Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:04 AM
Study NCT ID:
NCT04878705
Status:
UNKNOWN
Last Update Posted:
2021-07-19
First Post:
2021-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of TWP-201 in Healthy Female Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-15', 'studyFirstSubmitDate': '2021-04-29', 'studyFirstSubmitQcDate': '2021-05-05', 'lastUpdatePostDateStruct': {'date': '2021-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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)).', 'timeFrame': 'An average of 1 year'}], 'secondaryOutcomes': [{'measure': 'Maximum measured plasma concentration (Cmax) of TWP-201;', 'timeFrame': '28 days'}, {'measure': 'Time to maximum plasma concentration (Tmax) of TWP-201;', 'timeFrame': '28 days'}, {'measure': 'Half-life (T1/2) of TWP-201.', 'timeFrame': '28 days'}, {'measure': 'Pharmacodynamics(PD).', 'timeFrame': '28 days', 'description': 'Determination of serum concentrations of FSH, E2 and LH after dosing.'}, {'measure': 'Pharmacodynamics(PD).', 'timeFrame': '28 days', 'description': 'The number of follicles after dosing. The size of follicles after dosing.'}, {'measure': 'Immunogenicity profile of TWP-201.', 'timeFrame': '28 days', 'description': 'Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies and neutralizing antibodies.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body weight ≥ 45 kg, 19 ≤ body mass index (BMI) ≤ 28 kg /m2;\n* Women with sexual experience, potential fertility and regular menstrual cycle (25-34 days) (including boundary value);\n* The levels of sex hormones were normal or abnormal without clinical significance at the time of screening;\n* The physiological structure of uterus and bilateral ovaries was normal or abnormal by ultrasound examination, without clinical significance;\n\nExclusion Criteria:\n\n* Known the history of stage III / IV endometriosis, submucosal myoma and endocrine abnormality within 6 months before enrollment;\n* Known the history of ovarian hyperstimulation syndrome (OHSS);\n* Premature ovarian failure, decreased ovarian reserve function (Antral Follicle Counting \\< 3), high ovarian response, polycystic ovary syndrome, unexplained vaginal bleeding or endometrial hyperplasia;\n* Any FSH or HMG preparations were used within 3 months before the first study;\n* Pregnancy or lactating women.'}, 'identificationModule': {'nctId': 'NCT04878705', 'briefTitle': 'Safety and Tolerability of TWP-201 in Healthy Female Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shandong TheraWisdom Biopharma Co., Ltd.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'TWP-201-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TWP-201', 'interventionNames': ['Drug: TWP-201']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'TWP-201', 'type': 'DRUG', 'description': 'a single subcutaneous injection', 'armGroupLabels': ['TWP-201']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'a single subcutaneous injection', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qin Yu', 'role': 'CONTACT', 'email': '908929936@qq.com', 'phone': '8028-85501952'}, {'name': 'Lingli Zhang', 'role': 'CONTACT', 'email': 'zhanglingli@scu.edu.com', 'phone': '8028-85501952'}], 'facility': 'West China Second University Hospital, Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Shengbin Ren', 'role': 'CONTACT', 'email': 'shengbin.ren@therawisdom.com', 'phone': '8021-60167707'}], 'overallOfficials': [{'name': 'Shengbin Ren', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong TheraWisdom Biopharma Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}