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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000534-65 | EudraCT Number |
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The purpose of this study is to evaluate the safety and pharmacodynamics of SELA-070. Increasing subcutaneous doses of SELA-070 will be administered to healthy smoker volunteers. The resulting safety profile and anti-nicotine antibody levels will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SELA-070 | Experimental |
| |
| Saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SELA-070 | Biological | Sub-cutaneous injection, multiple dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of multiple subcutaneous injections of SELA-070 as assessed by frequency of vaccine related adverse events, graded by severity | 21 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of SELA-070 by measuring anti-nicotine antibody titers by Enzyme-Linked Immunosorbent Assay (ELISA). | 21 weeks |
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Primary Inclusion Criteria:
Primary Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Lucardie, MD | SGS LSS Clinical Pharmacology Unit - Antwerpen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS LSS Clinical Pharmacology Unit | Antwerp | Belgium |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Saline |
| Biological |
Sub-cutaneous injection, multiple dose |
|
| D017670 |
| Sodium Compounds |