Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT06864793
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-11
First Post:
2025-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study on the Pharmacokinetics and Safety of QL1012D and Gonal-F® in Healthy Female Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571801', 'term': 'follitropin alfa'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-06', 'studyFirstSubmitDate': '2025-03-04', 'studyFirstSubmitQcDate': '2025-03-04', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax (maximum plasma concentration)', 'timeFrame': 'First Period: From pre-dose (0 hour) to 216 hours post-dose on Day 1. Second Period: From pre-dose (0 hour) to 216 hours post-dose on Day 11', 'description': 'Maxmum observed serum concentration (Cmax) of QL1012D＆Gonal-f® in healthy Chinese female subjects.'}, {'measure': 'AUC (area under the curve)', 'timeFrame': 'First Period: From pre-dose (0 hour) to 216 hours post-dose on Day 1. Second Period: From pre-dose (0 hour) to 216 hours post-dose on Day 11', 'description': 'Adjusted geometric means of area under the serum concentration-time curve (AUC) of QL1012D＆Gonal-f® in healthy Chinese female subjects.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility, Female']}, 'descriptionModule': {'briefSummary': 'The goal of this Interventional study is to Compare the Pharmacokinetics and Safety of Recombinant Human Follicle Stimulating Hormone Injection (QL1012D) and Gonal-F® in Healthy Female Volunteers. It aims to evaluate the bioequivalence of recombinant human follicle stimulating hormone injection (QL1012D) and Gonal-F®, both given subcutaneously.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female, Age between 18 to 45 years (inclusive).\n* Body mass index (BMI) of ≥18 and ≤28 kg/m2, body weight ≥45 kg.\n* With a history of sexual activity\n* Regular menstruation cycle (25 to 35 days, inclusive).\n* Normal sex hormone levels, or abnormalities deemed clinically insignificant by the investigator.\n* Reached the standard within the time window after receiving the down-regulated drug.\n* Agreed to take effective contraceptive measures during and 6 months after the end of the study period.\n* Willing to participate in this clinical trial, understanding the study procedures, and able to provide written informed consent.\n\nExclusion Criteria:\n\n* History of ovarian hyperstimulation syndrome, or polycystic ovary syndrome, or ovarian enlargement or cysts not caused by polycystic ovary syndrome, or primary ovarian failure; history of hypothalamic or pituitary tumors; history of malignancy; History of thrombosis; or other diseases that considered to influence the study by the investigator.\n* Unexplained reproductive tract bleeding.\n* Thin-layer cytology examination deemed clinically significant by the investigator.\n* Vital signs, physical examination, 12-lead electrocardiogram, or laboratory examination deemed clinically significant by the investigator with.\n* Pregnancy or lactation period, or positive human chorionic gonadotropin (HCG) examination.\n* Known to be allergic to follicle-stimulating hormone (FSH), or gonadotropin-releasing hormone agonists (GnRH-a) or their analogs\n* Consume strong coffee or tea daily\n* Historic abuse of alcoholic beverages\n* Smoke ≥5 cigarettes per day within 3 months prior to the study\n* History of drug abuse\n* Unsuitable for participation by the investigator.'}, 'identificationModule': {'nctId': 'NCT06864793', 'briefTitle': 'Study on the Pharmacokinetics and Safety of QL1012D and Gonal-F® in Healthy Female Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Qilu Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Randomized, Double-blind, Two-Period, Crossover Study to Compare the Pharmacokinetics and Safety of Recombinant Human Follicle Stimulating Hormone Injection (QL1012D) and Gonal-F® in Healthy Female Volunteers', 'orgStudyIdInfo': {'id': 'QL1012D-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A QL1012D', 'interventionNames': ['Drug: QL1012D']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B Gonal-F®', 'interventionNames': ['Drug: Gonal-F®']}], 'interventions': [{'name': 'QL1012D', 'type': 'DRUG', 'otherNames': ['Follitropin alfa'], 'description': 'A single Subcutaneous injection, 225IU', 'armGroupLabels': ['Arm A QL1012D']}, {'name': 'Gonal-F®', 'type': 'DRUG', 'otherNames': ['Follitropin alfa'], 'description': 'A single Subcutaneous injection, 225IU', 'armGroupLabels': ['Arm B Gonal-F®']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Lupeng Jin, Project Manager', 'role': 'CONTACT', 'email': 'lupeng.jin@qilu-pharma.com', 'phone': '0531-55821177'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}