drugset / Trial / NCT04890535
Evaluation of the Safety, Tolerability, PK of TBAJ-587 in Healthy Adults
RandomizedParallel-groupTriple-blindTreatment
Summary
Phase 1, Partially Blinded, Placebo-Controlled, Randomized, Combined Single Ascending Dose with Food Effect Cohort Trial (Part 1) and Multiple Ascending Dose Trial (Part 2) to Evaluate the Safety, Tolerability, and PK of TBAJ-587 in Healthy Adults
Timeline
- Start
- 2020-12-01
- Primary completion
- 2023-02-27
- Completion
- 2023-02-27
Publications
- Leding AAM, Bruinenberg P, Conradie A, Nedelman J, Lombardi A, Hickman D, Simonsson USH. Population pharmacokinetics of TBAJ-587 and its main metabolites-Evaluation of different loading dose strategies and early dose selection. Br J Clin Pharmacol. 2026 Apr;92(4):1058-1068. doi: 10.1002/bcp.70333. Epub 2025 Nov 19.
- Komm OD, Tyagi S, Garcia A, Almeida D, Chang Y, Li S-Y, Castillo JR, Converse PJ, Black T, Fotouhi N, Nuermberger EL. Contribution of telacebec to novel drug regimens in a murine tuberculosis model. Antimicrob Agents Chemother. 2025 Jan 31;69(1):e0096224. doi: 10.1128/aac.00962-24. Epub 2024 Dec 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | TBAJ-587 | Small molecule | 25 mg | Oral |
| Comparator | TBAJ-587 | Small molecule | 50 mg | Oral |
| Comparator | TBAJ-587 | Small molecule | 100 mg | Oral |
| Comparator | TBAJ-587 | Small molecule | 200 mg | Oral |
| Comparator | TBAJ-587 | Small molecule | 400 mg | Oral |
| Comparator | TBAJ-587 | Small molecule | 800 mg | Oral |