Actively Recruiting
A Clinical Study of GenSci134 in Healthy Adults and Adult Growth Hormone Deficiency(AGHD)
Led by Changchun GeneScience Pharmaceutical Co., Ltd. · Updated on 2026-04-14
64
Participants Needed
1
Research Sites
76 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Clinical Study of GenSci134 in Healthy Adults and Adult Growth Hormone Deficiency(AGHD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adult male subjects (Phase Ia) or healthy adult subjects (Phase Ib) aged 18-45 years (inclusive)
- Body Mass Index (BMI) between 19.0 and 24.0 kg/m8 (inclusive)
- Good health status
- Willing and able to understand and sign the informed consent form and follow study requirements
- AGHD patients (Phase Ic) aged 20 to 70 years (inclusive) at consent
- AGHD patients with BMI between 18.0 and 32.0 kg/m8 (inclusive)
- Diagnosed with growth hormone deficiency meeting specified clinical and test criteria
- No prior human growth hormone therapy or currently in washout period
- Willing and able to comply with study visits, treatments, and tests
You will not qualify if you...
- Significant medical history or clinical issues as determined by investigator
- History of allergies or hypersensitivity to drugs, compounds, foods, or study drug excipients
- History of neurological or psychiatric disorders, impaired consciousness, or cognitive dysfunction
- Clinically significant abnormal vital signs or lab results
- Immunodeficiency or immunosuppressive diseases
- Major surgery within 12 months prior to screening
- History of cancer
- Participation in other clinical trials with investigational products within 28 days or 5 half-lives prior to dosing
- Pregnant, breastfeeding, or not using effective contraception (for females)
- Male participants or partners not using effective contraception
- Clinically significant liver, kidney, or heart disease
- Use of investigational products or systemic corticosteroids within specified timeframes
- Conditions affecting safety or compliance as judged by investigator
- History of diabetes mellitus
- Active or recent malignancy
- Active Cushing's syndrome within 24 months prior to dosing
- Recent acute severe illness causing weight loss
- Use of weight-reducing drugs affecting body weight within 12 months prior
- Mental or language disorders impairing understanding or cooperation
- Anticipated lifestyle changes during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100083
Actively Recruiting
Research Team
D
Dongyang LIU, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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