drugset / Trial / NCT03535103
Study on the Safety and Pharmacokinetics of LM001 and Gonal-F® in Healthy Women
RandomizedCrossoverOpen-labelBasic science
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.
Timeline
- Start
- 2018-06-01
- Primary completion
- 2019-12-31
- Completion
- 2019-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gonal-f | Protein / enzyme biologic | 225 iu | Subcutaneous |
| Subject | LM001 | Protein / enzyme biologic | 225 iu | Subcutaneous |