Status:
COMPLETED
Evaluate Safety, Tolerability, PK of TBAJ-876 in Healthy Adults
Lead Sponsor:
Global Alliance for TB Drug Development
Conditions:
Pulmonary Disease
Tuberculosis, Pulmonary
Eligibility:
All Genders
19-50 years
Phase:
PHASE1
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 Bioavailabilit...
Detailed Description
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 cond...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
June 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2022
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT04493671
Start Date
June 8 2020
End Date
November 15 2022
Last Update
June 4 2025
Active Locations (1)
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1
Worldwide Clinical Trials
San Antonio, Texas, United States, 78217