NCT06095206

The Pharmacokinetic and Bioavailability of GenSci094 Before and After a Change in Manufacturing Site

to Evaluate the Pharmacokinetic Characteristics and Bioavailability of Recombinant Human Follicle Stimulating Hormone-CTP Fusion Protein Injection（GenSci094） in Healthy Male Subjects Before and After a Change in Manufacturing Site

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The bioavailability study is intended to evaluate the pharmacokinetic (PK) characteristics and the bioavailability of the two formulations in humans before and after the change of production site, in order to assess the possible impact of the site change on the pharmacokinetic characteristics of the drug and to clarify whether the two formulations are comparable before and after the change.

Detailed description

This study used a single-center, open, randomized, single-dose, parallel-controlled trial design, and the study drug consisted of 1) the test drug (GenSci094 after the change in manufacturing site) and 2) the control drug (GenSci094 before the change in manufacturing site). Screened 48 healthy male subjects were randomly assigned to Group A (test drug) or Group B (control drug), randomized at timeprevious day（ D-1）, admitted to the Phase I clinical trial ward and put on a uniform diet; received 150 μg subcutaneous injection administration of the study drug on the following day (D1), and blood was collected for PK and immunogenicity up today 18（ D18）; and completed a safety telephone follow-up on day 25（D25）.

Conditions

• Infertility

Interventions

Type	Name	Description
DRUG	GenSci094	On the morning of day 1 pre-meal, a single SC injection of 150 μg GenSci094 was administered in the abdominal wall.

Timeline

• Start date: 2023-09-19
• Primary completion: 2023-11-07
• Completion: 2023-11-13
• First posted: 2023-10-23
• Last updated: 2024-12-03

Locations

1 site across 1 country: China