A Study of IBI351 in Healthy Subjects

NCT05688124 | Completed Phase 1

• 1 other identifier: CIBI351P001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• 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

Study Arms (2)

IBI351

OTHER

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+Esomeprazole

OTHER

Enrolled subjects were orally administered IBI351 with recommended dose on an empty stomach. Esomeprazole were administered orally.

Drug: IBI351; Drug: Esomeprazole

Interventions

IBI351 DRUG

IBI351 is administered orally

IBI351; IBI351+Esomeprazole

Esomeprazole DRUG

Esomeprazole is administered orally

IBI351+Esomeprazole

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• healthy male subjects aged 18 to 45 years (including both ends) at the time of signing informed consent.
• 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).

You may not qualify if:

• have taken any products containing alcohol or have a positive alcohol breath test (≥ 20 mg/100 ml) within 24 hours before taking study medication.
• hepatitis B surface antigen HBsAg positive.
• hepatitis C virus antibody positive.
• positive AIDS antigen/antibody or Treponema pallidum antibody

Sponsors & Collaborators

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

Study Sites (1)

the First Affiliated Hospital of Suzhou University

Suzhou, Jiangsu, 215006, China

Location

MeSH Terms

Interventions

Esomeprazole

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: January 18, 2023
• Study Start: February 16, 2023
• Primary Completion: October 16, 2023
• Study Completion: October 16, 2023
• Last Updated: October 24, 2023

Record last verified: 2023-10

Locations

CN (1)