Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Randomized, double-blind and placebo-controlled study to assess the safety, tolerability and pharmacokinetics of single ascending doses of SYH2085 and its food effect in China healthy adult participants. The study is composed of 2 parts. Part 1 is to assess the safety, tolerability and pharmacokinetics of a single ascending dose of SYH2085 tablet. Part 2 is to assess the food effect on SYH2085 at a selected dose in a cross-over design.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYH2085 SAD experimental group | Experimental | Participants in SAD experimental groups will receive a single oral administration of SYH2085 tablet on Day 1. |
|
| Placebo SAD group | Placebo Comparator | Participants in SAD experimental groups will receive a single oral administration of placebo on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYH2085 | Drug | oral administration |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of adverse events (AEs) | Pre-dose and multiple timepoints no less than 22 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve (AUC) | Pre-dose and multiple timepoints no less than 22 days | |
| Plasma Maximum concentration (Cmax) | Pre-dose and multiple timepoints no less than 22 days | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Information Group officer | Contact | 031169085587 | ctr-contact@cspc.cn | |
| Xiaojie Wu | Contact | 86-13524686330 | maomao_xj@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital Fudan University | Recruiting | Shanghai | Shanghai Municipality | China |
Not provided
Drug: SYH2085 Other: Placebo
Not provided
Not provided
Not provided
| Drug |
oral administration |
|
| Half-Life (t1/2) |
| Pre-dose and multiple timepoints no less than 22 days |