NCT06204250

A Study to Assess Safety and Tolerability of GS1-144 in Healthy Volunteers

A Phase 1 Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of GS1-144 Tablets

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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 46 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 60 mg and 120mg dose levels. Each cohort will have 2 participants receiving placebo.

Conditions

• Vasomotor Symptoms
• Adult Healthy Volunteers

Interventions

Type	Name	Description
DRUG	GS1-144	Oral tablets.
DRUG	Placebo	Matching placebo tablets.

Timeline

• Start date: 2024-02-27
• Primary completion: 2024-12-19
• Completion: 2024-12-19
• First posted: 2024-01-12
• Last updated: 2025-02-17

Locations

1 site across 1 country: Australia