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

NCT05921890 | Completed Phase 1

• 1 other identifier: GenSci073-104
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Subject

Outcome Measures

Primary Outcomes (1)

• TEAEs

  35 Days

Study Arms (1)

GS3-007 oral liquid

EXPERIMENTAL

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

Interventions

GS3-007 oral liquid DRUG

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

GS3-007 oral liquid

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• (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;

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Chengdu Xinhua Hospital Affiliated to North Sichuan Medical College

Chengdu, Sichuan, 610000, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: June 27, 2023
• Study Start: June 19, 2023
• Primary Completion: October 28, 2023
• Study Completion: October 28, 2023
• Last Updated: November 9, 2023

Record last verified: 2023-06

Locations

CN (1)