Clinical trial NCT05991362: A Phase I Study of GFH312 in Healthy Chinese Subjects
Official title: A Randomized, Double-blind, Placebo-controlled, Single-dose and Multiple-dose Study Evaluating the Pharmacokinetics and Safety of GFH312 in Healthy Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Genfleet Therapeutics (Shanghai) Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 of 120 mg GFH312, as well as their matching placebo. Subjects were randomized in 3:1 ratio in the single dose cohorts and in 4:1 ratio in the multiple dose cohort.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of GFH312
timeFrame: For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4.
measure: Time to peak drug concentration (Tmax) of GFH312
timeFrame: For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4.
measure: Terminal Elimination Half Life (t1/2) of GFH312
timeFrame: For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4; for multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.
measure: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of GFH312
timeFrame: For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4.
measure: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of GFH312
timeFrame: For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4.
measure: The apparent systemic (or total body) clearance from plasma (or serum or blood (CL/F) following extravascular administration of GFH312
timeFrame: For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4; for multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.
measure: The apparent volume of distribution during the terminal elimination phase (Vd/F) following extravascular administration of GFH312
timeFrame: For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4; for multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.
measure: The observed maximum plasma (or serum or blood) concentration following drug administration at steady state (Cmax,ss)
timeFrame: For multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.
measure: The lowest plasma (or serum or blood) concentration observed during a dosing interval at steady state (Cmin,ss)
timeFrame: For multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.
measure: Time to reach maximum concentration in the dosing interval at steady state (Tmax,ss)
timeFrame: For multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.
measure: The area under the plasma (or serum or blood) concentration-time curve from time zero to the end of the dosing interval tau (AUCtau,ss)
timeFrame: For multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.
Secondary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
timeFrame: up to 30 days after the last study drug administration
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Wuhan Union Hospital, China
name: LU Yongning, PHD
role: PRINCIPAL_INVESTIGATOR
References: