A Clinical Study of GenSci134 in Healthy Adults and Adult Growth Hormone Deficiency(AGHD) (NCT07016802) | Clinical Trial Compass
RecruitingPhase 1
A Clinical Study of GenSci134 in Healthy Adults and Adult Growth Hormone Deficiency(AGHD)
China64 participantsStarted 2025-06-09
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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 criteri…
What they're measuring
1
Incidence and severity of adverse events and serious adverse events