Bioequivalence Clinical Trial of Recombinant Human Follicle-stimulating Hormone JZB30

PHASE1CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

January 4, 2021

Primary Completion Date

November 16, 2021

Study Completion Date

January 17, 2022

Conditions
BioequivalenceHealthy VolunteersPharmacokineticsSafetyImmunogenicity
Interventions
DRUG

Gonal F

The reference formulation is the recombinant human follicle-stimulating hormone injection (Gonal-f®) originally developed and produced by Merck Serono

DRUG

jzb30

The test formulation is the recombinant human follicle-stimulating hormone injection (code: JZB30) produced by Shanghai Jingze Biotechnology Co., Ltd./Chengdu Jingze Biopharmaceutical Co., Ltd.

Trial Locations (1)

610041

West China Second University Hospital, Chengdu

All Listed Sponsors
collaborator

Shanghai Jingze Biotechnology Co., Ltd.

UNKNOWN

collaborator

Chengdu Jingze pharmaceutical Co., Ltd.

UNKNOWN

lead

West China Second University Hospital

OTHER

NCT06778304 - Bioequivalence Clinical Trial of Recombinant Human Follicle-stimulating Hormone JZB30 | Biotech Hunter | Biotech Hunter