Healthy Subject Clinical Trial
Official title:
Phase I Randomized, Double-blind, Placebo-controlled, Single Multiple Dosing, Dose Escalation, and Food Effect Study of GS3-007A Oral Liquid in Chinese Healthy Adults
Verified date | October 2022 |
Source | GeneScience Pharmaceuticals Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the safety and tolerability of GS3-007A in single, multiple, and single oral administration after high-fat meals in Chinese healthy adults.
Status | Completed |
Enrollment | 96 |
Est. completion date | April 1, 2023 |
Est. primary completion date | April 1, 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 and female; - Body mass index: 19-26 kg/m2 (including boundary value), male weight =50 kg, female weight =45 kg; Exclusion Criteria: - Patients with a history of substance abuse and substance dependence; - Family history of sudden death; |
Country | Name | City | State |
---|---|---|---|
China | Chengdu Xinhua Hospital Affiliated to North Sichuan Medical College | Chengdu | Chengdu |
Lead Sponsor | Collaborator |
---|---|
GeneScience Pharmaceuticals Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | TEAEs | Adverse events during treatment:Number of participants with treatment-related adverse events as assessed by Guidelines for NIA adverse Events and Serious Adverse Events , To evaluate the safety and tolerability of GS3-007A in single, multiple, and single oral administration after high-fat meals in Chinese healthy adults. | Part 1:Changes in safety data from baseline 3 days after dosing; Part 2:Changes in safety data from baseline 10 days after dosing; Part 3:Changes in safety data from baseline 6 days after dosing; | |
Secondary | PK characteristics | To evaluate the pharmacokinetic (Peak Plasma Concentration (Cmax)) characteristics of GS3-007A in Chinese healthy adults after single, multiple, and single oral administration of high-fat meals. | Part 1: Values measured at baseline and within 3 days after dosing; Part 2: Values measured at baseline and within 10days after dosing; Part 3: Values measured at baseline and within 6 days after dosing; |
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