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Clinical Trial Summary

The primary purpose of this study is to assess the safety and tolerability of single ascending doses of GS1-144 in healthy participants in Part 1 and to assess the safety and tolerability of multiple ascending doses of GS1-144 in healthy postmenopausal female participants in Part 2.


Clinical Trial Description

This study will be divided into two sequential parts: Part 1 single ascending dose (SAD), and Part 2 multiple ascending dose (MAD) with the overall design. Part 1 will enroll a total of approximately 38 healthy participants in five cohorts at 5 milligram (mg), 15 mg, 30 mg, 60 mg and 90 mg dose levels. Each cohort will have 2 participants receiving placebo. There is no restriction on the male-to female ratio. Part 2 will be conducted after confirming the safety and tolerability of the ->30mg dose in Part 1 and will enroll a total of approximately 30 healthy postmenopausal female participants and provisionally consists of three cohorts at 15 mg, 30 mg and 60 mg dose levels. Each cohort will have 2 participants receiving placebo. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06204250
Study type Interventional
Source Changchun GeneScience Pharmaceutical Co., Ltd.
Contact Fanny Hou
Phone 8618502191682
Email fanny.hou@syneoshealth.com
Status Recruiting
Phase Phase 1
Start date February 27, 2024
Completion date December 17, 2024

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