InfertilityPhase 1NCT04878705
Safety and Tolerability of TWP-201 in Healthy Female Subjects
A Phase 1 study testing TWP-201 in people with Infertility, run by Shandong TheraWisdom Biopharma Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- TWP-201
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 17 May 2021to 31 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Second University Hospital, Sichuan University
Chengdu, Sichuan, 610041
Qin Yu, 8028-85501952, 908929936@qq.com
Lingli Zhang, 8028-85501952, zhanglingli@scu.edu.com
About this study
Official title: 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
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.
- Conditions
- Infertility
- Being tested
- TWP-201, placebo
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TWP-201Drug
a single subcutaneous injection
placeboDrug
a single subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| TWP-201 | Experimental | Not described Receives: Drug: TWP-201 |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)).
Measured: An average of 1 year
Secondary outcomes (6)
Maximum measured plasma concentration (Cmax) of TWP-201;
Measured: 28 days
Time to maximum plasma concentration (Tmax) of TWP-201;
Measured: 28 days
Half-life (T1/2) of TWP-201.
Measured: 28 days
Pharmacodynamics(PD).
Determination of serum concentrations of FSH, E2 and LH after dosing.
Measured: 28 days
Pharmacodynamics(PD).
The number of follicles after dosing. The size of follicles after dosing.
Measured: 28 days
Immunogenicity profile of TWP-201.
Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies and neutralizing antibodies.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start17 May 2021
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong TheraWisdom Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shengbin Ren, Principal investigator, Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04878705
- Sponsor's protocol ID
- TWP-201-11
- Status last verified
- Jul 2021
- First submitted
- 29 Apr 2021
- Last updated
- 19 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04878705
- Acronym / sponsor ID
- TWP-201-11
- Conditions
- Infertility
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Shandong TheraWisdom Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 May 2021 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 7 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TWP-201 | Experimental | Drug: TWP-201 |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TWP-201a single subcutaneous injection | Drug | TWP-201 |
| placeboa single subcutaneous injection | Drug | placebo |
Primary outcome
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)).
Time frame: An average of 1 year
6 secondary outcomes
Maximum measured plasma concentration (Cmax) of TWP-201;
Time frame: 28 days
Time to maximum plasma concentration (Tmax) of TWP-201;
Time frame: 28 days
Half-life (T1/2) of TWP-201.
Time frame: 28 days
Pharmacodynamics(PD).
Time frame: 28 days
Pharmacodynamics(PD).
Time frame: 28 days
Immunogenicity profile of TWP-201.
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shengbin Ren principal investigator
Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TWP-201 in people with Infertility, run by Shandong TheraWisdom Biopharma Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shengbin Ren (8021-60167707, shengbin.ren@therawisdom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). (time frame: An average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2021.