A Study of IBI351 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: Itraconazole; Drug: IBI351; Drug: Dextromethorphan

• Registration Number: NCT05699993
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-01-17
• Study First Submitted QC: 2023-01-25
• Study First Posted: 2023-01-26
• Study Start: 2023-03-10
• Status Verified: 2023-10
• Primary Completion: 2023-10-16
• Study Completion: 2023-10-16
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IBI351+ itraconazole	IBI351	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.
IBI351+ dextromethorphan	IBI351	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.
IBI351+ dextromethorphan	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.
IBI351+ itraconazole	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
apparent volume of distribution(Vz/F) for IBI351	approximately 10 days
maximum concentrations (Cmax ) for dextrorphan	approximately 10 days
area under the curve for dextrorphan	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
number of participants with abnormal hematology tests	approximately 10 days
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
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

Trial Locations

Locations (1)

The First Affiliated Hospital of Suzhou University; 🇨🇳 Suzhou, Jiangsu, China