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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Unnamed facility
Zuidlaren, Netherlands
Pharmacokinetics: serum concentration of ALX-0061 after single subcutaneous (s.c.) and single intravenous (i.v.) doses of ALX-0061 in healthy volunteers
Time frame: 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
Pharmacodynamics: concentration in plasma of total soluble Interleukin-6 receptor (sIL-6R) and in serum of IL-6
Time frame: 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
Time frame: 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
Time frame: 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
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