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This is a the first in human study to evaluate the safety, tolerability, PK and PD of single subcutaneous or intravenous dose of IBI112 in healthy subjects
In this first in human, phase 1, randomized, double-blind, placebo-controlled study, a single subcutaneous or intravenous dose of IBI112 will be administered to 46 healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | IBI112 SC dose1 |
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| Cohort 2 | Experimental | IBI112 SC dose2 |
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| Cohort 3 | Experimental | IBI112 SC dose3 |
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| Cohort 4 | Experimental | IBI112 IV dose4 |
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| Cohort 5 | Experimental | IBI112 IV dose3 |
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| Cohort 6 | Experimental | IBI112 SC dose5 |
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| Cohort 7 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI112 dose1 | Drug | Drug: IBI112 SC dose1 Drug:placebo |
| |
| IBI112 dose2 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events in healthy volunteers with single ascending doses of IBI112 | Day1 to Day 113 post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Concentration (Cmax) - Pharmacokinetic Assessment | IV dose & SC dose | Day 113 |
| Time to Maximum Concentration (Tmax) - Pharmacokinetic Assessment | SC dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital Affiliated to Fudan University | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37358916 | Derived | He J, Du W, Yang H, Wang J, Cai C, Ma Q, Li N, Yu J, Wu X, Wu J, Chen Y, Cao G, Zhang J. Safety and pharmacokinetics of IBI112, an IL-23 monoclonal antibody, in Chinese healthy volunteers: a first-in-human phase 1 study. Expert Opin Investig Drugs. 2023 Jul-Dec;32(7):669-675. doi: 10.1080/13543784.2023.2230122. Epub 2023 Jun 29. |
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IBI112 IV dose5 |
|
| Drug |
Drug: IBI112 SC dose2 Drug:placebo |
|
| IBI112 dose3 | Drug | Drug: IBI112 SC dose3 Drug:placebo |
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| IBI112 dose4 | Drug | Drug: IBI112 SC dose4 Drug:placebo |
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| IBI112 dose5 | Drug | Drug: IBI112 IV dose5 Drug:placebo |
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| IBI112 dose6 | Drug | Drug: IBI112 SC dose6 Drug:placebo |
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| IBI112 dose7 | Drug | Drug: IBI112 IV dose7 Drug:placebo |
|
| Day 113 |
| Area Under the Curve Extrapolated to Infinity (AUC0-∞) - Pharmacokinetic Assessment | IV dose & SC dose | Day 113 |
| Half-Life (t1/2) - Pharmacokinetic Assessment | IV dose & SC dose | Day 113 |
| Volume of Distribution (Vd) - Pharmacokinetic Assessment | IV dose & SC dose | Day 113 |