The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of IBI356 in Healthy Participants and in Atopic Dermatitis Patients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
99
Receive IBI356 in a multiple dose.
Active comparator
Receive IBI356 in a single dose.
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, China
Occurrence of Adverse Event (AE) in SAD study.
Time frame: Baseline to Week 20
Occurrence of Adverse Event (AE) in MAD study.
Time frame: Baseline to Week 36
Occurrence of Serious Adverse Event (SAE) in SAD study.
Time frame: Baseline to Week 20
Occurrence of Serious Adverse Event (SAE) in MAD study.
Time frame: Baseline to Week 36
Changes in blood pressure mmHg (as a measure of safety and tolerability) in SAD study.
Time frame: Baseline to Week 20
Changes in blood pressure mmHg (as a measure of safety and tolerability) in MAD study.
Time frame: Baseline to Week 36
Changes in respiratory rate measured as breaths per minute (as a measure of safety and tolerability) in SAD study.
Time frame: Baseline to Week 20
Changes in respiratory rate measured as breaths per minute (as a measure of safety and tolerability) in MAD study.
Time frame: Baseline to Week 36
Changes in heart rate bpm (as a measure of safety and tolerability) in SAD study.
Time frame: Baseline to Week 20
Changes in heart rate bpm (as a measure of safety and tolerability) in MAD study.
Time frame: Baseline to Week 36
Changes in tympanic temperature °C in SAD study.
Time frame: Baseline to Week 20
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Receive placebo in a single dose.
Receive placebo in a multiple dose.
Changes in tympanic temperature °C in MAD study.
Time frame: Baseline to Week 36
Changes in electrocardiograms PR, QR, QRS and QT intervals (as a measure of safety and tolerability) in SAD study.
Time frame: Baseline to Week 20
Changes in electrocardiograms PR, QR, QRS and QT intervals (as a measure of safety and tolerability) in MAD study.
Time frame: Baseline to Week 36
Area under the concentration time curve from time 0 to last observation (AUC 0-t).
Time frame: Baseline to Week 16
Maximum observed concentration (Cmax) after infusion.
Time frame: Baseline to Week 16
Systemic clearance after infusion (CL).
Time frame: Baseline to Week 16
Volume of distribution during the terminal phase after infusion(Apparent volume of distribution, V).
Time frame: Baseline to Week 16
Elimination half-life during the terminal phase after infusion(Half-life, t1/2).
Time frame: Baseline to Week 16
To assess immunogenicity: production of anti-drug antibodies (ADA) following SAD and Multiple ascending dose(MAD) doses.
Time frame: Baseline to Week 16