Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Huashan Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
This is a Phase Ia single-center, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, Pharmacokinetic of GenSci142 in Chinese healthy women.
This is a Phase 1a trial including single ascending dose levels and will assess the safety and tolerability of GenSci142 and describe the incidence of adverse events (AEs) for participants randomized at a ratio of 4:1 to GenSci142 or placebo within each cohort. Participants will receive one single dose of study treatment.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GenSci142 | Experimental | Single ascending dose levels,All subjects administered Single dose,Dose 1, Dose 2, Dose 3 |
|
| Placebo | Placebo Comparator | All subjects administered Single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GenSci142 | Drug | Vaginal insert |
| |
| Placebo GenSci142 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with adverse events (AEs) with onset after dose and until 15 days post-dose | In participants who have received at least one dose of GenSci142 or placebo. For each dose level cohort of GenSci142 and for the placebo group. | from first dose of study treatment up to 15 days post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Serum concentration of GenSci142 (ng/mL) | Concentrations of GenSci142 in serum samples at different time points are measured. Serum concentrations at different time points will be listed and summarized by descriptive statistics. | Day1-Day3 |
| Maximum serum concentration (Cmax, ng/mL) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei WANG | Contact | +86 18201085833 | wangwei13@genscigroup.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing ZHANG, Doctor | Huashan Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital Fudan University | Shanghai | Shanghai Municipality | 200040 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Vaginal insert |
|
PK parameters will be analyzed by non-compartmental analysis with WinNonlin® version 8.3 or above. |
| Day1-Day3 |
| Time to maximum serum concentration (Tmax, h) | PK parameters will be analyzed by non-compartmental analysis with WinNonlin® version 8.3 or above. | Day1-Day3 |
| Area under the concentration-time curve from the time zero to last measurable concentration (AUC0-t, h*ng/mL) | PK parameters will be analyzed by non-compartmental analysis with WinNonlin® version 8.3 or above. | Day1-Day3 |
| Area under concentration-time from time zero to infinity (AUC0-inf, h*ng/mL) | PK parameters will be analyzed by non-compartmental analysis with WinNonlin® version 8.3 or above. | Day1-Day3 |
| Terminal half-life (t1/2, h) | PK parameters will be analyzed by non-compartmental analysis with WinNonlin® version 8.3 or above. | Day1-Day3 |
| Apparent clearance (CL/F, mL/h) | PK parameters will be analyzed by non-compartmental analysis with WinNonlin® version 8.3 or above. | Day1-Day3 |
| Apparent volume of distribution (Vd/F, mL) | PK parameters will be analyzed by non-compartmental analysis with WinNonlin® version 8.3 or above. | Day1-Day3 |
| Anti-drug antibody (ADA) prevalence (%) or change of binding titers against GenSci142 in blood before administration and at the follow-up visit | For each dose level. | Day1-Day15 |
| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| D001424 | Bacterial Infections |
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided