A Study of IBI353 (Orismilast) in Chinese Healthy Adults

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: IBI353 (Orismilast)
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or female 18 to 45 years of age at the time of consent BMI of 19-27Kg/m2 and weight of 50-100kg (male) or 45-100kg (female) Participants are in good health condition at screening stage based on past history, lab tests, EEG, physical examinations, and vital signs. 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: Subjects who have a medical history of liver, kidney, cardiovascular, nervous / mental, gastrointestinal, respiratory, urinary, endocrine system; Subjects who have a history of relapse or chronic infection, or a history of acute infection treated by antibiotics within 3 months; Subjects who have previously used PDE4 inhibitor dugs; Subjects who have clinically significant abnormalities determined by vital signs, physical examination, and laboratory measurements; Subjects who are not suitable for this trial due to other reasons In the investigator' opinion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo tablet<br> | Drug: placebo<br>* placebo<br>|
| Experimental: IBI353 (Orismilast) dose 2<br> | Drug: IBI353 (Orismilast)<br>* dose 1 or dose 2<br>|
| Experimental: IBI353 (Orismilast) dose 1<br> | Drug: IBI353 (Orismilast)<br>* dose 1 or dose 2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |