Infertility
Conditions
Brief summary
This study is a randomized, double-blind, placebo-controlled, single dose, escalation, phase I clinical trial to evaluate the safety and tolerability of recombinant human follicle stimulating hormone Fc fusion protein injection (TWP-201) in healthy female subjects. The objective of the trial is to evaluate the safety and tolerability of TWP-201 in healthy female subjects.
Interventions
DRUGTWP-201
a single subcutaneous injection
DRUGplacebo
a single subcutaneous injection
Sponsors
Shandong TheraWisdom Biopharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
Yes
Inclusion criteria
* Body weight ≥ 45 kg, 19 ≤ body mass index (BMI) ≤ 28 kg /m2; * Women with sexual experience, potential fertility and regular menstrual cycle (25-34 days) (including boundary value); * The levels of sex hormones were normal or abnormal without clinical significance at the time of screening; * The physiological structure of uterus and bilateral ovaries was normal or abnormal by ultrasound examination, without clinical significance;
Exclusion criteria
* Known the history of stage III / IV endometriosis, submucosal myoma and endocrine abnormality within 6 months before enrollment; * Known the history of ovarian hyperstimulation syndrome (OHSS); * Premature ovarian failure, decreased ovarian reserve function (Antral Follicle Counting \< 3), high ovarian response, polycystic ovary syndrome, unexplained vaginal bleeding or endometrial hyperplasia; * Any FSH or HMG preparations were used within 3 months before the first study; * Pregnancy or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events, serious adverse and abnormal laboratory values event (defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)). | An average of 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum measured plasma concentration (Cmax) of TWP-201; | 28 days | — |
| Time to maximum plasma concentration (Tmax) of TWP-201; | 28 days | — |
| Half-life (T1/2) of TWP-201. | 28 days | — |
| Pharmacodynamics(PD). | 28 days | Determination of serum concentrations of FSH, E2 and LH after dosing. |
| Immunogenicity profile of TWP-201. | 28 days | Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies and neutralizing antibodies. |
Countries
China
Contacts
Primary ContactShengbin Ren
Outcome results
None listed