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Completed

NCT Number: NCT04493671

Evaluate Safety, Tolerability, PK of TBAJ-876 in Healthy Adults

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

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Key information

Conditions

Pulmonary Disease Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Drug Sensitive Tuberculosis Drug-resistant Tuberculosis Gram-Positive Bacterial Infections Infections Lung Diseases Multi Drug Resistant Tuberculosis Mycobacterium Infections Mycobacterium Tuberculosis Infection Respiratory Tract Diseases Respiratory Tract Infections Tuberculosis Tuberculosis, Multidrug-Resistant Tuberculosis, Pulmonary

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Worldwide Clinical Trials

San Antonio, Texas, 78217, United States

About this study

This study is a three-part, partially blinded, placebo controlled, combined single ascending dose with food-effect, multiple ascending dose study, and a single dose relative bioavailability study conducted at one study center in the United States.

Safety will be assessed throughout the study for all subjects. Safety assessments will include physical examinations, vital signs, serial ECGs, cardiac monitoring, adverse events (AEs), and clinical laboratory tests (including hematology, serum chemistry, coagulation, and urinalysis).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

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.

Key Exclusion Criteria:

  • 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.

Treatment and study plan

TBAJ-876 suspension

Drug

TBAJ-876 oral suspension, orally administered

Placebo Suspension

Drug

Placebo for TBAJ-876 oral Suspension; orally administered

TBAJ-876 100 mg tablet

Drug

TBAJ-876 100 mg tablets, orally administered

TBAJ-876 25 mg tablet

Drug

TBAJ-876 25 mg tablets, orally administered

Primary outcomes

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

    Time frame: Day 1 to Day 28

    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.

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

    Time frame: Day 1 to Day 133

    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.

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

    Time frame: Day 1 to Day 21

    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.

Secondary outcomes

  1. AUCExtrap [Pharmacokinetic Analysis]

    Time frame: Days 1 - 28

    PK parameters will be calculated from plasma concentrations of TBAJ-876 TBAJ-876, M2, and M3. AUCExtrap is the percentage of AUCinf based on extrapolation.

  2. AUCinf [Pharmacokinetic Analysis]

    Time frame: Days 1 - 28

    PK parameters will be calculated from plasma concentrations of TBAJ-876 TBAJ-876, M2, and M3. AUCinf is area under the concentration-time curve from time-zero extrapolated to infinity.

  3. AUClast [Pharmacokinetic Analysis]

    Time frame: Days 1 - 28

    PK parameters will be calculated from plasma concentrations of TBAJ-876 TBAJ-876, M2, and M3. AUClast area under the concentration-time curve from time-zero to the time of the last quantifiable concentration; calculated using the linear trapezoidal rule.

  4. AUCtau [Pharmacokinetic Analysis]

    Time frame: Days 1 - 28

    PK parameters will be calculated from plasma concentrations of TBAJ-876 TBAJ-876, M2, and M3. AUCtau is area under the concentration-time curve during the dosing interval; calculated using the linear trapezoidal rule.

  5. Cavg [Pharmacokinetic Analysis]

    Time frame: Days 1 - 28

    PK parameters will be calculated from plasma concentrations of TBAJ-876 TBAJ-876, M2, and M3. Cavg is average concentration during the dosing interval.

  6. Clast [Pharmacokinetic Analysis]

    Time frame: Days 1 - 28

    PK parameters will be calculated from plasma concentrations of TBAJ-876 TBAJ-876, M2, and M3. Clast is the last quantifiable concentration determined directly from individual concentration-time data.

  7. CL/F [Pharmacokinetic Analysis]

    Time frame: Days 1 - 28

    PK parameters will be calculated from plasma concentrations of TBAJ-876 TBAJ-876, M2, and M3. CL/F is apparent total clearance after single administration.

  8. CLss/F [Pharmacokinetic Analysis]

    Time frame: Days 1 - 28

    PK parameters will be calculated from plasma concentrations of TBAJ-876 TBAJ-876, M2, and M3. CLss/F is apparent total clearance after multiple administration.

  9. Cmax [Pharmacokinetic Analysis]

    Time frame: Days 1 - 28

    PK parameters will be calculated from plasma concentrations of TBAJ-876 TBAJ-876, M2, and M3. Cmax is maximum concentration, determined directly from individual concentration-time data.

  10. RAUC [Pharmacokinetic Analysis]

    Time frame: Days 1 - 28

    PK parameters will be calculated from plasma concentrations of TBAJ-876 TBAJ-876, M2, and M3. RAUC is accumulation factor during multiple dosing, based on AUCtau.

  11. RCmax [Pharmacokinetic Analysis]

    Time frame: Days 1 - 28

    PK parameters will be calculated from plasma concentrations of TBAJ-876 TBAJ-876, M2, and M3. RCmax is accumulation factor during multiple dosing, based on Cmax.

  12. Tlast [Pharmacokinetic Analysis]

    Time frame: Days 1 - 28

    PK parameters will be calculated from plasma concentrations of TBAJ-876 TBAJ-876, M2, and M3. Tlast is time of the last quantifiable concentration.

  13. Tmax [Pharmacokinetic Analysis]

    Time frame: Days 1 - 28

    PK parameters will be calculated from plasma concentrations of TBAJ-876 TBAJ-876, M2, and M3. Tmax is time of the maximum concentration.

  14. T1/2 [Pharmacokinetic Analysis]

    Time frame: Days 1 - 28

    PK parameters will be calculated from plasma concentrations of TBAJ-876 TBAJ-876, M2, and M3. T1/2 is the observed terminal half-life.

  15. Vz/F [Pharmacokinetic Analysis]

    Time frame: Days 1 - 28

    PK parameters will be calculated from plasma concentrations of TBAJ-876 TBAJ-876, M2, and M3. Vz/F is apparent volume of distribution in the terminal phase.

  16. λz [Pharmacokinetic Analysis]

    Time frame: Days 1 - 28

    PK parameters will be calculated from plasma concentrations of TBAJ-876 TBAJ-876, M2, and M3. λz is the observed terminal rate constant; estimated by linear regression through at least 3 data points in the terminal phase of the log concentration-time profile.

Sponsors and collaborators

Lead sponsor

Global Alliance for TB Drug Development

Other

Registry information

Official study title

A Phase 1, Partially Blind, Placebo Controlled, Randomized, Combined Single Ascending Dose With a Food Effect Cohort, Multiple Ascending Dose, and Relative Bioavailability Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBAJ-876 in Healthy Adult Subjects

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 30, 2020
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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