Safety and Tolerability of SOBI002 in Healthy Volunteers Following Single and Repeated Administration

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SOBI002 Following Subcutaneous and Intravenous Administration. A Double-blind, Placebo-controlled, Randomized Within Dose Cohort, Single and Repeated Dose-escalation Study in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: SOBI002
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females of non-childbearing potential or males 18 to 45 years of age Judged by the Principal Investigator to be healthy on the basis of medical history and a pre-study physical examination including 12-lead electrocardiogram (ECG), 24-hour Holter ECG, vital signs and blood and urine laboratory assessments. Exclusion Criteria: Females of childbearing potential Clinically significant disease Clinically significant abnormal laboratory, ECG, vital signs or other safety findings as determined by medical history, physical examination or other evaluations conducted at screening or on admission.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SOBI002<br>Single and repeated administration of different doses of test product | Drug: SOBI002<br>* Test Product<br>|
| Placebo Comparator: placebo<br>Single and repeated administration of placebo comparator | Drug: Placebo<br>* Reference product<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Assessment of the immungenicity of SOBI002 by measuring the occurence of anti-drug antibodies |  | Up to 13 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase I, Dose cohorts, Escalating dose, Single dose, Multiple dose, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, volunteers