A Phase I, Randomized, Double-blind, Placebo and Active-controlled Study of Single and Multiple Ascending Doses of GenSci134 Injection in Healthy Adults, and a Single Ascending Dose in Patients With Adult Growth Hormone Deficiency
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.
⁃ The first part in Healthy adult volunteers:
• Healthy adult male subjects（Phase Ia），or Healthy adult subjects（Phase Ib） aged 18-45 years (inclusive of boundary values);
• Body Mass Index (BMI): 19.0-24.0 kg/m² (inclusive of boundary values);
• Good health status;
• Able to understand and willing to sign the Informed Consent Form (ICF), and comply with study requirements and restrictions.
⁃ The second part in AGHD patients（Phase Ic）:
• Be able to understand and be willing to sign the written ICF (before any study procedure is performed).
• Be willing and able to comply with scheduled visits, treatment regimens, laboratory tests, and other specified study procedures.
• Aged from 20 to 70 years old (inclusive), at the time of signing the ICF.
• Body mass index (BMI): 18.0-32.0 kg/m² ((inclusive of boundary values).
• Meeting any of the following diagnostic criteria for growth hormone deficiency:
• Adult-onset: Participants with GHD due to hypothalamo-pituitary disorder or relevant treatments (surgery, radiotherapy) or other reasons (infection, traumatic craniocerebral injury, etc.); the participant has no relapse or residual disease is stable for more than 1 year after surgery for pituitary adenoma, surgery for craniopharyngioma or other pituitary gland operation.
• Childhood-onset: Participants with childhood idiopathic, acquired, congenital GHD or childhood GHD for other reasons.
• Confirmed diagnosis of AGHD (meeting at least one of the following criteria):
• Insulin tolerance test: peak GH cut-off point ≤ 5 μg/L.
• Glucagon challenge test:
• a) Participants with BMI \< 25 kg/m² or high clinical suspicion \[≥ 3 pituitary hormone deficiencies (PHDs)\] with BMI 25-30 kg/m², peak GH ≤ 3 μg/L.
• b) Participants with BMI \> 30 kg/m² or low clinical suspicion (≤ 2 PHDs) with BMI 25-30 kg/m², peak GH ≤ 1 μg/L.
• ≥ 3 PHDs and IGF-1 SDS \< -2.0 at screening.
• Participants who have not previously received human growth hormone (hGH) therapy or are in the washout period of previous hGH therapy.