A Study of IBI351 in Healthy Subjects

A Randomized, Open-label, Two-cycle Clinical Study to Evaluate the Drug Interaction, Food Effect and Pharmacokinetics of IBI351 With Esomeprazole in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: IBI351; Drug: Esomeprazole

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Haiyan Zhu; Phone Number: 0512-69566088; Email: haiyan.zhu@innoventbio.com

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215006
      • The first affiliated hospital of suzhou University
      • Contact: liyan Miao; Phone Number: +86 15151452656; Email: sdfyy8040@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: IBI351; 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; IBI351 is administered orally
Other: IBI351+Esomeprazole; Enrolled subjects were orally administered IBI351 with recommended dose on an empty stomach. Esomeprazole were administered orally.	Drug: IBI351; IBI351 is administered orally; Drug: Esomeprazole; Esomeprazole is administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
area under the curve from time 0 to the last time point (AUC0-t) for plasma	approximately 10 days after first dose

Secondary Outcome Measures

Outcome Measure	Time Frame
time-to-maximum concentration (Tmax) for total plasma	approximately 10 days after first dose
half-life (t1/2) for total plasma	approximately 10 days after first dose
apparent clearance (CL/F) for total plasma	approximately 10 days after first dose
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
number of participants with abnormal hematology test results	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

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2023
• Primary Completion (Actual): October 16, 2023
• Study Completion (Actual): October 16, 2023

Study Registration Dates

• First Submitted: December 12, 2022
• First Submitted That Met QC Criteria: January 13, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole
• Other Study ID Numbers: CIBI351P001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No