A Study of IBI353 (Orismilast) in Chinese Healthy Adults

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05490316

Enrollment

Registered

2022-08-05

Start date

2022-11-30

Completion date

2022-12-30

Last updated

2023-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

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.

Interventions

DRUGIBI353 (Orismilast)

dose 1 or dose 2

DRUGplacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Volume of Distribution (Vd/F) of IBI353 and its related metabolites.	Baseline through Day 21
Accumulation Ratio 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
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

Secondary

Measure	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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026