This is a Phase 1b, randomized, double-blind, placebo-controlled, single and multiple ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of STSP-0902
Male volunteers, aged between 18 and 50 years inclusive, with a body weight of at least 50.0 kg, and a body mass index (BMI) between 19.0 and 28.0 kg/m² inclusive.
Participants in the multiple dose phase must meet one of the following criteria: two routine semen analysis results during the screening period meet the criteria of sperm concentration of less than 15 million and/or percentage of progressively motility sperm of less than 32%.
Participants (including the partners of the participants) must use effective non-drug contraceptive measures during the trial period and for four months after the end of administration, and must not have plans for pregnancy or sperm donation.
Participants should avoid high temperature environments during the trial, including saunas, steam baths, hot baths, hot springs, and the use of electric blankets.
Participants with a history of severe diseases, including but not limited to conditions affecting the skeletal, neuropsychiatric, cardiovascular, hematologic, hepatic, renal, gastrointestinal, respiratory, metabolic, endocrine, immune, and reproductive systems (such as reproductive system infectious diseases, varicocele, reproductive tract obstruction, etc., except for oligoasthenzoospermia), as judged by the investigator, may endanger the safety of the participant or affect the study results.
Participants who have planned to receive treatments related to oligoasthenzoospermia, such as zinc sulfate, levocarnitine, escin, or pancreatic kallikrein, within 3 months prior to screening or during the trial period.
Participants with a history of treatment with nerve growth factor-like drug therapy (such as mouse nerve growth factor for injection) within 3 months prior to screening.
Participants who have undergone any major surgery within 3 months prior to screening or have surgery planned during the trial period.
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Treatment groupsSee each treatment group below.