A Trial of CRB4101 in Healthy Subjects
Summary
The goal of this clinical trial is toevaluate the safety and tolerability of a single dose of CRB4101 tablets in healthy adults . The main questions it aims to answer are: * \[question 1\]The pharmacokinetics (PK) and pharmacodynamic dynamics (PD) characteristics of CRB4101 tablets were evaluated in healthy adults after a single administration. * \[question 2\]Exploratory analysis of the relationship between serum concentrations of CRB4101 (and its major metabolites, if necessary) and QTc interphase. * \[question 3\]Exploratory analysis of the metabolic and excretory characteristics of CRB4101 after a single administration (if necessary) * \[question 4\]Exploratory analysis of pharmacokinetic characteristics of major metabolites of CRB4101 (if necessary) * \[question 5\]The influence of pharmacogenomics on pharmacokinetic characteristics (if necessary). After the participants who signed the informed consent have been screened by the inclusion criteria, those who meet the inclusion criteria and those who do not meet the exclusion criteria will receive the following 6 dose groups in order from low to high: 100mg, 200 mg, 400 mg, 800 mg, 1200 mg, 1600 mg
Timeline
- Start
- 2022-11-16
- Primary completion
- 2023-04-05
- Completion
- 2023-06-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CRB4101 | Unknown | 100 mg | Oral |
| Subject | CRB4101 | Unknown | 200 mg | Oral |
| Subject | CRB4101 | Unknown | 400 mg | Oral |
| Subject | CRB4101 | Unknown | 800 mg | Oral |
| Subject | CRB4101 | Unknown | 1200 mg | Oral |
| Subject | CRB4101 | Unknown | 1600 mg | Oral |
Indications
No indication recorded.