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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low dose of STSP-0902 subcutaneous injection or dose-matched placebo (First cohort) | Experimental | 12 subjects will be randomized to receive lowest dose of STSP-0902 subcutaneous injection or dose-matched placebo (First cohort) |
|
| middle dose of STSP-0902 subcutaneous injection or dose-matched placebo (Second cohort) | Experimental | 12 subjects will be randomized to receive middle dose of STSP-0902 subcutaneous injection or dose-matched placebo (Second cohort) |
|
| high dose of STSP-0902 subcutaneous injection or dose-matched placebo (Third cohort) | Experimental | 12 subjects will be randomized to receive high dose of STSP-0902 subcutaneous injection or dose-matched placebo (Third cohort) |
|
| higher dose of STSP-0902 subcutaneous injection or dose-matched placebo (fourth cohort) | Experimental | 12 subjects will be randomized to receive high dose of STSP-0902 subcutaneous injection or dose-matched placebo (fourth cohort) |
|
| Higher dose Ⅰ of STSP-0902 sc injection or dose-matched placebo (First cohort in single dose phase) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STSP-0902 injection | Drug | Subjects will receive the administration dose on Day 1 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 | 85 days in multiple dose phase and 28 days in single dose phase |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Concentration (Cmax) | To evaluate the pharmacokinetics (PK) of STSP-0902 | From pre-dose up to 21 days post last dose |
| Area under the plasma concentration-time curve (AUC0-t) | To evaluate the pharmacokinetics (PK) of STSP-0902 |
| Measure | Description | Time Frame |
|---|---|---|
| Tests for hormones | 85 days in multiple dose phase and 28 days in single dose phase |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bi | Contact | +8613130207522 | bicui@staidson.com |
| Name | Affiliation | Role |
|---|---|---|
| Kai Hong, Ph.D | Peking University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100191 | China |
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| ID | Term |
|---|---|
| D009845 | Oligospermia |
| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| Experimental |
8 subjects will be randomized to receive high dose Ⅰ of STSP-0902 subcutaneous injection or dose-matched placebo (First cohort in single dose phase) |
|
| Higher dose Ⅱ of STSP-0902 sc injection or dose-matched placebo (Second cohort in single dose phase) | Experimental | 8 subjects will be randomized to receive high dose Ⅱ of STSP-0902 subcutaneous injection or dose-matched placebo (Second cohort in single dose phase) |
|
| Placebo | Drug | Subjects will receive the administration dose on Day 1 following protocol requirements |
|
| From pre-dose up to 21 days post last dose |
| Area under the curve from time 0 extrapolated to infinite time (AUC0-∞) | To evaluate the pharmacokinetics (PK) of STSP-0902 | From pre-dose up to 21 days post last dose |
| Time to peak Concentration (Tmax) | To evaluate the pharmacokinetics (PK) of STSP-0902 | From pre-dose up to 21 days post last dose |
| Elimination Phase Half-life (t1/2) | To evaluate the pharmacokinetics (PK) of STSP-0902 | From pre-dose up to 21 days post last dose |
| apparent oral clearance (CL/F) | To evaluate the pharmacokinetics (PK) of STSP-0902 | From pre-dose up to 21 days post last dose in multiple dose phase and 28 days in single dose phase. |
| Anti-drug antibody(ADA) | To evaluate the immunogenicity of STSP-0902 | From pre-dose up to 56 days post last dose in multiple dose phase and 28 days in single dose phase |
| D007246 |
| Infertility |
| D052801 | Male Urogenital Diseases |