drugset / Trial / NCT03110549
Study of the Safety, Tolerability and Pharmacokinetics of TMB-607 in HIV-Negative Volunteers
RandomizedSequentialTriple-blindTreatment
Summary
The study is a Phase 1, randomized, double-blinded, placebo-controlled, sequential single dose escalation safety, tolerability and pharmacokinetic study of subcutaneous and intramuscular TMB-607 administered to HIV-negative volunteers.
Timeline
- Start
- 2016-11-21
- Primary completion
- 2019-07-22
- Completion
- 2019-07-22
Outcome
Outcome not reported
Stopped: “Drug development suspended by current holder of IND”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TMB-607 | Small molecule | 100 mg | Subcutaneous |
| Subject | TMB-607 | Small molecule | 200 mg | Subcutaneous |
| Subject | TMB-607 | Small molecule | 400 mg | Subcutaneous |
| Subject | TMB-607 | Small molecule | 500 mg | Subcutaneous |
| Subject | TMB-607 | Small molecule | 800 mg | Subcutaneous |
| Subject | TMB-607 | Small molecule | 1000 mg | Subcutaneous |
| Subject | TMB-607 | Small molecule | 1500 mg | Subcutaneous |