A Study of IBI351 in Healthy Subjects

An Open-label, 2-cycle Clinical Study to Evaluate the Drug Interaction Between Itraconazole or Dextromethorphan and IBI351 in Healthy Subjects

This is an open-label, two-cycle clinical study to evaluate the drug interaction between itraconazole or dextromethorphan and IBI351 in healthy subjects. A total of two cohorts of 12 healthy male subjects were planned to be enrolled in each cohort.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: Itraconazole; Drug: IBI351; Drug: Dextromethorphan

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China
      • The first affiliated hospital of suzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 in the range of 19 ~ 26 kg/m2 (including both ends).
4. Physical examination, vital signs, routine laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function), thyroid function, 12-lead electrocardiogram, chest CT, abdominal ultrasound (hepatobiliary, pancreatic, spleen and kidney), echocardiography (only applicable to Cohort 1 subjects) showed no abnormalities; or abnormal test results but judged as normal or clinically insignificant by the investigator.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: IBI351+ itraconazole; Enrolled subjects were treated with IBI351 on an empty stomach on Day 1. Itraconazole was administered orally once daily after a standardized meal from Day 3 to Day 6. IBI351 and itraconazole were administered simultaneously on an empty stomach on Day 7. On Day 8, itraconazole was orally administered once after a standard meal.	Drug: Itraconazole; Itraconazole was administered orally; Drug: IBI351; IBI351 was administered orally
Other: IBI351+ dextromethorphan; Enrolled subjects were orally administered dextromethorphan on an empty stomach on Day 1. IBI351 and dextromethorphan were orally administered simultaneously on an empty stomach on Day 3, followed by IBI351 12 hours later.	Drug: IBI351; IBI351 was administered orally; Drug: Dextromethorphan; Dextromethorphan was administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
maximum concentrations (Cmax ) for IBI351	approximately 10 days
maximum concentrations (Cmax ) for dextromethorphan	approximately 10 days
area under the curve from time 0 to infinity(AUC0-inf) for IBI351	approximately 10 days
area under the curve from time 0 to infinity(AUC0-inf) for dextromethorphan	approximately 10 days

Secondary Outcome Measures

Outcome Measure	Time Frame
time-to-maximum concentration (Tmax) for IBI351	approximately 10 days
half-life (t1/2) for IBI351	approximately 10 days
area under the curve from time 0 to time (AUC0-t) for IBI351	approximately 10 days
apparent clearance (CL/F) for IBI351	approximately 10 days
apparent volume of distribution(Vz/F) for IBI351	approximately 10 days
time-to-maximum concentration (Tmax) for dextromethorphan	approximately 10 days
half-life (t1/2) for dextromethorphan	approximately 10 days
area under the curve from time 0 to time (AUC0-t) for dextromethorphan	approximately 10 days
apparent clearance (CL/F) for dextromethorphan	approximately 10 days
apparent volume of distribution(Vz/F) for dextromethorphan	approximately 10 days
area under the curve for dextrorphan	approximately 10 days
maximum concentrations (Cmax ) for dextrorphan	approximately 10 days
number of participants with abnormal hematology tests	approximately 10 days
number of participants with abnormal chemistry parameters	approximately 10 days
number of participants with abnormal vital signs	approximately 10 days
number of participants with abnormal physical examination findings	approximately 10 days
number of participants with abnormal ECG readings	approximately 10 days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2023
• Primary Completion (Actual): October 16, 2023
• Study Completion (Actual): October 16, 2023

Study Registration Dates

• First Submitted: January 17, 2023
• First Submitted That Met QC Criteria: January 25, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Respiratory System Agents; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; Antitussive Agents; 14-alpha Demethylase Inhibitors; Dextromethorphan; Itraconazole
• Other Study ID Numbers: CIBI351P003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No