Clinical trial NCT05699993: A Study of IBI351 in Healthy Subjects
Official title: An Open-label, 2-cycle Clinical Study to Evaluate the Drug Interaction Between Itraconazole or Dextromethorphan and IBI351 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2023-01-26
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: maximum concentrations (Cmax ) for IBI351
timeFrame: approximately 10 days
measure: maximum concentrations (Cmax ) for dextromethorphan
timeFrame: approximately 10 days
measure: area under the curve from time 0 to infinity(AUC0-inf) for IBI351
timeFrame: approximately 10 days
measure: area under the curve from time 0 to infinity(AUC0-inf) for dextromethorphan
timeFrame: approximately 10 days
Secondary outcomes:
measure: time-to-maximum concentration (Tmax) for IBI351
timeFrame: approximately 10 days
measure: half-life (t1/2) for IBI351
timeFrame: approximately 10 days
measure: area under the curve from time 0 to time (AUC0-t) for IBI351
timeFrame: approximately 10 days
measure: apparent clearance (CL/F) for IBI351
timeFrame: approximately 10 days
measure: apparent volume of distribution(Vz/F) for IBI351
timeFrame: approximately 10 days
measure: time-to-maximum concentration (Tmax) for dextromethorphan
timeFrame: approximately 10 days
measure: half-life (t1/2) for dextromethorphan
timeFrame: approximately 10 days
measure: area under the curve from time 0 to time (AUC0-t) for dextromethorphan
timeFrame: approximately 10 days
measure: apparent clearance (CL/F) for dextromethorphan
timeFrame: approximately 10 days
measure: apparent volume of distribution(Vz/F) for dextromethorphan
timeFrame: approximately 10 days
measure: area under the curve for dextrorphan
timeFrame: approximately 10 days
measure: maximum concentrations (Cmax ) for dextrorphan
timeFrame: approximately 10 days
measure: number of participants with abnormal hematology tests
timeFrame: approximately 10 days
measure: number of participants with abnormal chemistry parameters
timeFrame: approximately 10 days
measure: number of participants with abnormal vital signs
timeFrame: approximately 10 days
measure: number of participants with abnormal physical examination findings
timeFrame: approximately 10 days
measure: number of participants with abnormal ECG readings
timeFrame: approximately 10 days
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Suzhou University
state: Jiangsu
Study officials:
References: