A Phase I Study of GFH312 in Healthy Chinese Subjects

GenFleet Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: GFH312 120mg; Drug: GFH312 200 mg; Other: Placebo; Drug: GFH312 100 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05991362

GFH312X1102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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26 participants in 4 patient groups, including a placebo group

SAD:100mg

Experimental group

Description:

Participants received single PO dose of GFH312 100 mg.

Treatment:

Drug: GFH312 100 mg

SAD:200mg

Experimental group

Description:

Participants received single PO dose of GFH312 200 mg.

Treatment:

Drug: GFH312 200 mg

MAD:120mg

Experimental group

Description:

Participants received multiple PO doses of GFH312 120 mg for 14 days.

Treatment:

Drug: GFH312 120mg

Placebo

Placebo Comparator group

Description:

Participants receiving placebo matching with the GFH312 dose groups

Treatment:

Other: Placebo