Status:
COMPLETED
A Phase I Study of GFH312 in Healthy Chinese Subjects
Lead Sponsor:
Zhejiang Genfleet Therapeutics Co., Ltd.
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The aim of this study was to evaluate the pharmacokinetic profile and observe the safety of GFH312 after single and multiple administrations in healthy Chinese subjects.
Detailed Description
This study was planned to enroll about 26 healthy subjects, subjects were planned to receive single administration of 100 mg GFH312, single administration of 200 mg GFH312, or multiple administrations...
Eligibility Criteria
Inclusion
- Voluntarily participate in the study and sign the informed consent;
- Male or female healthy subjects aged 18-55 years (inclusive) (single sex ratio not less than 25% of the sample size of each cohort);
- Body mass index (BMI) between 18-28 kg/m2 (inclusive), and weight ≥ 50kg; BMI = Weight (kg) /\[Height (m)\]2.
- During the screening period and day 1, patients with normal or abnormal results but no clinical significance based on detailed medical history, comprehensive physical examination, laboratory examination (blood routine, blood biochemistry, urine routine, coagulation function), 12-lead electrocardiogram and vital signs.
- Able to communicate well with researchers, understand and comply with research requirements.
Exclusion
- Any procedure or disease that may significantly alter drug absorption, distribution, metabolism, or excretion, or participation in this study may compromise the safety of the subject.
- Tuberculin test positive
- Abnormal electrocardiogram with clinical significance
- Use any prescription drugs, Chinese herbs and/or OTC or health products within 2 weeks before starting the administration.
- Women who are pregnant or breastfeeding, or subjects with positive pregnancy test results at the time of screening or at baseline, or who plan to become pregnant during the study period or within 30 days after the end of the study.
- Subjects who have any factors deemed unsuitable for participation in this study by the investigator.
Key Trial Info
Start Date :
November 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2023
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT05991362
Start Date
November 29 2022
End Date
May 30 2023
Last Update
August 23 2023
Active Locations (1)
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1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China