A Study of IBI351 in Healthy Subjects

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05699993
• Other study ID #: CIBI351P003
• Status: Completed
• Phase: Phase 1
• Start date: March 10, 2023
• Est. completion date: October 16, 2023

Study information

• Verified date: October 2023
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 16, 2023
• Est. primary completion date: October 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Itraconazole
Itraconazole was administered orally
• IBI351
IBI351 was administered orally
• Dextromethorphan
Dextromethorphan was administered orally

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Suzhou University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

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