Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Peking Union Medical College Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is aimed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics of a single-dose of Pegylated-Somatropin in healthy male volunteers, and collect scientific data for the design and conduct of subsequent studies.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pegylated-Somatropin, 10mcg/kg | Experimental |
| |
| Pegylated-Somatropin, 30mcg/kg | Experimental |
| |
| Pegylated-Somatropin, 60mcg/kg | Experimental |
| |
| Pegylated-Somatropin, 120mcg/kg | Experimental |
| |
| Pegylated-Somatropin, 200mcg/kg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated-Somatropin | Drug | Daily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-Somatropin, 10mcg/kg. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of the IGF-1 levels for pharmacodynamics study | baseline, one week after initiation of the control drug and two weeks after initiation of the study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Measuring the drug levels in blood samples | baseline, one week after initiation of the control drug and two weeks after initiation of the study drug | |
| Measurement of IGFBP-3 levels for pharmacodynamic study | baseline, one week after initiation of the control drug and two weeks after initiation of the study drug |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hu Pei, Ph.D | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100032 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| YPEG-Somatropin | Drug | Daily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-somatropin, 30mcg/kg. |
|
| YPEG-Somatropin | Drug | Daily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-somatropin, 60mcg/kg. |
|
| YPEG-Somatropin | Drug | Daily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-somatropin, 120mcg/kg. |
|
| YPEG-Somatropin | Drug | Daily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-somatropin, 200mcg/kg. |
|