A Study of IBI353 (Orismilast) in Chinese Healthy Adults

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05490316
• Other study ID #: CIBI353A101
• Status: Completed
• Phase: Phase 1
• Start date: November 30, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: May 2023
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• IBI353 (Orismilast)
dose 1 or dose 2
• placebo
placebo

Locations

Country	Name	City	State
China	Huashan Hospital Affiliated to Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

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