NCT04493671

Brief Summary

A Phase 1, Partially Blind, Placebo Controlled, Randomized, Combined Single Ascending Dose (SAD) with a Food Effect Cohort (Part 1), Multiple Ascending Dose (MAD) (Part 2), and Relative Bioavailability (rBA) (Part 3) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBAJ-876 in Healthy Adult Subjects

Trial Health

87
On Track

Trial Health Score

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

Enrollment
137

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2020

Typical duration 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

Study Start

First participant enrolled

June 8, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 22, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 30, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
Last Updated

June 4, 2025

Status Verified

May 1, 2025

Enrollment Period

2 years

First QC Date

July 22, 2020

Last Update Submit

May 29, 2025

Conditions

Pulmonary DiseaseTuberculosis, PulmonaryTuberculosisMulti Drug Resistant TuberculosisDrug Sensitive TuberculosisDrug-resistant TuberculosisMycobacterium Tuberculosis Infection

Keywords

TBAJ-876DiarylquinolineDARQ

Outcome Measures

Primary Outcomes (3)

  • Number of Participants with Treatment-Related Adverse Events in Part 1, Single Ascending Dose

    Subjects will be monitored for any adverse events from the signing of the consent form until the end-of-study visit. The Investigator or a Sub-Investigator will assess its relationship to the study drug.

    Day 1 to Day 28

  • Number of Participants with Treatment-Related Adverse Events in Part 2, Multiple Ascending Dose

    Subjects will be monitored for any adverse events from the signing of the consent form until the end-of-study visit. The Investigator or a Sub-Investigator will assess its relationship to the study drug.

    Day 1 to Day 133

  • Number of Participants with Treatment-Related Adverse Events in Part 3, Relative Bioavailability Study

    Subjects will be monitored for any adverse events from the signing of the consent form until the end-of-study visit. The Investigator or a Sub-Investigator will assess its relationship to the study drug.

    Day 1 to Day 21

Secondary Outcomes (16)

  • AUCExtrap [Pharmacokinetic Analysis]

    Days 1 - 28

  • AUCinf [Pharmacokinetic Analysis]

    Days 1 - 28

  • AUClast [Pharmacokinetic Analysis]

    Days 1 - 28

  • AUCtau [Pharmacokinetic Analysis]

    Days 1 - 28

  • Cavg [Pharmacokinetic Analysis]

    Days 1 - 28

  • +11 more secondary outcomes

Study Arms (16)

TBAJ-876 10mg SAD

ACTIVE COMPARATOR

Cohort 1 single dose of 10 mg TBAJ-876 (n=6) under fasted conditions

Drug: TBAJ-876 suspension

TBAJ-876 25mg SAD

ACTIVE COMPARATOR

Cohort 2, Single dose of 25 mg TBAJ-876 (n=6) under fasted conditions

Drug: TBAJ-876 suspension

TBAJ-876 50mg SAD

ACTIVE COMPARATOR

Cohort 3 single dose of 50 mg TBAJ-876 (n=6) under fasted conditions

Drug: TBAJ-876 suspension

TBAJ-876 100mg fasted SAD

ACTIVE COMPARATOR

Cohort 4, single dose of 100 mg TBAJ-876 (n=9) under fasted conditions

Drug: TBAJ-876 suspension

TBAJ-876 100mg fed SAD

ACTIVE COMPARATOR

Cohort 4, dose of 100 mg TBAJ-876 (n=10) under fed conditions

Drug: TBAJ-876 suspension

TBAJ-876 200mg SAD

ACTIVE COMPARATOR

Cohort 5 single dose of 200 mg TBAJ-876 (n=6) under fasted conditions

Drug: TBAJ-876 suspension

TBAJ-876 400mg SAD

ACTIVE COMPARATOR

Cohort 6, single dose of 400 mg TBAJ-876) (n=6) under fasted conditions

Drug: TBAJ-876 suspension

TBAJ-876 800mg SAD

ACTIVE COMPARATOR

Cohort 7, Single dose of 800 mg TBAJ-876 (n=6) under fasted conditions

Drug: TBAJ-876 suspension

TBAJ-876 Placebo SAD

PLACEBO COMPARATOR

Single dose matching placebo for TBAJ-876 under fasted conditions (n=13)

Drug: Placebo suspension

TBAJ-876 25mg MAD

ACTIVE COMPARATOR

25 mg TBAJ-876 (n=9) for 14 days under fed conditions

Drug: TBAJ-876 suspension

TBAJ-876 75mg MAD

ACTIVE COMPARATOR

75 mg TBAJ-876) (n=9) for 14 days under fed conditions

Drug: TBAJ-876 suspension

TBAJ-876 200mg MAD

ACTIVE COMPARATOR

200 mg TBAJ-876 (n=9) for 14 days under fed conditions

Drug: TBAJ-876 suspension

TBAJ-876 Placebo MAD

PLACEBO COMPARATOR

Matching placebo for TBAJ-876 for 14 days under fed conditions (n=12)

Drug: Placebo suspension

TBAJ-876 1x100 mg rBA fasted

ACTIVE COMPARATOR

Single dose TBAJ-876 of 100 mg (1 x 100 mg tablet) (n=10) under fasted conditions

Drug: TBAJ-876 100 mg tablet

TBAJ-876 1x100 mg rBA fed

ACTIVE COMPARATOR

Single dose TBAJ-876 of 100 mg (1 x 100 mg tablet) (n=10) under fed conditions

Drug: TBAJ-876 100 mg tablet

TBAJ-876 4x25 mg rBA fasted

ACTIVE COMPARATOR

Single dose TBAJ-876 of 100 mg (4 x 25 mg tablets) (n=10) under fasted conditions

Drug: TBAJ-876 25 mg tablet

Interventions

TBAJ-876 suspensionDRUG

TBAJ-876 oral suspension, orally administered

TBAJ-876 100mg fasted SADTBAJ-876 100mg fed SADTBAJ-876 10mg SADTBAJ-876 200mg MADTBAJ-876 200mg SADTBAJ-876 25mg MADTBAJ-876 25mg SADTBAJ-876 400mg SADTBAJ-876 50mg SADTBAJ-876 75mg MADTBAJ-876 800mg SAD
Placebo suspensionDRUG

Placebo for TBAJ-876 oral Suspension; orally administered

TBAJ-876 Placebo MADTBAJ-876 Placebo SAD
TBAJ-876 100 mg tabletDRUG

TBAJ-876 100 mg tablets, orally administered

TBAJ-876 1x100 mg rBA fastedTBAJ-876 1x100 mg rBA fed
TBAJ-876 25 mg tabletDRUG

TBAJ-876 25 mg tablets, orally administered

TBAJ-876 4x25 mg rBA fasted

Eligibility Criteria

Age19 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All volunteers must satisfy the following criteria to be considered for study participation:
  • Is a healthy adult male or female, 19 to 50 years of age (inclusive) at the time of screening.
  • Has a body mass index (BMI) ≥18.5 and ≤32.0 (kg/m2) and a body weight of no less than 50.0 kg.
  • Is medically healthy with no clinically significant screening results (e.g., laboratory profiles normal or up to Grade 1 per DMID Toxicity Tables), as deemed by the Investigator.
  • Has not used tobacco- or nicotine-containing products (including smoking cessation products), for a minimum of 6 months before dosing.
  • If assigned to receive study drug under fed conditions, is willing and able to consume the entire high-calorie, high-fat breakfast meal in the timeframe required.

You may not qualify if:

  • History or presence of clinically significant cardiovascular (heart murmur), pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
  • Any presence of musculoskeletal toxicity (severe tenderness with marked impairment of activity, or frank necrosis).
  • Has a positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV at screening.
  • Current or history of prolonged QT syndrome15. Family history of long-QT syndrome or sudden death without a preceding diagnosis of a condition that could be causative of sudden death (such as known coronary artery disease, congestive heart failure, or terminal cancer).
  • If assigned to the fasted/fed cohort, is lactose intolerant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Worldwide Clinical Trials

San Antonio, Texas, 78217, United States

Location

Related Publications (1)

  • Lombardi A, Pappas F, Nedelman J, Hickman D, Jaw-Tsai S, Olugbosi M, Bruinenberg P, Beumont M, Sun E. Pharmacokinetics and safety of TBAJ-876, a novel antimycobacterial diarylquinoline, in healthy subjects. Antimicrob Agents Chemother. 2024 Oct 8;68(10):e0061324. doi: 10.1128/aac.00613-24. Epub 2024 Aug 28.

    PMID: 39194204RESULT

MeSH Terms

Conditions

Lung DiseasesTuberculosis, PulmonaryTuberculosisTuberculosis, Multidrug-Resistant

Interventions

TBAJ-876Tablets

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract Infections

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Officials

  • Antonio Lombardi, MD

    Global Alliance for TB Drug Development

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2020

First Posted

July 30, 2020

Study Start

June 8, 2020

Primary Completion

June 16, 2022

Study Completion

November 15, 2022

Last Updated

June 4, 2025

Record last verified: 2025-05

Locations

US(1)