Evaluate Safety, Tolerability, PK of TBAJ-876 in Healthy Adults (NCT04493671) | Clinical Trial Compass
CompletedPhase 1
Evaluate Safety, Tolerability, PK of TBAJ-876 in Healthy Adults
United States137 participantsStarted 2020-06-08
Plain-language 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
Who can participate
Age range19 Years – 50 Years
SexALL
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Inclusion criteria
✓. 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.
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).
What they're measuring
1
Number of Participants with Treatment-Related Adverse Events in Part 1, Single Ascending Dose
Timeframe: Day 1 to Day 28
2
Number of Participants with Treatment-Related Adverse Events in Part 2, Multiple Ascending Dose
Timeframe: Day 1 to Day 133
3
Number of Participants with Treatment-Related Adverse Events in Part 3, Relative Bioavailability Study