Infertility, FemalePhase 1NCT03535103
Study on the Safety and Pharmacokinetics of LM001 and Gonal-F® in Healthy Women
A Phase 1 study testing Gonal-F® and LM001 in people with Infertility, Female, run by Alphamab Jilin Co., Ltd..
Trial summary
Brief Summary: LM001 is a recombinant human Follicle Stimulating Hormone (r-hFSH) Injection, which is proposed for Assisted Reproductive Technology (ART). This is a randomized, open-label, two-period, two-crossover study to evaluate the safety and pharmacokinetics of recombinant human follicle stimulating hormone… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Gonal-F® and LM001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2018to 31 Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able and willing to provide written informed consent.
- Agreed to take effective contraceptive measures during and 6 months after the end of the study period.
- Age between 18 to 40 years (inclusive).
- Body weight ≥45 kg, body mass index (BMI) of ≥18 and ≤28 kg/m2,
- Regular menstruation cycle (25 to 34 days, inclusive).
- Normal findings in sex hormone examinations, including FSH, LH, prolactin (PRL), estradiol (E2), progesterone (P), testosterone (T) unless the investigator considers an abnormality to be clinically irrelevant for this study.
Who cannot join
- Smoke ≥5 cigarettes or the equivalent per day within 3 months prior to the study
- History of hypersensitivity to FSH, or hypersensitivity to luteinizing hormone releasing hormone agonist or something like that.
- Historic abuse of alcoholic beverages and drugs (Drink 14 units of alcohol/week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine.
- Taken any liver enzyme activity relative drug within 28 days prior to the screening.
- Take any prescription drug, OTC drug, vitamin product or herbal medicine within 14 days prior to the screening.
- Taken special diets (including pitaya, mango, grapefruit, etc.) or have strenuous exercise, or something affect the absorption, distribution, metabolism, excretion, etc. of the drug within 2 weeks prior to the study.
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- Major changes in diet or exercise habits recently
- Participation in a clinical study within 3 months prior to the study.
- Acute disease or combination therapy from the screening to the beginning time of the study.
- Take any alcoholic product within 48 hours prior to the study.
- Take chocolate, any caffeine-containing or xanthine-rich food or drinks within 48 hours prior to using the drug;
- Blood donation or massive blood losing (>450mL) within 3 months prior to the screening;
- Viral hepatitis (including hepatitis B and hepatitis C), HIV, and Treponema pallidum positive.
- History of significant diseases such as circulatory, endocrine, neurological, reproductive, digestive, and respiratory systems, hematology, immunology, psychiatry, and metabolic abnormalities, or past or current medical history that could interfere with the test results, eg subjects with or have suffered from hypothyroidism, adrenocortical insufficiency and hyperprolactinemia, polycystic ovary syndrome, and ovarian dysfunction, premature ovarian failure (POI) or primary ovarian failure, unexplained uterine bleeding, hypothalamic or pituitary tumors, ovarian, uterine or breast cancer, history of thrombosis, history of malignancy;
- Baseline of serum FSH ≥15 IU/L.
- History of ovarian hyperstimulation syndrome (OHSS).
- Other abnormalities judged by researchers of the study
- Abnormal physical examination and clinical significance judged by researchers of the study
- Abnormal vital signs and clinical significance judged by researchers of the study.
- Abnormal laboratory tests with clinically relevance.
- Abnormal electrocardiogram [ECG] findings.
- III/IV class endometriosis, submucous myoma of uterus, endocrine abnormalities within 6 months prior to the study.
- Abnormal imaging examination and clinical significance judged by researchers of the study, such as with a uterine fibroid diameter ≥ 40 mm.
- Pregnancy or lactation period.
- Alcohol screening positive.
- Urine drug screening positive
Trial locations and contacts
No sites are listed yet.
lei gao, M.D. contact
About this study
Official title: A Randomized, Open-label, Two-Period, Two-Crossover Study to Compare the Safety and Pharmacokinetics of Recombinant Human Follicle Stimulating Hormone Injection (LM001) and Gonal-F® in Healthy Female Volunteers
Brief Summary: LM001 is a recombinant human Follicle Stimulating Hormone (r-hFSH) Injection, which is proposed for Assisted Reproductive Technology (ART). This is a randomized, open-label, two-period, two-crossover study to evaluate the safety and pharmacokinetics of recombinant human follicle stimulating hormone injection (LM001), compared with Gonal-F®, both given subcutaneously.
- Conditions
- Infertility, Female
- Being tested
- Gonal-F®, LM001
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gonal-F®Drug
Also called Follitropin alfa
A single Subcutaneous injection, 225IU
LM001Drug
Also called Follitropin alfa
A single Subcutaneous injection, 225IU
| Study group | Role | What they receive |
|---|---|---|
| ARM A | Experimental | Gonal-F® Receives: Drug: Gonal-F® |
| ARM B | Experimental | LM001 Receives: Drug: LM001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maxmum observed serum concentration (Cmax) of LM001＆Gonal-f® in healthy Chinese female subjects.
Maxmum observed serum concentration (Cmax) of LM001＆Gonal-f® in healthy Chinese female subjects.
Measured: within 0.5h pre-dose, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose.
Adjusted geometric means of area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUC(0-T))for LM001＆Gonal-f® in healthy Chinese female subjects.
Adjusted geometric means of area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUC(0-T))for LM001＆Gonal-f® in healthy Chinese female subjects.
Measured: within 0.5h pre-dose, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start1 Jun 2018 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (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.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alphamab Jilin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03535103
- Sponsor's protocol ID
- KNJR-2018-001
- Status last verified
- May 2018
- First submitted
- 2 May 2018
- Last updated
- 29 May 2018
- 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 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Two-Period, Two-Crossover Study to Compare the Safety and Pharmacokinetics of Recombinant Human Follicle Stimulating Hormone Injection (LM001) and Gonal-F® in Healthy Female Volunteers
- ClinicalTrials.gov ID
- NCT03535103
- Acronym / sponsor ID
- KNJR-2018-001
- Conditions
- Infertility, Female
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Alphamab Jilin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2018 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 24 May 2018 (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.
Brief Summary: LM001 is a recombinant human Follicle Stimulating Hormone (r-hFSH) Injection, which is proposed for Assisted Reproductive Technology (ART). This is a randomized, open-label, two-period, two-crossover study to evaluate the safety and pharmacokinetics of recombinant human follicle stimulating hormone injection (LM001), compared with Gonal-F®, both given subcutaneously.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM A | Experimental | Drug: Gonal-F®Gonal-F® |
| ARM B | Experimental | Drug: LM001LM001 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Able and willing to provide written informed consent.
- Agreed to take effective contraceptive measures during and 6 months after the end of the study period.
- Age between 18 to 40 years (inclusive).
- Body weight ≥45 kg, body mass index (BMI) of ≥18 and ≤28 kg/m2,
- Regular menstruation cycle (25 to 34 days, inclusive).
Key exclusion criteria (26 listed)
- Smoke ≥5 cigarettes or the equivalent per day within 3 months prior to the study
- History of hypersensitivity to FSH, or hypersensitivity to luteinizing hormone releasing hormone agonist or something like that.
- Historic abuse of alcoholic beverages and drugs (Drink 14 units of alcohol/week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine.
- Taken any liver enzyme activity relative drug within 28 days prior to the screening.
- Take any prescription drug, OTC drug, vitamin product or herbal medicine within 14 days prior to the 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 |
|---|---|---|
| Gonal-F®Also: Follitropin alfaA single Subcutaneous injection, 225IU | Drug | ARM A |
| LM001Also: Follitropin alfaA single Subcutaneous injection, 225IU | Drug | ARM B |
Primary outcome
Maxmum observed serum concentration (Cmax) of LM001＆Gonal-f® in healthy Chinese female subjects.
Time frame: within 0.5h pre-dose, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose.
Maxmum observed serum concentration (Cmax) of LM001＆Gonal-f® in healthy Chinese female subjects.
Adjusted geometric means of area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUC(0-T))for LM001＆Gonal-f® in healthy Chinese female subjects.
Time frame: within 0.5h pre-dose, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose.
Adjusted geometric means of area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUC(0-T))for LM001＆Gonal-f® in healthy Chinese female subjects.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2018.
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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.
lei gao, M.D. contact
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gonal-F® and LM001 in people with Infertility, Female, run by Alphamab Jilin Co., Ltd..
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 26 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: status not confirmed, as of the sponsor's last update on 29 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanhua Ding, M.D. (86-0431-88782168, dingyanhua2003@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maxmum observed serum concentration (Cmax) of LM001＆Gonal-f® in healthy Chinese female subjects. (time frame: within 0.5h pre-dose, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours 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 29 May 2018.