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

Healthy Subject Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05921890
• Other study ID #: GenSci073-104
• Status: Completed
• Phase: Phase 1
• Start date: June 19, 2023
• Est. completion date: October 28, 2023

Study information

• Verified date: June 2023
• Source: Changchun GeneScience Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 28, 2023
• Est. primary completion date: October 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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;

Related Conditions & MeSH terms

• Healthy Subject

Intervention

Drug:
• GS3-007 oral liquid
The dosage was calculated according to body weight, once a day or twice a day.

Locations

Country	Name	City	State
China	Chengdu Xinhua Hospital Affiliated to North Sichuan Medical College	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Changchun GeneScience Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TEAEs		35 Days