Trials / Unknown
UnknownNCT03535103
Study on the Safety and Pharmacokinetics of LM001 and Gonal-F® in Healthy Women
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
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- Sponsor
- Alphamab Jilin Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gonal-F® | A single Subcutaneous injection, 225IU |
| DRUG | LM001 | A single Subcutaneous injection, 225IU |
Timeline
- Start date
- 2018-06-01
- Primary completion
- 2019-12-31
- Completion
- 2019-12-31
- First posted
- 2018-05-24
- Last updated
- 2018-05-29
Source: ClinicalTrials.gov record NCT03535103. Inclusion in this directory is not an endorsement.