Actively Recruiting
A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Immunogenicity of STSP-0902 in Healthy Male Subjects
Led by Staidson (Beijing) Biopharmaceuticals Co., Ltd · Updated on 2026-05-22
64
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating STSP-0902, a drug being studied for safety, tolerability, pharmacokinetics, and immunogenicity in healthy male volunteers aged 18 to 50 years. This Phase 1b, randomized, double-blind, placebo-controlled study includes single and multiple ascending dose phases to better understand the drug's effects and behavior in the body. Participants will be assigned to one of several groups receiving different doses of STSP-0902 or a dose-matched placebo via subcutaneous injection. The study has multiple cohorts, including low, middle, high, and two higher-dose groups, with doses administered on Day 1 according to protocol requirements. The trial includes both single and multiple dose phases, with safety and immune responses monitored over time. Throughout the study, participants will undergo various assessments including monitoring of treatment-related adverse events, pharmacokinetic measurements such as drug concentration and clearance, and immunogenicity tests. These evaluations occur over an observation period extending up to 85 days in the multiple dose phase and 28 days in the single dose phase. Safety, tolerability, and laboratory tests will be regularly performed to ensure participant safety and gather comprehensive data on the drug's effects.
CONDITIONS
Brief Title
A Study to Evaluate the Safety and Tolerability of Single and Multiple Dose of STSP-0902 in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male volunteers aged 18 to 50 years inclusive
- Body weight of at least 50.0 kg
- Body mass index (BMI) between 19.0 and 28.0 kg/m² inclusive
- For multiple dose phase, two semen analyses during screening showing sperm concentration less than 15 million and/or progressive motility less than 32%
- Use of effective non-drug contraceptive measures during the trial and for four months after administration
- No plans for pregnancy or sperm donation during the study period
- Avoidance of high temperature environments such as saunas, steam baths, hot baths, hot springs, and electric blankets during the trial
- Signed informed consent form before participation
You will not qualify if you...
- History of severe diseases affecting major body systems or reproductive disorders except oligoasthenzoospermia
- Planned or recent (within 3 months) treatment for oligoasthenzoospermia such as zinc sulfate or levocarnitine
- Treatment with nerve growth factor-like drugs within 3 months prior to screening
- Major surgery within 3 months prior to screening or planned during the trial
- Fever over 38°C within 1 month prior to screening
- Clinically significant abnormalities in physical exam, ECG, vital signs, or lab tests unrelated to oligoasthenzoospermia
- Allergies to study drug components or risk of allergy
- Positive tests for hepatitis B, hepatitis C, syphilis, or HIV
- Tattoos or skin conditions at injection site interfering with observation
- Smoking more than 5 cigarettes per day in the 3 months prior to screening
- Frequent alcohol use exceeding 2 units per day in the 6 months prior to screening or positive alcohol breath test
- Habitual consumption over 5 cups of caffeinated beverages daily in the 3 months prior to screening
- History of drug abuse within 1 year prior to screening or positive urine drug test
- Recent blood donation or transfusion exceeding specified amounts
- Participation in other clinical trials within 3 months prior to screening
- Vaccination within 1 month prior to screening or planned during study up to 2 months after
- Use of prescription, over-the-counter medications, or herbal remedies within 14 days prior to screening
- History of fear of needles or homophobia
- Any other factors judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 85 days in the multiple dose phase and 28 days in the single dose phase
Participants receive single or multiple doses of STSP-0902 or placebo as per cohort assignment.
1 administration visit and multiple follow-up visits up to 85 days depending on dose phase
Duration - Up to 56 days post last dose in multiple dose phase and 28 days post last dose in single dose phase
Participants are monitored post-treatment for safety, pharmacokinetics, and immunogenicity.
Multiple visits for assessments up to 56 days or 28 days depending on dose phase
Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
Research Team
B
Bi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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