A Study of IBI353 (Orismilast) in Chinese Healthy Adults

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: placebo; Drug: IBI353 (Orismilast)

• Registration Number: NCT05490316
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-04
• Study First Submitted QC: 2022-08-04
• Study First Posted: 2022-08-05
• Study Start: 2022-11-30
• Primary Completion: 2022-11-30
• Study Completion: 2022-12-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-03
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo tablet	placebo	-
IBI353 (Orismilast) dose 2	IBI353 (Orismilast)	-
IBI353 (Orismilast) dose 1	IBI353 (Orismilast)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Huashan Hospital Affiliated to Fudan University; 🇨🇳 Shanghai, Shanghai, China