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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-08

Study Completion Date

2022-11-15

Brief Summary

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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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Detailed Description

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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).

Conditions

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Pulmonary Disease Tuberculosis, Pulmonary Tuberculosis Multi Drug Resistant Tuberculosis Drug Sensitive Tuberculosis Drug-resistant Tuberculosis Mycobacterium Tuberculosis Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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TBAJ-876 10mg SAD

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

Group Type ACTIVE_COMPARATOR

TBAJ-876 suspension

Intervention Type DRUG

TBAJ-876 oral suspension, orally administered

TBAJ-876 25mg SAD

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

Group Type ACTIVE_COMPARATOR

TBAJ-876 suspension

Intervention Type DRUG

TBAJ-876 oral suspension, orally administered

TBAJ-876 50mg SAD

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

Group Type ACTIVE_COMPARATOR

TBAJ-876 suspension

Intervention Type DRUG

TBAJ-876 oral suspension, orally administered

TBAJ-876 100mg fasted SAD

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

Group Type ACTIVE_COMPARATOR

TBAJ-876 suspension

Intervention Type DRUG

TBAJ-876 oral suspension, orally administered

TBAJ-876 100mg fed SAD

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

Group Type ACTIVE_COMPARATOR

TBAJ-876 suspension

Intervention Type DRUG

TBAJ-876 oral suspension, orally administered

TBAJ-876 200mg SAD

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

Group Type ACTIVE_COMPARATOR

TBAJ-876 suspension

Intervention Type DRUG

TBAJ-876 oral suspension, orally administered

TBAJ-876 400mg SAD

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

Group Type ACTIVE_COMPARATOR

TBAJ-876 suspension

Intervention Type DRUG

TBAJ-876 oral suspension, orally administered

TBAJ-876 800mg SAD

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

Group Type ACTIVE_COMPARATOR

TBAJ-876 suspension

Intervention Type DRUG

TBAJ-876 oral suspension, orally administered

TBAJ-876 Placebo SAD

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

Group Type PLACEBO_COMPARATOR

Placebo suspension

Intervention Type DRUG

Placebo for TBAJ-876 oral Suspension; orally administered

TBAJ-876 25mg MAD

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

Group Type ACTIVE_COMPARATOR

TBAJ-876 suspension

Intervention Type DRUG

TBAJ-876 oral suspension, orally administered

TBAJ-876 75mg MAD

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

Group Type ACTIVE_COMPARATOR

TBAJ-876 suspension

Intervention Type DRUG

TBAJ-876 oral suspension, orally administered

TBAJ-876 200mg MAD

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

Group Type ACTIVE_COMPARATOR

TBAJ-876 suspension

Intervention Type DRUG

TBAJ-876 oral suspension, orally administered

TBAJ-876 Placebo MAD

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

Group Type PLACEBO_COMPARATOR

Placebo suspension

Intervention Type DRUG

Placebo for TBAJ-876 oral Suspension; orally administered

TBAJ-876 1x100 mg rBA fasted

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

Group Type ACTIVE_COMPARATOR

TBAJ-876 100 mg tablet

Intervention Type DRUG

TBAJ-876 100 mg tablets, orally administered

TBAJ-876 1x100 mg rBA fed

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

Group Type ACTIVE_COMPARATOR

TBAJ-876 100 mg tablet

Intervention Type DRUG

TBAJ-876 100 mg tablets, orally administered

TBAJ-876 4x25 mg rBA fasted

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

Group Type ACTIVE_COMPARATOR

TBAJ-876 25 mg tablet

Intervention Type DRUG

TBAJ-876 25 mg tablets, orally administered

Interventions

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TBAJ-876 suspension

TBAJ-876 oral suspension, orally administered

Intervention Type DRUG

Placebo suspension

Placebo for TBAJ-876 oral Suspension; orally administered

Intervention Type DRUG

TBAJ-876 100 mg tablet

TBAJ-876 100 mg tablets, orally administered

Intervention Type DRUG

TBAJ-876 25 mg tablet

TBAJ-876 25 mg tablets, orally administered

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

All volunteers must satisfy the following criteria to be considered for study participation:

1. Is a healthy adult male or female, 19 to 50 years of age (inclusive) at the time of screening.
2. Has a body mass index (BMI) ≥18.5 and ≤32.0 (kg/m2) and a body weight of no less than 50.0 kg.
3. 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.
4. Has not used tobacco- or nicotine-containing products (including smoking cessation products), for a minimum of 6 months before dosing.
5. 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.

Exclusion Criteria

1. 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.
2. Any presence of musculoskeletal toxicity (severe tenderness with marked impairment of activity, or frank necrosis).
3. Has a positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV at screening.
4. 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).
5. If assigned to the fasted/fed cohort, is lactose intolerant.

Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes