To Evaluate the Safety and Tolerability of Multiple Doses of GS3-007a Oral Solution in Healthy Subjects.
Phase 1
Completed
- Conditions
- Healthy Subject
- Interventions
- Drug: GS3-007 oral liquid
- Registration Number
- NCT05921890
- Lead Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Brief Summary
To evaluate the safety and tolerability of GS3-007a oral solution after multiple oral administration in Chinese healthy adult subjects.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GS3-007 oral liquid 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.
- Primary Outcome Measures
Name Time Method TEAEs 35 Days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Chengdu Xinhua Hospital Affiliated to North Sichuan Medical College
🇨🇳Chengdu, Sichuan, China