The goal of this clinical trial is to evaluate the safety and tolerability of QX-453, an investigational treatment, in healthy Chinese volunteers and patients with moderate-to-severe atopic dermatitis. The study will assess how the drug is absorbed and processed by the body, and check for any side effects. Participants will receive single or repeated oral doses of QX-453 under close medical supervision, with regular safety and clinical assessments throughout the trial.
Fully understanding the purpose, nature, method, and possible adverse reactions of the trial, voluntarily participating as a clinical trial participant, and signing the ICF;
Being willing and able to comply with the study protocol and cooperate in completing the visit procedures throughout the study;
Males and females aged 18 to 55 years (inclusive, at the time of signing the ICF) at screening;
Body mass index (BMI) of 18 to 28 kg/m2 (inclusive); weight not less than 50 kg for male and 45 kg for female;
Participants who are mentally or legally incapacitated, have a history of psychosis, or have significant emotional or psychological problems at the time of the study according to the Investigator;
Participants with dysphagia, oesophageal stenosis, or gastrointestinal diseases that cause clinically significant symptoms such as nausea, vomiting, diarrhoea, or malabsorption syndrome, or with a history of severe vomiting or diarrhoea within one week before the screening period;
Participants who have previously undergone surgeries that the Investigator deems may affect drug absorption, distribution, metabolism, or excretion (e.g., gastrectomy, cholecystectomy, gastric bypass, duodenal resection, colectomy);
Participants with a history of any ongoing medical condition requiring treatment with prescription medication within two weeks prior to screening;
Parallel
QX4533
DrugQX-4533, an oral investigational drug, administered as oral tablets in single or repeated dose escalation schedules for moderate-to-severe atopic dermatitis patients and healthy volunteers
QX4533 Placebo
DrugQX-4533 placebo, an oral investigational drug, administered as oral tablets in single or repeated dose escalation schedules for moderate-to-severe atopic dermatitis patients and healthy volunteers
Incidence of Treatment-emergent Adverse Events (TEAEs)
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Number of Participants with Clinically Significant Laboratory Parameter Changes
Number of Participants with Clinically Significant Change from Baseline in Clinical Laboratory Parameters
Maximum Observed Plasma Concentration (Cmax)
Time of the Maximum Measured Concentration (Tmax)
Area Under the Concentration-Time Curve from Time Zero to the Last Quantifiable concentration-time point (AUClast)
Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUCinf)
Change from Baseline in Eczema Area and Severity Index (EASI) Total Score
Change from Baseline in Investigator's Global Assessment (IGA) Score
Change from Baseline in Percentage of Body Surface Area (BSA) Affected by Atopic Dermatitis
Change from Baseline in SCORing Atopic Dermatitis (SCORAD) Total Score
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