drugset / Trial / NCT04795037
First-In-Human Study of CU06-1004 Following Single and Multiple Ascending Doses in Healthy Volunteers
RandomizedSequentialQuadruple-blindTreatment
Summary
This clinical trial is the first-in-human study of CU06-1004. The purpose of this phase 1 study is to assess the safety and tolerability of single and multiple ascending oral doses of CU06-1004 in healthy adult subjects.
Timeline
- Start
- 2021-07-15
- Primary completion
- 2022-03-02
- Completion
- 2022-06-25
Publications
- Background Maganti L, Panebianco DL, Maes AL. Evaluation of methods for estimating time to steady state with examples from phase 1 studies. AAPS J. 2008;10(1):141-7. doi: 10.1208/s12248-008-9014-y. Epub 2008 Feb 28.
- Background Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CU06-1004 | Unknown | 100 mg | Oral |
| Subject | CU06-1004 | Unknown | 300 mg | Oral |
| Subject | CU06-1004 | Unknown | 600 mg | Oral |
| Subject | CU06-1004 | Unknown | 900 mg | Oral |
| Subject | CU06-1004 | Unknown | 1200 mg | Oral |