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 in a Multi-dose, Randomized, Open, Single-center Study in Healthy Chinese Adult Subjects.

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

Study Overview

• Status: Completed
• Conditions: Healthy Subject
• Intervention / Treatment: Drug: GS3-007 oral liquid

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yu Yue; Phone Number: +86 18796217773; Email: yueyu@gensci-china.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • Chengdu Xinhua Hospital affiliated to North Sichuan Medical College
      • Contact: Xiaolan Yong; Phone Number: +86-28-60212136; Email: yongxlan@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GS3-007 oral liquid; 36 subjects，12 subjects in each dose group. Two dose groups were planned: 0.8 mg/kg and 1.6 mg/kg once a day for 4 weeks. According to the research progress of 1.6mg/kg QD, it was decided whether to add 0.8 mg/kg twice a day for 4 weeks.	Drug: GS3-007 oral liquid; The dosage was calculated according to body weight, once a day or twice a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
TEAEs	35 Days

Collaborators and Investigators

• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2023
• Primary Completion (Actual): October 28, 2023
• Study Completion (Actual): October 28, 2023

Study Registration Dates

• First Submitted: June 16, 2023
• First Submitted That Met QC Criteria: June 16, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 8, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: GenSci073-104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No