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This is a study to determine the safety of CDX-622 in healthy participants.
CDX-622 is a bispecific antibody that binds to stem cell factor (SCF) and thymic stromal lymphopoietin (TSLP).
This study will evaluate the safety, pharmacokinetics, and Pharmacodynamics of IV single ascending doses (Part 1), IV multiple ascending doses (Part 2), and subcutaneous (SC) single ascending doses (Part 3) of CDX-622 in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CDX-622 | Experimental | Eligible participants will receive doses of CDX-622 by IV or SC |
|
| Normal Saline | Placebo Comparator | Eligible participants will receive doses of Normal Saline by IV or SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDX-622 | Drug | Up to 4 infusions of one of seven dosages of CDX-622 or up to 1 dose by subcutaneous injection of one of three dosages of CDX-622 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety as assessed by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Trials. Infusion reactions will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0. | To evaluate the safety profile as determined by the incidence of adverse events in single or multiple ascending doses of CDX-622 or placebo comparator in healthy participants. | Day 1 up to Day 127 |
| Measure | Description | Time Frame |
|---|---|---|
| CDX-622 serum evaluations over time | CDX-622 serum concentrations will be measured at specified visits | Day 1 up to Day 127 |
| CDX-622 biomarker evaluations over time | The effect of CDX-622 on serum tryptase levels and other relevant biomarkers |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Additional protocol defined inclusion and exclusion criteria could apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion, Inc. | Tempe | Arizona | 85283 | United States |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Normal Saline | Drug | Up to 4 infusions or 6 SC injections of normal saline |
|
| Day 1 up to Day 127 |
| Measurement of anti-drug antibody development over time | Participants will be monitored for the development of anti-drug antibodies | Day 1 up to Day 127 |