Safety and Tolerability of TWP-201 in Healthy Female Subjects
A Randomized, Double-blind, Placebo-controlled, Single Dose, Escalation, Phase I Clinical Trial to Evaluate the Safety and Tolerability of TWP-201 in Healthy Female Subjects
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2021
CompletedFirst Posted
Study publicly available on registry
May 7, 2021
CompletedStudy Start
First participant enrolled
May 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedJuly 19, 2021
July 1, 2021
1.5 years
April 29, 2021
July 15, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
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
Pharmacodynamics(PD).
28 days
- +1 more secondary outcomes
Study Arms (2)
TWP-201
EXPERIMENTALplacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
West China Second University Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shengbin Ren
Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2021
First Posted
May 7, 2021
Study Start
May 17, 2021
Primary Completion
October 31, 2022
Study Completion
December 31, 2022
Last Updated
July 19, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share