ALX-0061 Phase I Bioavailability Study in Healthy Volunteers

Study Overview
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Brief Summary
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The overall aims of the study are: To assess the bioavailability of single doses of ALX-0061, administered s.c. at three dose levels, using 2 corresponding single i.v. dose levels as reference. To provide additional information on pharmacokinetics and pharmacodynamics of ALX-0061. To further determine the safety and tolerability of ALX-0061. To further evaluate the systemic (serum) immunogenicity of ALX-0061.

Official Title
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A Phase I, Open-Label Study Evaluating the Bioavailability of ALX-0061 After Subcutaneous and Intravenous Administration in Healthy Volunteers.

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Biological: ALX-0061
* Biological: ALX-0061


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Healthy volunteers. Gender: male or female. Age 18 to 55 years. Body mass index (BMI): 18.0 ≥ BMI < 30.0 kg/m2. Key Exclusion Criteria: Any active inflammatory condition, or autoimmune disorder such as lupus erythematosus, multiple sclerosis or rheumatoid arthritis (RA). Any current or recent (within 4 weeks prior to dose) signs or symptoms of infection that requires parenteral antibiotic administration. Symptomatic infection, or suspicion thereof in the last 1 week prior to dosing.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALX-0061 low dose i.v.<br> | Biological: ALX-0061<br>* single dose, intravenous<br>|
| Experimental: ALX-0061 high dose i.v.<br> | Biological: ALX-0061<br>* single dose, intravenous<br>|
| Experimental: ALX-0061 low dose s.c.<br> | Biological: ALX-0061<br>* single dose, subcutaneous<br>|
| Experimental: ALX-0061 middle dose s.c.<br> | Biological: ALX-0061<br>* single dose, subcutaneous<br>|
| Experimental: ALX-0061 high dose s.c.<br> | Biological: ALX-0061<br>* single dose, subcutaneous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: serum concentration of ALX-0061 after single subcutaneous (s.c.) and single intravenous (i.v.) doses of ALX-0061 in healthy volunteers |  | Day 1 to Day 32 +/- 2 days after dosing for low dose treatment arms, Day 1 to Day 46 +/-2 days after dosing for middle dose treatment arm, Day 1 to Day 53 +/- 2 days after dosing for high dose treatment arms | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamics: concentration in plasma of total soluble Interleukin-6 receptor (sIL-6R) and in serum of IL-6 |  | During screening untill final visit (i.e. 60 +/- 2 days after dosing for the low dose and middle dose treatment arms and 83 +/- 2 days after dosing for the high dose treatment arms) | 
| Safety and tolerability: safety markers | Adverse events and concomitant medication Clinical laboratory Vital signs 12-lead ECG Physical examination Local reactions | From signing of informed consent until final visit (i.e. 60 +/- 2 days for the low dose and middle dose treatment arms and 83 +/- 2 days for the high dose treatment arms | 
| Immunogenicity: concentration of Anti-Drug Antibodies (ADA) in serum |  | From screening until final visit (i.e. 60+/- 2 days after dosing for the low dose and middle dose treatment arms and 83 +/- 2 days after dosing for the high dose treatment arms |