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
To evaluate the safety and tolerability of GS3-007a oral solution after multiple oral administration in Chinese healthy adult subjects.
To evaluate the pharmacodynamic (PD) and pharmacokinetics(PK) characteristics of GS3-007a oral solution after multiple oral administration in Chinese healthy adult subjects
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GS3-007 oral liquid | Experimental | 36 subjects,12 subjects in each dose group. Two dose groups were planned: 0.8 mg/kg and 1.6 mg/kg once a day for 4 weeks. According to the research progress of 1.6mg/kg QD, it was decided whether to add 0.8 mg/kg twice a day for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS3-007 oral liquid | Drug | The dosage was calculated according to body weight, once a day or twice a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| TEAEs | 35 Days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chengdu Xinhua Hospital Affiliated to North Sichuan Medical College | Chengdu | Sichuan | 610000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided