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Transient adverse events observed
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| Name | Class |
|---|---|
| Richmond Pharmacology Limited | INDUSTRY |
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The main purpose of this study is to assess the safety and tolerability of SOBI002 in healthy volunteers following single and repeated administration.
This is a double-blind, placebo-controlled, randomized within dose cohort single and repeated dose study with sequential dose escalation.
Eligible volunteers will be divided into dose cohorts and for each cohort, a new panel of 8 volunteers will be randomized to receive either SOBI002 (n=6) or placebo (n=2). SOBI002 will either be administered subcutaneously or intravenously.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOBI002 | Experimental | Single and repeated administration of different doses of test product |
|
| placebo | Placebo Comparator | Single and repeated administration of placebo comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOBI002 | Drug | Test Product |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of SOBI002 in healthy volunteers following single and repeated adminstration | Safety will be evaluated by assessing all Adverse Events, vital signs, 12-lead ECGs, urine samples for determination of urinalysis variables and blood samples for determination of hematology, biochemistry and coagulation variables. | Up to 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of pharmacokinetics of SOBI002 through analysis of serum samples | Up to 13 weeks | |
| Assessment of pharmacodynamics by assessing the inhibition of SOBI002 on hemolytic activity | Up to 13 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erik Brouwer, MD | Swedish Orphan Biovitrum AB (publ) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richmond Pharmacology Ltd. | London | Saint George's University of London | SW17 0RE | United Kingdom |
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| Drug |
Reference product |
|
| Assessment of the immungenicity of SOBI002 by measuring the occurence of anti-drug antibodies | Up to 13 weeks |