A Study of IBI351 in Healthy Subjects

Innovent Biologics (Suzhou) Co. Ltd.24 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy Subjects

Interventions

IBI351DRUG

IBI351 is administered orally

EsomeprazoleDRUG

Esomeprazole is administered orally

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

the First Affiliated Hospital of Suzhou University

Suzhou, Jiangsu, China