A Study of IBI351 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: IBI351; Drug: Esomeprazole

• Registration Number: NCT05688124
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-12-12
• Study First Submitted QC: 2023-01-13
• Study First Posted: 2023-01-18
• Study Start: 2023-02-16
• Status Verified: 2023-10
• Primary Completion: 2023-10-16
• Study Completion: 2023-10-16
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IBI351+Esomeprazole	IBI351	Enrolled subjects were orally administered IBI351 with recommended dose on an empty stomach. Esomeprazole were administered orally.
IBI351+Esomeprazole	Esomeprazole	Enrolled subjects were orally administered IBI351 with recommended dose on an empty stomach. Esomeprazole were administered orally.
IBI351	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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 physical examination	approximately 10 days after first dose

Trial Locations

Locations (1)

the First Affiliated Hospital of Suzhou University; 🇨🇳 Suzhou, Jiangsu, China