drugset / Trial / NCT04104399
Single Ascending Dose Study to Investigate the Safety and Pharmacokinetics of XC101-D13H in Healthy Adult Subjects
RandomizedSequentialQuadruple-blindTreatment
Summary
This is a randomized, double-blind, placebo-controlled, parallel-group single ascending dose (SAD) study. There are 4 cohorts of 8 subjects (8 active and 2 placebo) planned for evaluation under fasting conditions. One of the planned dose levels will cross over after a washout period to receive the same single dose of XC101-D13H or placebo under fed conditions.
Timeline
- Start
- 2019-10-08
- Primary completion
- 2022-01-28
- Completion
- 2022-03-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | XC101-D13H | Unknown | 0.4 mg | — |
| Subject | XC101-D13H | Unknown | 0.8 mg | — |
| Subject | XC101-D13H | Unknown | 1.6 mg | — |
| Subject | XC101-D13H | Unknown | 3.2 mg | — |