A Study of IBI351 in Healthy 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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-10

Study Completion Date

2023-10-16

Brief Summary

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This is an open-label, two-cycle clinical study to evaluate the drug interaction between itraconazole or dextromethorphan and IBI351 in healthy subjects. A total of two cohorts of 12 healthy male subjects were planned to be enrolled in each cohort.

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Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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IBI351+ itraconazole

Enrolled subjects were treated with IBI351 on an empty stomach on Day 1. Itraconazole was administered orally once daily after a standardized meal from Day 3 to Day 6. IBI351 and itraconazole were administered simultaneously on an empty stomach on Day 7. On Day 8, itraconazole was orally administered once after a standard meal.

Group Type OTHER

Itraconazole

Intervention Type DRUG

Itraconazole was administered orally

IBI351

Intervention Type DRUG

IBI351 was administered orally

IBI351+ dextromethorphan

Enrolled subjects were orally administered dextromethorphan on an empty stomach on Day 1. IBI351 and dextromethorphan were orally administered simultaneously on an empty stomach on Day 3, followed by IBI351 12 hours later.

Group Type OTHER

IBI351

Intervention Type DRUG

IBI351 was administered orally

Dextromethorphan

Intervention Type DRUG

Dextromethorphan was administered orally

Interventions

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Itraconazole

Itraconazole was administered orally

Intervention Type DRUG

IBI351

IBI351 was administered orally

Intervention Type DRUG

Dextromethorphan

Dextromethorphan was administered orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Voluntarily sign the informed consent form before the trial, fully understand the content, process and possible adverse reactions of the trial, and be able to complete the study according to the requirements of the trial protocol.
2. Healthy male subjects aged 18 to 45 years (including both ends) at the time of signing informed consent.
3. Body weight is not less than 50 kg, and body mass index (BMI) is in the range of 19 \~ 26 kg/m2 (including both ends).
4. Physical examination, vital signs, routine laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function), thyroid function, 12-lead electrocardiogram, chest CT, abdominal ultrasound (hepatobiliary, pancreatic, spleen and kidney), echocardiography (only applicable to Cohort 1 subjects) showed no abnormalities; or abnormal test results but judged as normal or clinically insignificant by the investigator.

Exclusion Criteria

1. have taken any products containing alcohol or have a positive alcohol breath test (≥ 20 mg/100 ml) within 24 hours before taking study medication.
2. hepatitis B surface antigen HBsAg positive.
3. hepatitis C virus antibody positive.
4. positive AIDS antigen/antibody or Treponema pallidum antibody.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes