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The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of IBI356 in Healthy Participants and in Atopic Dermatitis Patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI356 for Single ascending dose (SAD) | Experimental |
| |
| IBI356 for Multiple ascending dose (MAD) | Experimental |
| |
| Placebo for MAD | Placebo Comparator |
| |
| Dupilumab for MAD | Active Comparator |
| |
| Placebo for SAD | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI356 for MAD | Drug | Receive IBI356 in a multiple dose. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Adverse Event (AE) in SAD study. | Baseline to Week 20 | |
| Occurrence of Adverse Event (AE) in MAD study. | Baseline to Week 36 | |
| Occurrence of Serious Adverse Event (SAE) in SAD study. | Baseline to Week 20 | |
| Occurrence of Serious Adverse Event (SAE) in MAD study. | Baseline to Week 36 | |
| Changes in blood pressure mmHg (as a measure of safety and tolerability) in SAD study. | Baseline to Week 20 | |
| Changes in blood pressure mmHg (as a measure of safety and tolerability) in MAD study. | Baseline to Week 36 | |
| Changes in respiratory rate measured as breaths per minute (as a measure of safety and tolerability) in SAD study. | Baseline to Week 20 | |
| Changes in respiratory rate measured as breaths per minute (as a measure of safety and tolerability) in MAD study. | Baseline to Week 36 | |
| Changes in heart rate bpm (as a measure of safety and tolerability) in SAD study. | Baseline to Week 20 | |
| Changes in heart rate bpm (as a measure of safety and tolerability) in MAD study. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration time curve from time 0 to last observation (AUC 0-t). | Baseline to Week 16 | |
| Maximum observed concentration (Cmax) after infusion. | Baseline to Week 16 | |
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Inclusion Criteria:
Healthy participants:
Atopic dermatitis:
Exclusion Criteria:
History of relevant drug allergies.
Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
Healthy participants:
Atopic dermatitis:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Skin Disease Hospital | Shanghai | Shanghai Municipality | 200443 | China |
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| Dupilumab for MAD |
| Drug |
Active comparator |
|
| IBI356 for SAD | Drug | Receive IBI356 in a single dose. |
|
| Placebo for SAD | Drug | Receive placebo in a single dose. |
|
| Placebo for MAD | Drug | Receive placebo in a multiple dose. |
|
| Baseline to Week 36 |
| Changes in tympanic temperature °C in SAD study. | Baseline to Week 20 |
| Changes in tympanic temperature °C in MAD study. | Baseline to Week 36 |
| Changes in electrocardiograms PR, QR, QRS and QT intervals (as a measure of safety and tolerability) in SAD study. | Baseline to Week 20 |
| Changes in electrocardiograms PR, QR, QRS and QT intervals (as a measure of safety and tolerability) in MAD study. | Baseline to Week 36 |
| Systemic clearance after infusion (CL). |
| Baseline to Week 16 |
| Volume of distribution during the terminal phase after infusion(Apparent volume of distribution, V). | Baseline to Week 16 |
| Elimination half-life during the terminal phase after infusion(Half-life, t1/2). | Baseline to Week 16 |
| To assess immunogenicity: production of anti-drug antibodies (ADA) following SAD and Multiple ascending dose(MAD) doses. | Baseline to Week 16 |
| ID | Term |
|---|---|
| C110804 | mycophenolic adenine dinucleotide |
| C582203 | dupilumab |
| D064346 | Sagittal Abdominal Diameter |
| ID | Term |
|---|---|
| D049628 | Body Size |
| D001837 | Body Weights and Measures |
| D001824 | Body Constitution |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D000886 | Anthropometry |
| D008919 | Investigative Techniques |
| D010829 | Physiological Phenomena |
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