A Study of IBI353 (Orismilast) in Chinese Healthy Adults

NCT05490316 | Completed Phase 1

• 1 other identifier: CIBI353A101
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (1)

• 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

Study Arms (3)

Placebo tablet

PLACEBO COMPARATOR

Drug: placebo

IBI353 (Orismilast) dose 2

EXPERIMENTAL

Drug: IBI353 (Orismilast)

IBI353 (Orismilast) dose 1

EXPERIMENTAL

Drug: IBI353 (Orismilast)

Interventions

IBI353 (Orismilast) DRUG

dose 1 or dose 2

IBI353 (Orismilast) dose 1; IBI353 (Orismilast) dose 2

placebo DRUG

placebo

Placebo tablet

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female 18 to 45 years of age at the time of consent
• BMI of 19-27Kg/m2 and weight of 50-100kg (male) or 45-100kg (female)
• Participants are in good health condition at screening stage based on past history, lab tests, EEG, physical examinations, and vital signs.
• 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

You may not qualify if:

• Subjects who have a medical history of liver, kidney, cardiovascular, nervous / mental, gastrointestinal, respiratory, urinary, endocrine system;
• Subjects who have a history of relapse or chronic infection, or a history of acute infection treated by antibiotics within 3 months;
• Subjects who have previously used PDE4 inhibitor dugs;
• Subjects who have clinically significant abnormalities determined by vital signs, physical examination, and laboratory measurements;
• Subjects who are not suitable for this trial due to other reasons In the investigator' opinion

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 5, 2022
• Study Start: November 30, 2022
• Primary Completion: November 30, 2022
• Study Completion: December 30, 2022
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)