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A Study to Evaluate the Safety and Tolerability of Single and Multiple Dose of STSP-0902 in Healthy Subjects

ConditionOligozoospermia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-50
SponsorStaidson (Beijing) Biopharmaceuticals Co., Ltd

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • STSP-0902 injection

    Drug

    Subjects will receive the administration dose on Day 1 following protocol requirements

  • Placebo

    Drug

    Subjects will receive the administration dose on Day 1 following protocol requirements

Treatment groups

64 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: low dose of STSP-0902 subcutaneous injection or dose-matched placebo (First cohort)Experimental treatment 2 interventions
Group B: middle dose of STSP-0902 subcutaneous injection or dose-matched placebo (Second cohort)Experimental treatment 2 interventions
Group C: high dose of STSP-0902 subcutaneous injection or dose-matched placebo (Third cohort)Experimental treatment 2 interventions
Group D: higher dose of STSP-0902 subcutaneous injection or dose-matched placebo (fourth cohort)Experimental treatment 2 interventions
Group E: Higher dose Ⅰ of STSP-0902 sc injection or dose-matched placebo (First cohort in single dose phase)Experimental treatment 2 interventions
Group F: Higher dose Ⅱ of STSP-0902 sc injection or dose-matched placebo (Second cohort in single dose phase)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of treatment-related adverse events as assessed by CTCAE 5.0.

To evaluate the safety and tolerability of STSP-0902 injection in healthy adult subjects

Time frame
85 days in multiple dose phase and 28 days in single dose phase

Secondary outcomes

1

Maximum Concentration (Cmax)

To evaluate the pharmacokinetics (PK) of STSP-0902

Time frame
From pre-dose up to 21 days post last dose
2

Area under the plasma concentration-time curve (AUC0-t)

To evaluate the pharmacokinetics (PK) of STSP-0902

Time frame
From pre-dose up to 21 days post last dose
3

Area under the curve from time 0 extrapolated to infinite time (AUC0-∞)

To evaluate the pharmacokinetics (PK) of STSP-0902

Time frame
From pre-dose up to 21 days post last dose
4

Time to peak Concentration (Tmax)

To evaluate the pharmacokinetics (PK) of STSP-0902

Time frame
From pre-dose up to 21 days post last dose

Other outcomes

1

Tests for hormones

Time frame
85 days in multiple dose phase and 28 days in single dose phase

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Staidson (Beijing) Biopharmaceuticals Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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