ALX-0061 Phase I Bioavailability Study in Healthy Volunteers

NCT02101073 — Phase 1, Completed, 70 participants, Ablynx, a Sanofi company

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

Registry	NCT02101073
Status	Completed
Phase	Phase 1
Study type	Interventional; non randomized, parallel, masking: none, treatment
Enrollment	70 (Actual)
Sponsor	Ablynx, a Sanofi company (Industry)
Conditions	Rheumatoid Arthritis
Interventions	ALX-0061 (Biological)
Dates	start 2014-03-31, primary completion 2014-07-31, completion 2014-07-31, first posted 2014-04-01, last updated 2019-01-04
Locations	1 site in Netherlands

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions
ALX-0061 low dose i.v.	Experimental	Biological: ALX-0061
ALX-0061 high dose i.v.	Experimental	Biological: ALX-0061
ALX-0061 low dose s.c.	Experimental	Biological: ALX-0061
ALX-0061 middle dose s.c.	Experimental	Biological: ALX-0061
ALX-0061 high dose s.c.	Experimental	Biological: ALX-0061

ALX-0061 (Biological): single dose, intravenous
ALX-0061 (Biological): single dose, subcutaneous

+Outcome measures

Primary outcomes

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 outcomes

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 [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]: * Adverse events and concomitant medication * Clinical laboratory * Vital signs * 12-lead ECG * Physical examination * Local reactions
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]

+Eligibility

Sex: All, ages: 18 Years to 55 Years, accepts healthy volunteers

Key Inclusion Criteria:

1. Healthy volunteers.
2. Gender: male or female.
3. Age 18 to 55 years.
4. Body mass index (BMI): 18.0 ≥ BMI < 30.0 kg/m2.

Key Exclusion Criteria:

1. Any active inflammatory condition, or autoimmune disorder such as lupus erythematosus, multiple sclerosis or rheumatoid arthritis (RA).
2. Any current or recent (within 4 weeks prior to dose) signs or symptoms of infection that requires parenteral antibiotic administration.
3. Symptomatic infection, or suspicion thereof in the last 1 week prior to dosing.

+Locations (1)

Facility	City	Country	Status
	Zuidlaren	Netherlands

+Investigators

Steven De Bruyn, MD, Study director, Ablynx NV