A Phase 1 interventional study of IBI351 and Esomeprazole in Healthy Subjects, sponsored by Innovent Biologics (Suzhou) Co. Ltd.. Completed at 1 site in China. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-24.
Sponsored by Innovent Biologics (Suzhou) Co. Ltd. · Phase 1, Interventional, and Other
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.
Innovent Biologics (Suzhou) Co. Ltd. is the lead sponsor of 192 studies on the registry; 44 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This cohort investigated the effect of food on the pharmacokinetics of IBI351 in healthy subjects. In a double-crossover design, subjects were enrolled and randomly divided into two test groups A and B. Group A: IBI351 was orally administered to subjects in this group on an empty stomach on Day 1, followed by a high-fat meal on Day 4. Group B: IBI351 was orally administered to subjects in this group after a high-fat meal on Day 1 followed by an empty stomach on Day 4.
Drug: IBI351
Enrolled subjects were orally administered IBI351 with recommended dose on an empty stomach. Esomeprazole were administered orally.
Drug: IBI351 · Drug: Esomeprazole
IBI351 is administered orally
Esomeprazole is administered orally
maximum concentrations (Cmax ) for plasma
Time frame: approximately 10 days after first dose
area under the curve from time 0 to infinity(AUC0-inf) for plasma
Time frame: approximately 10 days after first dose
area under the curve from time 0 to the last time point (AUC0-t) for plasma
Time frame: approximately 10 days after first dose
time-to-maximum concentration (Tmax) for total plasma
Time frame: approximately 10 days after first dose
half-life (t1/2) for total plasma
Time frame: approximately 10 days after first dose
apparent clearance (CL/F) for total plasma
Time frame: approximately 10 days after first dose
the time prior to the first measurable (non-zero) concentration （tlag）
Time frame: approximately 10 days after first dose
apparent volume of distribution(Vz/F) for total plasma
Time frame: approximately 10 days after first dose
adverse events
Time frame: approximately 10 days after first dose
number of participants with abnormal ECG readings
Time frame: approximately 10 days after first dose
number of participants with abnormal hematology test results
Time frame: approximately 10 days after first dose
number of participants with abnormal chemisty test results
Time frame: approximately 10 days after first dose
number of participants with abnormal vital signs
Time frame: approximately 10 days after first dose
number of participants with abnormal physical examination
Time frame: approximately 10 days after first dose
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Innovent Biologics (Suzhou) Co. Ltd.