A Phase 1a, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Immunogenicity of STSP-0902 in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- STSP-0902 injection
- Conditions
- Oligozoospermia
- Sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Number of treatment-related adverse events as assessed by CTCAE 5.0
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
This is a Phase 1a, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of STSP-0902.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy 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, and whose routine semen analysis results during the screening period meet the criteria of a total sperm count of less than 180 million (or a sperm concentration of less than 63 million) or a percentage of progressively motility sperm of less than 56%.
- •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.
- •Subjects must give informed consent to this study before the study and voluntarily sign a written informed consent form.
Exclusion Criteria
- •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.
- •Subjects who have undergone any major surgery within 3 months prior to screening or have surgery planned during the trial period.
- •Pre-enrollment physical examination, electrocardiogram, vital signs, laboratory tests, and results of all tests related to the trial (except oligoasthenzoospermia), with abnormalities judged clinically significant by the investigator.
- •Subjects who are allergic to any component of the experimental drug or biological agent, or who, in the judgment of the investigator, are at risk of allergy as a result of participation in the study.
- •Subjects who are positive for any one of the hepatitis B surface antigen, hepatitis C antibody, treponema pallidum antibody, and HIV antigen/antibody combination test (primary screening).
- •Tattoos at the injection site or other skin conditions that interfere with observation of the skin.
- •Subjects who have smoked more than 5 cigarettes per day or an equivalent amount of tobacco in the 3 months prior to screening.
- •Subjects with frequent alcohol consumption within 6 months prior to screening, i.e., more than 2 units of alcohol per day (1 unit = 360 ml of beer or 45 ml of spirits of 40% alcohol by volume or 150 ml of wine); or those with a positive alcohol breath test.
Arms & Interventions
lowest dose group
8 subjects will be randomized to receive lowest dose of STSP-0902 subcutaneous injection or dose-matched placebo (First cohort)
Intervention: STSP-0902 injection
lowest dose group
8 subjects will be randomized to receive lowest dose of STSP-0902 subcutaneous injection or dose-matched placebo (First cohort)
Intervention: Placebo
low dose group
8 subjects will be randomized to receive low dose of STSP-0902 subcutaneous injection or dose-matched placebo (Second cohort)
Intervention: STSP-0902 injection
low dose group
8 subjects will be randomized to receive low dose of STSP-0902 subcutaneous injection or dose-matched placebo (Second cohort)
Intervention: Placebo
middle dose group
8 subjects will be randomized to receive middle dose of STSP-0902 subcutaneous injection or dose-matched placebo (Third cohort)
Intervention: STSP-0902 injection
middle dose group
8 subjects will be randomized to receive middle dose of STSP-0902 subcutaneous injection or dose-matched placebo (Third cohort)
Intervention: Placebo
high dose group
Experimental: 8 subjects will be randomized to receive high dose of STSP-0902 subcutaneous injection or dose-matched placebo (Fourth cohort)
Intervention: STSP-0902 injection
high dose group
Experimental: 8 subjects will be randomized to receive high dose of STSP-0902 subcutaneous injection or dose-matched placebo (Fourth cohort)
Intervention: Placebo
highest dose group
Experimental: 8 subjects will be randomized to receive highest dose of STSP-0902 subcutaneous injection or dose-matched placebo (Fifth cohort)
Intervention: STSP-0902 injection
highest dose group
Experimental: 8 subjects will be randomized to receive highest dose of STSP-0902 subcutaneous injection or dose-matched placebo (Fifth cohort)
Intervention: Placebo
Outcomes
Primary Outcomes
Number of treatment-related adverse events as assessed by CTCAE 5.0
Time Frame: 28 days
To evaluate the safety and tolerability of STSP-0902 injection in healthy adult subjects
Secondary Outcomes
- apparent oral clearance (CL/F)(Pre-dose; after dose: 2 hours, 6 hours, 10 hours, 14 hours, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 336 hours, 28 days)
- Elimination Phase Half-life (t1/2)(Pre-dose; after dose: 2 hours, 6 hours, 10 hours, 14 hours, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 336 hours, 28 days)
- Anti-drug antibody(ADA)(Pre-dose; after dose: 336 hours, 28 days)
- Area under the curve from time 0 extrapolated to infinite time (AUC0-∞)(Pre-dose; after dose: 2 hours, 6 hours, 10 hours, 14 hours, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 336 hours, 28 days)
- Maximum Concentration (Cmax)(Pre-dose; after dose: 2 hours, 6 hours, 10 hours, 14 hours, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 336 hours, 28 days)
- Area under the plasma concentration-time curve (AUC0-t)(Pre-dose; after dose: 2 hours, 6 hours, 10 hours, 14 hours, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 336 hours, 28 days)
- Time to peak Concentration (Tmax)(Pre-dose; after dose: 2 hours, 6 hours, 10 hours, 14 hours, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 336 hours, 28 days)