A Study of IBI351 in Healthy Subjects

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05688124
• Other study ID #: CIBI351P001
• Status: Completed
• Phase: Phase 1
• Start date: February 16, 2023
• Est. completion date: October 16, 2023

Study information

• Verified date: October 2023
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 16, 2023
• Est. primary completion date: October 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• IBI351
IBI351 is administered orally
• Esomeprazole
Esomeprazole is administered orally

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Suzhou University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximum concentrations (Cmax ) for plasma		approximately 10 days after first dose
Primary	area under the curve from time 0 to infinity(AUC0-inf) for plasma		approximately 10 days after first dose
Primary	area under the curve from time 0 to the last time point (AUC0-t) for plasma		approximately 10 days after first dose
Secondary	time-to-maximum concentration (Tmax) for total plasma		approximately 10 days after first dose
Secondary	half-life (t1/2) for total plasma		approximately 10 days after first dose
Secondary	apparent clearance (CL/F) for total plasma		approximately 10 days after first dose
Secondary	the time prior to the first measurable (non-zero) concentration (tlag)		approximately 10 days after first dose
Secondary	apparent volume of distribution(Vz/F) for total plasma		approximately 10 days after first dose
Secondary	adverse events		approximately 10 days after first dose
Secondary	number of participants with abnormal ECG readings		approximately 10 days after first dose
Secondary	number of participants with abnormal hematology test results		approximately 10 days after first dose
Secondary	number of participants with abnormal chemisty test results		approximately 10 days after first dose
Secondary	number of participants with abnormal vital signs		approximately 10 days after first dose
Secondary	number of participants with abnormal physical examination		approximately 10 days after first dose