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
To check how safe and well-tolerated a single subcutaneous injection of GenSc134 is in healthy male volunteers, a multiple-doses subcutaneous injection of GenSc134 is in healthy volunteers,a single subcutaneous injection of GenSc134 is in AGHD patients.
This study consists of two parts: the first part is the study in healthy volunteers, and the second part is the study in AGHD patients.
The first part consists of two phases. Phase Ia is a single-ascending dose study in healthy male volunteers, and Phase Ib is a multiple-ascending dose study healthy male or female volunteers.
The second part is Phase Ic,which is a a single-ascending dose study in AGHD patients.
Phase Ia:GenSci134 was tested in 7 predetermined single dose groups with placebo and positive drug controls to explore the dosage, and to assess its safety, tolerability, pharmacokinetic (PK) characteristics, pharmacodynamic (PD) characteristics, immunogenicity, and exploratory endpoints in 64 healthy adult male volunteers.
Phase Ib:GenSci134 was tested in 3 predetermined multiple dose groups with placebo, and to assess its safety, tolerability, pharmacokinetic (PK) characteristics, pharmacodynamic (PD) characteristics, immunogenicity in 36 healthy adult volunteers.
Phase Ic :GenSci134 was tested in 2 predetermined dose groups with positive drug controls to explore the dosage, and to assess its safety, tolerability, pharmacokinetic (PK) characteristics, pharmacodynamic (PD) characteristics, immunogenicity, and exploratory endpoints in 16 AGHD patients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GenSci134 | Experimental |
| |
| GenSc134 Placebo | Placebo Comparator |
| |
| Recombinant Human Growth Hormone Injection (Norditropin®) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GenSci134 | Drug | only one dose of GenSci134 to be given, subcutaneous , 7 dose level groups will be assigned. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events and serious adverse events | From Day 0 to Month 3 |
Not provided
Not provided
Inclusion Criteria:
The first part in Healthy adult volunteers:
The second part in AGHD patients(Phase Ic):
Exclusion Criteria:
The first part in Healthy adult volunteers:
The second part in AGHD patients(Phase Ic):
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dongyang LIU, PHD | Contact | +86 18610966092 | liudongyang@vip.sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Dongyang LIU, PHD | Peking University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100083 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | only one dose of GenSci134 Placebo to be given, subcutaneous , 7 dose level groups will be assigned. |
|
| Recombinant Human Growth Hormone Injection (Norditropin®) | Drug | A single dose of 0.2 mg/day, administered once daily (QD) for 28 consecutive days. |
|
| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001849 | Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D019382 | Human Growth Hormone |
| ID | Term |
|---|---|
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided