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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lowest dose group | Experimental | 8 subjects will be randomized to receive lowest dose of STSP-0902 subcutaneous injection or dose-matched placebo (First cohort) |
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| low dose group | Experimental | 8 subjects will be randomized to receive low dose of STSP-0902 subcutaneous injection or dose-matched placebo (Second cohort) |
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| middle dose group | Experimental | 8 subjects will be randomized to receive middle dose of STSP-0902 subcutaneous injection or dose-matched placebo (Third cohort) |
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| high dose group | Experimental | Experimental: 8 subjects will be randomized to receive high dose of STSP-0902 subcutaneous injection or dose-matched placebo (Fourth cohort) |
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| highest dose group | Experimental | Experimental: 8 subjects will be randomized to receive highest dose of STSP-0902 subcutaneous injection or dose-matched placebo (Fifth cohort) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STSP-0902 injection | Drug | Subjects will receive the administration dose on Day 0 following protocol requirements |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Concentration (Cmax) | To evaluate the pharmacokinetics (PK) of STSP-0902 | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kai Hong, Doctor | Peking University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China |
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| ID | Term |
|---|---|
| D009845 | Oligospermia |
| D053627 | Asthenozoospermia |
| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| Placebo | Drug | Subjects will receive the administration dose on Day 0 following protocol requirements |
|
To evaluate the pharmacokinetics (PK) of STSP-0902 |
| 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 curve from time 0 extrapolated to infinite time (AUC0-∞) | To evaluate the pharmacokinetics (PK) of STSP-0902 | 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) | To evaluate the pharmacokinetics (PK) of STSP-0902 | 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) | To evaluate the pharmacokinetics (PK) of STSP-0902 | 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 |
| apparent oral clearance (CL/F) | To evaluate the pharmacokinetics (PK) of STSP-0902 | 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) | To evaluate the immunogenicity of STSP-0902 | Pre-dose; after dose: 336 hours, 28 days |
| D007246 |
| Infertility |
| D052801 | Male Urogenital Diseases |