This is a multiple-dose, dose-escalation, randomized, double-blind, placebo-controlled phase Ⅱa clinical trial. A total of 36 adult participants with growth hormone deficiency will be enrolled sequentially in ascending dose cohorts, and within each dose cohort, participants will be randomized in a 3:1 ratio.
Male study participants aged ≥ 18 years and < 80 years at the time of signing the informed consent form (ICF);
No systemic treatment with growth hormone or growth hormone secretagogues within 6 months prior to entering the screening period;
For patients with any other pituitary hormone deficiency who are on hormone replacement therapy (HRT) at screening, HRT must have been stable for at least 3 months;
Study participants must agree to use reliable contraceptive measures with their spouses from - Study participants fully understand the purpose, nature, methods and potential adverse reactions of the trial, voluntarily participate in the study, and have signed the informed consent form.
Individuals with known or suspected hypersensitivity to the investigational product or its excipients;
Patients with severe malnutrition as judged by the investigator, or with a BMI < 18.5 kg/m² at screening;
Patients with active malignancy or a history of malignancy; or with thyroid nodules classified as TI-RADS grade ≥ 4a on thyroid ultrasound; or with high-risk or suspected malignant nodules detected on chest CT; or with clinically significant abnormal tumor markers at screening;
Surgical resection of pituitary adenoma or other benign intracranial tumors within 12 months prior to screening;
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Treatment groupsSee each treatment group below.