ALX-0061 Phase I Bioavailability Study in Healthy Volunteers

Ablynx

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Biological: ALX-0061

Study type: Interventional

Funder types: Industry

Identifiers

NCT02101073

2013-005493-21 (EudraCT Number)

ALX0061-C102

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 5 patient groups

ALX-0061 low dose i.v.

Experimental group

Treatment:

Biological: ALX-0061

Biological: ALX-0061

ALX-0061 high dose i.v.

Experimental group

Treatment:

Biological: ALX-0061

Biological: ALX-0061

ALX-0061 low dose s.c.

Experimental group

Treatment:

Biological: ALX-0061

Biological: ALX-0061

ALX-0061 middle dose s.c.

Experimental group

Treatment:

Biological: ALX-0061

Biological: ALX-0061

ALX-0061 high dose s.c.

Experimental group

Treatment:

Biological: ALX-0061

Biological: ALX-0061