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
This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study of SYH2070 injection when administered subcutaneously to healthy subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYH2070 experimental group | Experimental | Subjects in experimental groups will receive a single subcutaneous injection of SYH2070 injection on Day 1. |
|
| Placebo group | Placebo Comparator | Subjects in placebo groups will receive a single subcutaneous injection of placebo on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYH2070 injection | Drug | subcutaneous injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects with Adverse Events as Assessed by CTCAE v5.0 | Pre-dose and multiple time points no less than 85 days |
| Measure | Description | Time Frame |
|---|---|---|
| The serum TG level after dosing SYH2070 injection | Pre-dose and multiple timepoints no less than 85 days | |
| The serum LDL-C level after dosing SYH2070 injection | Pre-dose and multiple timepoints no less than 85 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 | +86-0311-69085587 | ctr-contact@cspc.cn | |
| Yang Lin | Contact | 18910778667 | linyang@anzhengcp.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials Information Group | Recruiting | Shijiazhuang | Hebei | China |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
subcutaneous injection |
|
| Plasma Maximum concentration (Cmax) | Pre-dose and multiple timepoints up to 4 days |
| Time to maximum concentration (Tmax) | Pre-dose and multiple timepoints up to 4 days |
| Area under the concentration-time curve from 0 to the collection time t (AUC0-t) | Pre-dose and multiple timepoints up to 4 days |
| Half-Life (t1/2) | Pre-dose and multiple timepoints up to 4 days |
| Area under the concentration-time curve from 0 to infinity (AUC0-∞) | Pre-dose and multiple timepoints up to 4 days |