Infertility, FemalePhase 1NCT06864793
Study on the Pharmacokinetics and Safety of QL1012D and Gonal-F® in Healthy Female Volunteers
A Phase 1 study testing QL1012D and Gonal-F® in people with Infertility, Female, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- What is being tested?
- QL1012D and Gonal-F®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 6 Apr 2025to Apr 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Infertility, Female
- Being tested
- QL1012D, Gonal-F®
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL1012DDrug
Also called Follitropin alfa
A single Subcutaneous injection, 225IU
Gonal-F®Drug
Also called Follitropin alfa
A single Subcutaneous injection, 225IU
| Study group | Role | What they receive |
|---|---|---|
| Arm A QL1012D | Experimental | Not described Receives: Drug: QL1012D |
| Arm B Gonal-F® | Active comparator | Not described Receives: Drug: Gonal-F® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax (maximum plasma concentration)
Maxmum observed serum concentration (Cmax) of QL1012D＆Gonal-f® in healthy Chinese female subjects.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start6 Apr 2025
- Primary completion4 Feb 2026
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864793
- Sponsor's protocol ID
- QL1012D-101
- Status last verified
- Feb 2026
- First submitted
- 4 Mar 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06864793
- Acronym / sponsor ID
- QL1012D-101
- Conditions
- Infertility, Female
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Apr 2025 (actual)
- Primary completion
- 4 Feb 2026 (actual)
- Study completion
- Apr 2026 (estimated)
- First posted
- 7 Mar 2025 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A QL1012D | Experimental | Drug: QL1012D |
| Arm B Gonal-F® | Active comparator | Drug: Gonal-F® |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| QL1012DAlso: Follitropin alfaA single Subcutaneous injection, 225IU | Drug | Arm A QL1012D |
| Gonal-F®Also: Follitropin alfaA single Subcutaneous injection, 225IU | Drug | Arm B Gonal-F® |
Primary outcome
Cmax (maximum plasma concentration)
Time frame: 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
Maxmum observed serum concentration (Cmax) of QL1012D＆Gonal-f® in healthy Chinese female subjects.
AUC (area under the curve)
Time frame: 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
Adjusted geometric means of area under the serum concentration-time curve (AUC) of QL1012D＆Gonal-f® in healthy Chinese female subjects.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 QL1012D and Gonal-F® in people with Infertility, Female, run by Qilu Pharmaceutical 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 8 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (maximum plasma concentration) (time frame: 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). The study lists 2 primary outcomes in all. 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 17 Feb 2026.