Clinical trial NCT05688124: A Study of IBI351 in Healthy Subjects
Official title: A Randomized, Open-label, Two-cycle Clinical Study to Evaluate the Drug Interaction, Food Effect and Pharmacokinetics of IBI351 With Esomeprazole 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: 2023-01-18
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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 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

Primary outcomes:
measure: maximum concentrations (Cmax ) for plasma
timeFrame: approximately 10 days after first dose
measure: area under the curve from time 0 to infinity(AUC0-inf) for plasma
timeFrame: approximately 10 days after first dose
measure: area under the curve from time 0 to the last time point (AUC0-t) for plasma
timeFrame: approximately 10 days after first dose
Secondary outcomes:
measure: time-to-maximum concentration (Tmax) for total plasma
timeFrame: approximately 10 days after first dose
measure: half-life (t1/2) for total plasma
timeFrame: approximately 10 days after first dose
measure: apparent clearance (CL/F) for total plasma
timeFrame: approximately 10 days after first dose
measure: the time prior to the first measurable (non-zero) concentration （tlag）
timeFrame: approximately 10 days after first dose
measure: apparent volume of distribution(Vz/F) for total plasma
timeFrame: approximately 10 days after first dose
measure: adverse events
timeFrame: approximately 10 days after first dose
measure: number of participants with abnormal ECG readings
timeFrame: approximately 10 days after first dose
measure: number of participants with abnormal hematology test results
timeFrame: approximately 10 days after first dose
measure: number of participants with abnormal chemisty test results
timeFrame: approximately 10 days after first dose
measure: number of participants with abnormal vital signs
timeFrame: approximately 10 days after first dose
measure: number of participants with abnormal physical examination
timeFrame: approximately 10 days after first dose
Other outcomes:
Locations:
city: Suzhou
country: China
facility: the First Affiliated Hospital of Suzhou University
state: Jiangsu
Study officials:
References: