Evaluate Safety, Tolerability, PK of TBAJ-876 in Healthy Adults
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Drug Sensitive Tuberculosis
- Drug-Resistant Tuberculosis
- Multi Drug Resistant Tuberculosis
- Mycobacterium Tuberculosis Infection
- Pulmonary Disease
- Tuberculosis
- Tuberculosis, Pulmonary
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 19 years and 50 years
- Gender
- Both males and females
Description
This study is a two-part, partially blinded, placebo controlled, combined single ascending dose (SAD) with food-effect and multiple ascending dose (MAD) study conducted in one study center in the United States. Safety will be assessed throughout the study for all subjects. Safety assessments will in...
This study is a two-part, partially blinded, placebo controlled, combined single ascending dose (SAD) with food-effect and multiple ascending dose (MAD) study conducted in 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).
Tracking Information
- NCT #
- NCT04493671
- Collaborators
- Not Provided
- Investigators
- Study Chair: Antonio Lombardi, MD Global Alliance for TB Drug Development
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