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Completed

NCT Number: NCT02101073

ALX-0061 Phase I Bioavailability Study in Healthy Volunteers

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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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Zuidlaren, 9470, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ALX-0061

Biological

single dose, intravenous

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. Safety and tolerability: safety markers

    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

    • Adverse events and concomitant medication
    • Clinical laboratory
    • Vital signs
    • 12-lead ECG
    • Physical examination
    • Local reactions

  3. 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

Sponsors and collaborators

Lead sponsor

Ablynx, a Sanofi company

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 1, 2014
Registry last updated
Jan 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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