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Completed

NCT Number: NCT05921890

To Evaluate the Safety and Tolerability of Multiple Doses of GS3-007a Oral Solution in Healthy Subjects.

To evaluate the safety and tolerability of GS3-007a oral solution after multiple oral administration in Chinese healthy adult subjects.

Completed

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Key information

Conditions

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, Sichuan, 610000, China

About this study

To evaluate the pharmacodynamic (PD) and pharmacokinetics(PK) characteristics of GS3-007a oral solution after multiple oral administration in Chinese healthy adult subjects

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 or female;
  • Body mass index: 19-26 kg/m2 (including boundary values), male weight ≥50 kg, female weight ≥45 kg;

Exclusion criteria

  • (Screening period consultation) accumulated two or more allergies to other drugs, food and environment; Or prone to rash, urticaria and other allergic symptoms; Or are known to be allergic to growth hormone-promoting peptide drugs or excipients of this preparation;
  • (screening period) have a clear history of neurological or mental disorders; Persons with incapacity or cognitive impairment;
  • ALT and AST exceed the upper limit of the normal range;

Treatment and study plan

GS3-007 oral liquid

Drug

The dosage was calculated according to body weight, once a day or twice a day.

Primary outcomes

  1. TEAEs

    Time frame: 35 Days

Sponsors and collaborators

Lead sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

To Evaluate the Safety and Tolerability of GS3-007a Oral Solution in a Multi-dose, Randomized, Open, Single-center Study in Healthy Chinese Adult Subjects.

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 27, 2023
Registry last updated
Nov 9, 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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