A Study of IBI351 in Healthy Subjects

Study Overview
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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.

Official Title
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An Open-label, 2-cycle Clinical Study to Evaluate the Drug Interaction Between Itraconazole or Dextromethorphan and IBI351 in Healthy Subjects

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: Itraconazole
* Drug: IBI351
* Drug: Dextromethorphan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Healthy male subjects aged 18 to 45 years (including both ends) at the time of signing informed consent. 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). 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: have taken any products containing alcohol or have a positive alcohol breath test (≥ 20 mg/100 ml) within 24 hours before taking study medication. hepatitis B surface antigen HBsAg positive. hepatitis C virus antibody positive. positive AIDS antigen/antibody or Treponema pallidum antibody.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: IBI351+ itraconazole<br>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. | Drug: Itraconazole<br>* Itraconazole was administered orally<br>Drug: IBI351<br>* IBI351 was administered orally<br>|
| Other: IBI351+ dextromethorphan<br>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. | Drug: IBI351<br>* IBI351 was administered orally<br>Drug: Dextromethorphan<br>* Dextromethorphan was administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum concentrations (Cmax ) for IBI351 |  | approximately 10 days | 
| maximum concentrations (Cmax ) for dextromethorphan |  | approximately 10 days | 
| area under the curve from time 0 to infinity(AUC0-inf) for IBI351 |  | approximately 10 days | 
| area under the curve from time 0 to infinity(AUC0-inf) for dextromethorphan |  | approximately 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time-to-maximum concentration (Tmax) for IBI351 |  | approximately 10 days | 
| half-life (t1/2) for IBI351 |  | approximately 10 days | 
| area under the curve from time 0 to time (AUC0-t) for IBI351 |  | approximately 10 days | 
| apparent clearance (CL/F) for IBI351 |  | approximately 10 days | 
| apparent volume of distribution(Vz/F) for IBI351 |  | approximately 10 days | 
| time-to-maximum concentration (Tmax) for dextromethorphan |  | approximately 10 days | 
| half-life (t1/2) for dextromethorphan |  | approximately 10 days | 
| area under the curve from time 0 to time (AUC0-t) for dextromethorphan |  | approximately 10 days | 
| apparent clearance (CL/F) for dextromethorphan |  | approximately 10 days | 
| apparent volume of distribution(Vz/F) for dextromethorphan |  | approximately 10 days | 
| area under the curve for dextrorphan |  | approximately 10 days | 
| maximum concentrations (Cmax ) for dextrorphan |  | approximately 10 days | 
| number of participants with abnormal hematology tests |  | approximately 10 days | 
| number of participants with abnormal chemistry parameters |  | approximately 10 days | 
| number of participants with abnormal vital signs |  | approximately 10 days | 
| number of participants with abnormal physical examination findings |  | approximately 10 days | 
| number of participants with abnormal ECG readings |  | approximately 10 days |