Healthy Subjects
Conditions
Brief summary
This is a randomized, open-label, two-cycle clinical study to evaluate the drug interaction, food effect and pharmacokinetics of IBI351 and esomeprazole in healthy subjects. A total of two cohorts were planned to be enrolled in each cohort. Cohort 1: This cohort investigated the effect of esomeprazole on the pharmacokinetics of IBI351 in healthy subjects. Cohort 2: This cohort investigated the effect of food on the pharmacokinetics of IBI351 in healthy subjects.
Interventions
DRUGIBI351
IBI351 is administered orally
DRUGEsomeprazole
Esomeprazole is administered orally
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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 within the range of 19 \ 26 kg/m2 (including cut-off value).
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| area under the curve from time 0 to the last time point (AUC0-t) for plasma | approximately 10 days after first dose |
| maximum concentrations (Cmax ) for plasma | approximately 10 days after first dose |
| area under the curve from time 0 to infinity(AUC0-inf) for plasma | approximately 10 days after first dose |
Secondary
| Measure | Time frame |
|---|---|
| the time prior to the first measurable (non-zero) concentration （tlag） | approximately 10 days after first dose |
| apparent volume of distribution(Vz/F) for total plasma | approximately 10 days after first dose |
| adverse events | approximately 10 days after first dose |
| number of participants with abnormal ECG readings | approximately 10 days after first dose |
| half-life (t1/2) for total plasma | approximately 10 days after first dose |
| number of participants with abnormal chemisty test results | approximately 10 days after first dose |
| number of participants with abnormal vital signs | approximately 10 days after first dose |
| number of participants with abnormal physical examination | approximately 10 days after first dose |
| number of participants with abnormal hematology test results | approximately 10 days after first dose |
| time-to-maximum concentration (Tmax) for total plasma | approximately 10 days after first dose |
| apparent clearance (CL/F) for total plasma | approximately 10 days after first dose |
Countries
China
Outcome results
None listed