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A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Dose Escalation of GS1-144 Tablets and the Effects of Food on the Pharmacokinetics of GS1-144 in a Chinese Population

NCT06385158 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-05-08

No results posted yet for this study

Summary

A Phase I clinical study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple oral dose escalation of GS1-144 tablets and the effects of food on the pharmacokinetics of GS1-144 in a Chinese population

Conditions

  • Vasomotor System; Labile
  • Healthy Volunteer

Interventions

DRUG

GS1-144 tablet

GS1-144 tablet is an NK3R antagonist.

Sponsors & Collaborators

  • Changchun GeneScience Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-03
Primary Completion
2024-01-06
Completion
2024-11-05

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06385158 on ClinicalTrials.gov