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Completed

NCT Number: NCT05611281

GS3-007a Oral Solution in Healthy Subjects

To evaluate the safety and tolerability of GS3-007A in single, multiple, and single oral administration after high-fat meals in Chinese healthy adults.

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Key information

Conditions

Healthy Subject

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chengdu Xinhua Hospital Affiliated to North Sichuan Medical College

Chengdu, 610000, China

About this study

This is a first-in-human, The major aims of the study are to define the safety profile of this new drug, and to determine a recommended

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adult subjects aged 18-45 years (including boundary values), male and female;
  • Body mass index: 19-26 kg/m2 (including boundary value), male weight ≥50 kg, female weight ≥45 kg;

Exclusion criteria

  • Patients with a history of substance abuse and substance dependence;
  • Family history of sudden death;

Treatment and study plan

GS3-007 oral liquid or Placebo GS3-007 oral liquid oral medication

Drug

The dosage was calculated according to body weight and dose group once a day according to the assigned group.

Primary outcomes

  1. TEAEs

    Time frame: Part 1:Changes in safety data from baseline 3 days after dosing; Part 2:Changes in safety data from baseline 10 days after dosing; Part 3:Changes in safety data from baseline 6 days after dosing;

    Adverse events during treatment：Number of participants with treatment-related adverse events as assessed by Guidelines for NIA adverse Events and Serious Adverse Events , To evaluate the safety and tolerability of GS3-007A in single, multiple, and single oral administration after high-fat meals in Chinese healthy adults.

Secondary outcomes

  1. PK characteristics

    Time frame: Part 1: Values measured at baseline and within 3 days after dosing; Part 2: Values measured at baseline and within 10days after dosing; Part 3: Values measured at baseline and within 6 days after dosing;

    To evaluate the pharmacokinetic (Peak Plasma Concentration (Cmax)) characteristics of GS3-007A in Chinese healthy adults after single, multiple, and single oral administration of high-fat meals.

Sponsors and collaborators

Lead sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

Phase I Randomized, Double-blind, Placebo-controlled, Single Multiple Dosing, Dose Escalation, and Food Effect Study of GS3-007A Oral Liquid in Chinese Healthy Adults

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 10, 2022
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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