A Study of IBI351 in Healthy Subjects

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05688124
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 3.8
• Patients Per Site Per Month: 6.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Drug: IBI351; Drug: Esomeprazole	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Anticipated Study Start Date: Feb 6, 2023
• Anticipated Primary Completion Date: Apr 27, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. maximum concentrations (Cmax ) for plasma [approximately 10 days after first dose]

2. area under the curve from time 0 to infinity(AUC0-inf) for plasma [approximately 10 days after first dose]

3. 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

1. time-to-maximum concentration (Tmax) for total plasma [approximately 10 days after first dose]

2. half-life (t1/2) for total plasma [approximately 10 days after first dose]

3. apparent clearance (CL/F) for total plasma [approximately 10 days after first dose]

4. the time prior to the first measurable (non-zero) concentration （tlag） [approximately 10 days after first dose]

5. apparent volume of distribution(Vz/F) for total plasma [approximately 10 days after first dose]

6. adverse events [approximately 10 days after first dose]

7. number of participants with abnormal ECG readings [approximately 10 days after first dose]

8. number of participants with abnormal hematology test results [approximately 10 days after first dose]

9. number of participants with abnormal chemisty test results [approximately 10 days after first dose]

10. number of participants with abnormal vital signs [approximately 10 days after first dose]

11. number of participants with abnormal physical examination [approximately 10 days after first dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	the First Affiliated Hospital of Suzhou University	Suzhou	Jiangsu	China	215006

Sponsors and Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Innovent Biologics (Suzhou) Co. Ltd.
• ClinicalTrials.gov Identifier: NCT05688124
• Other Study ID Numbers: CIBI351P001
• First Posted: Jan 18, 2023
• Last Update Posted: Jan 18, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Esomeprazole

Study Results

No Results Posted as of Jan 18, 2023