A Phase I Study of GFH312 in Healthy Chinese Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-29

Study Completion Date

2023-05-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SAD:100mg

Participants received single PO dose of GFH312 100 mg.

Group Type EXPERIMENTAL

GFH312 100 mg

Intervention Type DRUG

Participants receive single dose of GFH312 100 mg orally

SAD:200mg

Participants received single PO dose of GFH312 200 mg.

Group Type EXPERIMENTAL

GFH312 200 mg

Intervention Type DRUG

Participants receive single dose of GFH312 200 mg orally

MAD:120mg

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

Group Type EXPERIMENTAL

GFH312 120mg

Intervention Type DRUG

Participants receive daily dose of GFH312 120mg orally for fourteen consecutive days

Placebo

Participants receiving placebo matching with the GFH312 dose groups

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Participants receive placebo matching with GFH312

Interventions

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GFH312 100 mg

Participants receive single dose of GFH312 100 mg orally

Intervention Type DRUG

GFH312 200 mg

Participants receive single dose of GFH312 200 mg orally

Intervention Type DRUG

GFH312 120mg

Participants receive daily dose of GFH312 120mg orally for fourteen consecutive days

Intervention Type DRUG

Placebo

Participants receive placebo matching with GFH312

Intervention Type OTHER

Other Intervention Names

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GFH312 GFH312 GFH312

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes