EndometriosisPhase 1NCT07755956
Phase Ia Trial of HHK001 Compared With Enantone in Patients With Endometriosis
A Phase 1 study testing HHK001 and Enantone in people with Endometriosis, run by Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd. at 2 sites in China.
Trial summary
The goal of this clinical trial is to find out how the study drug HHK001 compares to Enantone (an approved treatment for endometriosis) when given as a single 3.75 mg injection to participants with endometriosis. Both products contain the same active ingredient: leuprorelin acetate. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- HHK001 and Enantone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesChina
- Study dates
- 31 Oct 2026to 31 Mar 2027
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Voluntarily provide written informed consent;
- Female, aged 18-45 years, weight ≥ 40 kg, body mass index 19-28 kg/m²;
- The most recent menstrual cycle 21-35 days;
- Confirmed diagnosis of endometriosis, and suitable for GnRH agonist;
- Cervical cytology test result showing No Intraepithelial Lesion or Malignancy;
- No plan for pregnancy, egg cryopreservation or donation, and agree to use effective contraception from screening through 3 months after dosing.
Who cannot join
- Allergic to GnRH agonists/antagonists, or history of allergies to ≥3 different substances, or active allergic disease;
- With contraindications to rescue medication (ibuprofen);
- Current or past medical history of osteoporosis/osteopenia, pituitary tumor, epilepsy, depressive disorder, thromboembolic events, malignant tumors, unexplained abnormal uterine bleeding;
- Received any GnRH agonist/antagonist within 12 weeks before screening;
- Received medications that may significantly alter hypothalamic-pituitary-gonadal axis hormone levels within 4 weeks before screening;
- History of miscarriage within 4 weeks before screening;
- History of alcohol dependence, drug abuse or illicit substance use;
- Other conditions unsuitable for the trial judged by the investigator.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
Jiezhi Ma, +8615111401559, 23397861@qq.com
Dabao Xu
- Recruiting
Suzhou Municipal Hospital (The Affiliated Suzhou Hospital of Nanjing Medical University)
Suzhou, Jiangsu, 215002
Yonghong Qian, +8613606202875, qianyonghong99@sohu.com
Shunyu Hou
About this study
Official title: A Phase Ia Clinical Trial to Compare Pharmacokinetics, Pharmacodynamics, Safety and Preliminary Efficacy of HHK001 Versus Enantone in Patients With Endometriosis
The goal of this clinical trial is to find out how the study drug HHK001 compares to Enantone (an approved treatment for endometriosis) when given as a single 3.75 mg injection to participants with endometriosis. Both products contain the same active ingredient: leuprorelin acetate. We will check how the body absorbs and responds to each medicine, monitor possible side effects and treatment benefits.
Researchers will compare HHK001 to Enantone to test the advantages of its updated formulation.
- Conditions
- Endometriosis
- Being tested
- HHK001, Enantone
- Keywords
- leuprorelin, pharmacokinetics, pharmacodynamics, endometriosis
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HHK001Drug
Participants will receive a single subcutaneous injection of 3.75 mg HHK001 (investigational leuprorelin acetate preparation).
EnantoneDrug
Participants will receive a single subcutaneous injection of 3.75 mg Enantone (commercially-available leuprorelin acetate preparation).
| Study group | Role | What they receive |
|---|---|---|
| HHK001 | Experimental | Not described Receives: Drug: HHK001 |
| Enantone | Active comparator | Not described Receives: Drug: Enantone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentrations of leuprorelin acetate
Concentrations assessed by pre-specified methods
Measured: Baseline through 70 days post-dose
Concentrations of estradiol
Concentrations assessed by pre-specified methods
Measured: Baseline through 70 days post-dose
Secondary outcomes (2)
Number of participants with Adverse events
Adverse events
Measured: Baseline through 70 days post-dose
Changes from baseline in overall pain score
Pain scores measured on a 0-100 visual analog scale, with higher scores indicating greater pain severity
Measured: Baseline through 70 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start31 Oct 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies 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
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Feng, Study director, Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755956
- Sponsor's protocol ID
- HHK001-1a
- Status last verified
- Oct 2026
- First submitted
- 3 Aug 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD externally. The sponsor has not established an IPD sharing framework for early-phase pharmacokinetic trials.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia Clinical Trial to Compare Pharmacokinetics, Pharmacodynamics, Safety and Preliminary Efficacy of HHK001 Versus Enantone in Patients With Endometriosis
- ClinicalTrials.gov ID
- NCT07755956
- Acronym / sponsor ID
- HHK001-1a
- Conditions
- Endometriosis
- Keywords
- leuprorelin, pharmacokinetics, pharmacodynamics, endometriosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 10 Aug 2026 (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 clinical trial is to find out how the study drug HHK001 compares to Enantone (an approved treatment for endometriosis) when given as a single 3.75 mg injection to participants with endometriosis. Both products contain the same active ingredient: leuprorelin acetate. We will check how the body absorbs and responds to each medicine, monitor possible side effects and treatment benefits.
Researchers will compare HHK001 to Enantone to test the advantages of its updated formulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HHK001 | Experimental | Drug: HHK001 |
| Enantone | Active comparator | Drug: Enantone |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Voluntarily provide written informed consent;
- Female, aged 18-45 years, weight ≥ 40 kg, body mass index 19-28 kg/m²;
- The most recent menstrual cycle 21-35 days;
- Confirmed diagnosis of endometriosis, and suitable for GnRH agonist;
- Cervical cytology test result showing No Intraepithelial Lesion or Malignancy;
Key exclusion criteria (8 listed)
- Allergic to GnRH agonists/antagonists, or history of allergies to ≥3 different substances, or active allergic disease;
- With contraindications to rescue medication (ibuprofen);
- Current or past medical history of osteoporosis/osteopenia, pituitary tumor, epilepsy, depressive disorder, thromboembolic events, malignant tumors, unexplained abnormal uterine bleeding;
- Received any GnRH agonist/antagonist within 12 weeks before screening;
- Received medications that may significantly alter hypothalamic-pituitary-gonadal axis hormone levels within 4 weeks before screening;
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 |
|---|---|---|
| HHK001Participants will receive a single subcutaneous injection of 3.75 mg HHK001 (investigational leuprorelin acetate preparation). | Drug | HHK001 |
| EnantoneParticipants will receive a single subcutaneous injection of 3.75 mg Enantone (commercially-available leuprorelin acetate preparation). | Drug | Enantone |
Primary outcome
Concentrations of leuprorelin acetate
Time frame: Baseline through 70 days post-dose
Concentrations assessed by pre-specified methods
Concentrations of estradiol
Time frame: Baseline through 70 days post-dose
Concentrations assessed by pre-specified methods
2 secondary outcomes
Number of participants with Adverse events
Time frame: Baseline through 70 days post-dose
Changes from baseline in overall pain score
Time frame: Baseline through 70 days post-dose
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 2 Nov 2026.
- Individual participant dataSharing planned: No. No plan to share IPD externally. The sponsor has not established an IPD sharing framework for early-phase pharmacokinetic trials.
Related trials for Endometriosis
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PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
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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.
Feng study director
Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HHK001 and Enantone in people with Endometriosis, run by Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd. at 2 sites 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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Liang Li (+86 15800440760, liliang@hhkmed.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentrations of leuprorelin acetate (time frame: Baseline through 70 days post-dose). 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 2 Nov 2026.