A study investigating the biological availability of ALX-0061, a new drug in the treatment of rheumatoid arthritis, after subcutaneous and intravenous administration in healthy volunteers.

A study investigating the biological availability of ALX-0061, a new drug in the treatment of rheumatoid arthritis, after subcutaneous and intravenous administration in healthy volunteers. - ALX-0061 phase I bioavailability study in healthy volunteers.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40925

Enrollment

Registered

2014-03-13

Start date

2014-03-31

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic systemic inflammatory disease rheumatoid arthritis

Interventions

The volunteers will receive a single dose of ALX-0061 according to one of the 5 treatment groups below: Group Day Route of administration Treatment 1 1 intravenously 50 mg ALX-0061 2 1 subcutaneous

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male or female volunteers Age between 18 and 55 years BMI between 18.0 - 30.0 kg/m2

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
Primary objective: To assess the pharmacokinetics of single subcutaneous (s.c.) and intravenous (i.v.) doses of ALX-0061 in healthy volunteers.	—

Secondary

Measure	Time frame
Secondary objective: To assess the pharmacodynamics, safety, tolerability, and immunogenicity of single s.c. and i.v. doses of ALX-0061 in healthy volunteers.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)