Study on the Pharmacokinetics and Safety of QL1012D and G... | NCT06864793

Studies
Study on the Pharmacokinetics and Safety of QL1012D and Gonal-F® in Healthy Female Volunteers

NCT06864793

Sponsor

Qilu Pharmaceutical Co., Ltd.

Status

Active, not recruiting

Last Update Posted

Feb 17, 2026Actual

Enrollment

48Estimated

Phase

Phase 1

Conditions

Infertility, Female

Interventions

QL1012D
Gonal-F®

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 6, 2025Actual

Primary Completion Date

Feb 4, 2026Actual

Completion Date

Apr 2026Estimated

First Submitted Date

Mar 4, 2025

First Submission Date that Met QC Criteria

Mar 4, 2025

First Posted Date

Mar 7, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2026

Last Update Posted Date

Feb 17, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Estimated

Label	Type	Description	Intervention Names
Arm A QL1012D	Experimental		Drug: QL1012D
Arm B Gonal-F®	Active Comparator		Drug: Gonal-F®

Name	Type	Description	Arm Group Labels	Other Names
QL1012D	Drug	A single Subcutaneous injection, 225IU	Arm A QL1012D	Follitropin alfa

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cmax (maximum plasma concentration)	Maxmum observed serum concentration (Cmax) of QL1012D＆Gonal-f® in healthy Chinese female subjects.	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
AUC (area under the curve)	Adjusted geometric means of area under the serum concentration-time curve (AUC) of QL1012D＆Gonal-f® in healthy Chinese female subjects.	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female, Age between 18 to 45 years (inclusive).
Body mass index (BMI) of ≥18 and ≤28 kg/m2, body weight ≥45 kg.
With a history of sexual activity
Regular menstruation cycle (25 to 35 days, inclusive).
Normal sex hormone levels, or abnormalities deemed clinically insignificant by the investigator.
Reached the standard within the time window after receiving the down-regulated drug.
Agreed to take effective contraceptive measures during and 6 months after the end of the study period.
Willing to participate in this clinical trial, understanding the study procedures, and able to provide written informed consent.

Exclusion Criteria:

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.
Unexplained reproductive tract bleeding.
Thin-layer cytology examination deemed clinically significant by the investigator.
Vital signs, physical examination, 12-lead electrocardiogram, or laboratory examination deemed clinically significant by the investigator with.
Pregnancy or lactation period, or positive human chorionic gonadotropin (HCG) examination.
Known to be allergic to follicle-stimulating hormone (FSH), or gonadotropin-releasing hormone agonists (GnRH-a) or their analogs
Consume strong coffee or tea daily
Historic abuse of alcoholic beverages
Smoke ≥5 cigarettes per day within 3 months prior to the study
History of drug abuse
Unsuitable for participation by the investigator.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases