Bacterial Vaginosis
Conditions
Keywords
Bacterial Infections, Vaginitis, Vaginal Diseases, Genital Diseases, Female, Female Urogenital Diseases, Gardnerella spp., Gardnerella vaginalis, GenSci142
Brief summary
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.
Detailed description
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.
Interventions
DRUGGenSci142
Vaginal insert
DRUGPlacebo GenSci142
Vaginal insert
Sponsors
Huashan Hospital
Changchun GeneScience Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy women of childbearing potential aged 18-55 years (inclusive) at the time of signing the Informed Consent Form (ICF); * Sexually active and willing to undergo vaginal administration of the study product；participants must agree to avoid the use of other intravaginal products (e.g., contraception ointments, gels, foams, sponges, lubricants, irrigation solutions, tampons, etc.) throughout the trial; * During the screening period, there are no clinically significant abnormalities in medical history, vital signs, physical examination, gynecological examination, laboratory test (hematology, routine urinalysis, clinical chemistry, coagulation function, vaginal microbiome test) and 12-lead ECG, or any out-of-range laboratory values or other findings must be assessed by the investigator as not clinically significant;
Exclusion criteria
* Those experiencing stinging or burning sensation, hemorrhage, pruritus, erythema, edema, or increased discharge due to previous or current use of vaginal preparations, or those with any factors that possibly have an impact on evaluation of administration site irritation, or those with other factors that may have an impact on vaginal administration, such as genital malformation; * Serious infections, chronic infections, opportunistic infections, etc. within 3 months prior to screening, and infections treated with systemic antimicrobial drugs (including but not limited to viruses, bacteria, fungi, and parasitic infections) within 4 weeks prior to randomization; * Surgical history: a. vaginal, pelvic or cervical surgery within 90 days prior to screening or planning to undergo surgery during the study; b. hysterectomy; c. other major surgery within 30 days prior to screening or planning to undergo other surgeries during the study;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with adverse events (AEs) with onset after dose and until 15 days post-dose | from first dose of study treatment up to 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum serum concentration (Cmax, ng/mL) | Day1-Day3 | PK parameters will be analyzed by non-compartmental analysis with WinNonlin® version 8.3 or above. |
| Time to maximum serum concentration (Tmax, h) | Day1-Day3 | PK parameters will be analyzed by non-compartmental analysis with WinNonlin® version 8.3 or above. |
| Area under the concentration-time curve from the time zero to last measurable concentration (AUC0-t, h*ng/mL) | Day1-Day3 | PK parameters will be analyzed by non-compartmental analysis with WinNonlin® version 8.3 or above. |
| Area under concentration-time from time zero to infinity (AUC0-inf, h*ng/mL) | Day1-Day3 | PK parameters will be analyzed by non-compartmental analysis with WinNonlin® version 8.3 or above. |
| Serum concentration of GenSci142 (ng/mL) | Day1-Day3 | 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. |
| Apparent clearance (CL/F, mL/h) | Day1-Day3 | PK parameters will be analyzed by non-compartmental analysis with WinNonlin® version 8.3 or above. |
| Apparent volume of distribution (Vd/F, mL) | Day1-Day3 | PK parameters will be analyzed by non-compartmental analysis with WinNonlin® version 8.3 or above. |
| Anti-drug antibody (ADA) prevalence (%) or change of binding titers against GenSci142 in blood before administration and at the follow-up visit | Day1-Day15 | For each dose level. |
| Terminal half-life (t1/2, h) | Day1-Day3 | PK parameters will be analyzed by non-compartmental analysis with WinNonlin® version 8.3 or above. |
Countries
China
Contacts
Primary ContactWei WANG
Outcome results
None listed