A Study of IBI353 (Orismilast) in Chinese Healthy Adults

NCT ID: NCT05490316

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-30
• Study Completion Date: 2022-12-30

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.

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo tablet

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo

IBI353 (Orismilast) dose 2

Group Type: EXPERIMENTAL

IBI353 (Orismilast)

Intervention Type: DRUG

dose 1 or dose 2

IBI353 (Orismilast) dose 1

Group Type: EXPERIMENTAL

IBI353 (Orismilast)

Intervention Type: DRUG

dose 1 or dose 2

Interventions

IBI353 (Orismilast)

dose 1 or dose 2

Intervention Type: DRUG

placebo

placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

CIBI353A101

Identifier Type: -

Identifier Source: org_study_id