A Study of IBI353 (Orismilast) in Chinese Healthy Adults

A Phase I Randomized, Double-Blind, Placebo-Controlled, Multiple Oral Dose Trial to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of IBI353 (Orismilast) in Healthy Subjects

This is a first in Chinese population study to evaluate the safety, tolerability, PK and PD of multiple dose of modified-release IBI353 administered orally in healthy subjects. The study enrolls 20 healthy subjects and consists of 1 week of screening, 3 weeks of treatment period and 1 week of safety follow up after completion of last dose.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: placebo; Drug: IBI353 (Orismilast)

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jing Zhang; Phone Number: 086-13816357098; Email: 13816357098@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Huashan Hospital affiliated to Fudan University
      • Contact: Jing Zhang; Phone Number: 086-13816357098; Email: 13816357098@163.com
      • Contact: Guoying Cao; Email: sherley_76@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Healthy male or female 18 to 45 years of age at the time of consent
2. BMI of 19-27Kg/m2 and weight of 50-100kg (male) or 45-100kg (female)
3. Participants are in good health condition at screening stage based on past history, lab tests, EEG, physical examinations, and vital signs.
4. Must provide written informed consent, and in the investigator's opinion, subject is able to understand the nature of the study and any risks involved in participation, and willing to cooperate and comply with the protocol restrictions and requirements

Exclusion Criteria:

1. Subjects who have a medical history of liver, kidney, cardiovascular, nervous / mental, gastrointestinal, respiratory, urinary, endocrine system;
2. Subjects who have a history of relapse or chronic infection, or a history of acute infection treated by antibiotics within 3 months;
3. Subjects who have previously used PDE4 inhibitor dugs;
4. Subjects who have clinically significant abnormalities determined by vital signs, physical examination, and laboratory measurements;
5. Subjects who are not suitable for this trial due to other reasons In the investigator' opinion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo tablet	Drug: placebo; placebo
Experimental: IBI353 (Orismilast) dose 2	Drug: IBI353 (Orismilast); dose 1 or dose 2
Experimental: IBI353 (Orismilast) dose 1	Drug: IBI353 (Orismilast); dose 1 or dose 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to Maximal Blood Concentration (Tmax) of IBI353 and its related metabolites.	Baseline through Day 21
Maximal Concentration (Cmax) of IBI353 and its related metabolites.	Baseline through Day 21
Area Under the Concentration Curve (AUC) of IBI353 and its related metabolites.	Baseline through Day 21
Volume of Distribution (Vd/F) of IBI353 and its related metabolites.	Baseline through Day 21
Half life time of IBI353 and its related metabolites.	Baseline through Day 21
Clearance (CL/F) of IBI353 and its related metabolites.	Baseline through Day 21
Accumulation Ratio of IBI353 and its related metabolites.	Baseline through Day 21

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of treatment-emergent adverse events (TEAEs), gastrointestinal AEs, and changes of vital signs, lab examinations, physical examinations, ECGs in healthy subjects after drug administration.	Baseline through Day 28

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2022
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: August 4, 2022
• First Submitted That Met QC Criteria: August 4, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CIBI353A101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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