-Controlled, Randomized, Single Ascending Dose (SAD) with a Food Effect Cohort to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBI-223 in Healthy Adults.

Conditions

Interventions

DRUG

TBI-223 oral suspension

TBI-223 oral suspension, orally administered.

DRUG

TBI-223 enteric capsule

TBI-223 enteric capsules filled with 150 mg of TBI-223 powder, orally administered.

DRUG

TBI-223 SR Tablet Prototype 1

TBI-223 600 mg sustained-release (SR) tablet Prototype 1, orally administered.

DRUG

TBI-223 SR Tablet Prototype 2

TBI-223 600 mg SR tablet Prototype 2, orally administered.

DRUG

TBI-223 SR Tablet Prototype 3

TBI-223 900 mg SR tablet Prototype 3, orally administered.

DRUG

TBI-223 IR Tablet

TBI-223 1000 mg immediate release (IR) tablet, orally administered

DRUG

Placebo suspension

Placebo for TBI-223 oral Suspension; orally administered.

Sponsors & Collaborators

  • Global Alliance for TB Drug Development

    lead OTHER

Principal Investigators

  • Jerry Nedelman · Global Alliance for TB Drug Development

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-01-16
Primary Completion
2020-03-15
Completion
2020-03-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT03758612 on ClinicalTrials.gov