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Completed

NCT Number: NCT05490316

A Study of IBI353 (Orismilast) in Chinese Healthy Adults

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

IBI353 (Orismilast)

Drug

dose 1 or dose 2

Placebo

Drug

placebo

Primary outcomes

  1. Time to Maximal Blood Concentration (Tmax) of IBI353 and its related metabolites.

    Time frame: Baseline through Day 21

  2. Maximal Concentration (Cmax) of IBI353 and its related metabolites.

    Time frame: Baseline through Day 21

  3. Area Under the Concentration Curve (AUC) of IBI353 and its related metabolites.

    Time frame: Baseline through Day 21

  4. Volume of Distribution (Vd/F) of IBI353 and its related metabolites.

    Time frame: Baseline through Day 21

  5. Half life time of IBI353 and its related metabolites.

    Time frame: Baseline through Day 21

  6. Clearance (CL/F) of IBI353 and its related metabolites.

    Time frame: Baseline through Day 21

  7. Accumulation Ratio of IBI353 and its related metabolites.

    Time frame: 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.

    Time frame: Baseline through Day 28

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 5, 2022
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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