drugset / Trial / NCT03078738
Safety and Pharmacokinetic Study of OMT-28 in Healthy Subjects
RandomizedSequentialTriple-blindTreatment
Summary
The aim of this first-in-human study is to assess the safety, tolerability, PK and exploratory pharmacodynamics (PD) of single and multiple oral ascending doses of OMT-28 in healthy male subjects to support further clinical development of OMT-28 in the indication of atrial fibrillation (AF) and to obtain data on food and gender effects of OMT-28 to guide dosing for Phase II trials.
Timeline
- Start
- 2017-02-08
- Primary completion
- 2018-03-12
- Completion
- 2018-03-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | OMT-28 | Small molecule | 4 mg | Oral |
| Subject | OMT-28 | Small molecule | 12 mg | Oral |
| Subject | OMT-28 | Small molecule | 15 mg | Oral |
| Subject | OMT-28 | Small molecule | 30 mg | Oral |
| Subject | OMT-28 | Small molecule | 36 mg | Oral |
| Subject | OMT-28 | Small molecule | 60 mg | Oral |
Indications
No indication recorded.