Clinical trial NCT05490316: A Study of IBI353 (Orismilast) in Chinese Healthy Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2022-08-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Time to Maximal Blood Concentration (Tmax) of IBI353 and its related metabolites.
timeFrame: Baseline through Day 21
measure: Maximal Concentration (Cmax) of IBI353 and its related metabolites.
timeFrame: Baseline through Day 21
measure: Area Under the Concentration Curve (AUC) of IBI353 and its related metabolites.
timeFrame: Baseline through Day 21
measure: Volume of Distribution (Vd/F) of IBI353 and its related metabolites.
timeFrame: Baseline through Day 21
measure: Half life time of IBI353 and its related metabolites.
timeFrame: Baseline through Day 21
measure: Clearance (CL/F) of IBI353 and its related metabolites.
timeFrame: Baseline through Day 21
measure: Accumulation Ratio of IBI353 and its related metabolites.
timeFrame: Baseline through Day 21
Secondary outcomes:
measure: 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.
timeFrame: Baseline through Day 28
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital Affiliated to Fudan University
state: Shanghai
Study officials:
References: