Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040, China
NCT Number: NCT05490316
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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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Shanghai, Shanghai Municipality, 200040, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
dose 1 or dose 2
placebo
Time frame: Baseline through Day 21
Time frame: Baseline through Day 21
Time frame: Baseline through Day 21
Time frame: Baseline through Day 21
Time frame: Baseline through Day 21
Time frame: Baseline through Day 21
Time frame: Baseline through Day 21
Time frame: Baseline through Day 28
Innovent Biologics (Suzhou) Co. Ltd.
Industry
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
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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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