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Status unknownNCT03535103Updated May 29, 2018

Study on the Safety and Pharmacokinetics of LM001 and Gonal-F® in Healthy Women

A Phase 1 interventional study of Gonal-F® and LM001 in Infertility, Female, sponsored by Alphamab Jilin Co., Ltd.. Status unknown. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-29.

Sponsored by Alphamab Jilin Co., Ltd. · Phase 1, Interventional, and Basic science

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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 injection (LM001), compared with Gonal-F®, both given subcutaneously.

02

Conditions studied

  • Infertility, Female
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's planned enrollment of 32 is below the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Alphamab Jilin Co., Ltd. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Able and willing to provide written informed consent.
  2. Agreed to take effective contraceptive measures during and 6 months after the end of the study period.
  3. Age between 18 to 40 years (inclusive).
  4. Body weight ≥45 kg, body mass index (BMI) of ≥18 and ≤28 kg/m2,
  5. Regular menstruation cycle (25 to 34 days, inclusive).
  6. 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.

Exclusion criteria

Exclusion Criteria:

  1. Smoke ≥5 cigarettes or the equivalent per day within 3 months prior to the study
  2. History of hypersensitivity to FSH, or hypersensitivity to luteinizing hormone releasing hormone agonist or something like that.
  3. 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.
  4. Taken any liver enzyme activity relative drug within 28 days prior to the screening.
  5. Take any prescription drug, OTC drug, vitamin product or herbal medicine within 14 days prior to the screening.
  6. 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.
  7. Major changes in diet or exercise habits recently
  8. Participation in a clinical study within 3 months prior to the study.
  9. Acute disease or combination therapy from the screening to the beginning time of the study.
  10. Take any alcoholic product within 48 hours prior to the study.
  11. Take chocolate, any caffeine-containing or xanthine-rich food or drinks within 48 hours prior to using the drug;
  12. Blood donation or massive blood losing (>450mL) within 3 months prior to the screening;
  13. Viral hepatitis (including hepatitis B and hepatitis C), HIV, and Treponema pallidum positive.
  14. 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;
  15. Baseline of serum FSH ≥15 IU/L.
  16. History of ovarian hyperstimulation syndrome (OHSS).
  17. Other abnormalities judged by researchers of the study
  18. Abnormal physical examination and clinical significance judged by researchers of the study
  19. Abnormal vital signs and clinical significance judged by researchers of the study.
  20. Abnormal laboratory tests with clinically relevance.
  21. Abnormal electrocardiogram [ECG] findings.
  22. III/IV class endometriosis, submucous myoma of uterus, endocrine abnormalities within 6 months prior to the study.
  23. Abnormal imaging examination and clinical significance judged by researchers of the study, such as with a uterine fibroid diameter ≥ 40 mm.
  24. Pregnancy or lactation period.
  25. Alcohol screening positive.
  26. Urine drug screening positive
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    ARM A

    Gonal-F®

    Drug: Gonal-F®

  • Experimental
    ARM B

    LM001

    Drug: LM001

Interventions

  • DrugGonal-F®

    A single Subcutaneous injection, 225IU

    Also known as: Follitropin alfa

  • DrugLM001

    A single Subcutaneous injection, 225IU

    Also known as: Follitropin alfa

06

What researchers measure

Primary outcomes

  1. 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.

    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.

  2. 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.

    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.

Other outcomes

  1. Time of Maxmum observed serum concentration (Tmax) of LM001＆Gonal-f® in healthy Chinese female subjects.

    Time of Maxmum observed serum concentration (Tmax) 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.

  2. Serum clearance(CL) of of LM001＆Gonal-f® in healthy Chinese female subjects.

    Serum clearance(CL) of 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.

  3. Adjusted geometric means of area under the serum concentration-time curve from time zero extrapolated to infinite time(AUC(INF))for LM001＆Gonal-f® in healthy Chinese female subjects.

    Adjusted geometric means of area under the serum concentration-time curve from time zero extrapolated to infinite time(AUC(INF))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.

  4. Serum Half-life(T-HALF)of LM001＆Gonal-f® in healthy Chinese female subjects.

    Serum Half-life(T-HALF)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.

  5. Apparent volume of distribution（VD）)of LM001＆Gonal-f® in healthy Chinese female subjects.

    Apparent volume of distribution（VD）)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.

  6. Expression of terminal clearance rate constant（λ z ）of LM001＆Gonal-f® in healthy Chinese female subjects.

    Expression of terminal clearance rate constant（λ z ）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.

  7. Number of Participants with Abnormal Labortory Values and/or Adverse Events that are realated to treatment(SAEs) and AEs of special interest.

    Number of Participants with Abnormal Labortory Values and/or Adverse Events that are realated to treatment(SAEs) and AEs of special interest.

    Time frame: From screening to up to 16 days.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03535103
Lead sponsor
Alphamab Jilin Co., Ltd.
Responsible party
Sponsor
First posted
May 24, 2018
Start date
Jun 1, 2018 (estimated)
Primary completion
Dec 31, 2019 (estimated)
Completion
Dec 31, 2019 (estimated)
Last update
May 29, 2018

Study contacts

Yanhua Ding, M.D.
Contact
dingyanhua2003@126.com
86-0431-88782168
lei gao, M.D.
Contact
398027192@qq.com

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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