ALX-0061 Phase I Bioavailability Study in Healthy Volunteers

NCT02101073 | Completed Phase 1

• 2 other identifiers: ALX0061-C1022013-005493-21
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis

Outcome Measures

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

  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 (3)

• 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

• 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

Study Arms (5)

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

Interventions

ALX-0061 BIOLOGICAL

single dose, intravenous

ALX-0061 high dose i.v.; ALX-0061 low dose i.v.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ablynx, a Sanofi company: lead

Study Sites (1)

Unknown Facility

Zuidlaren, 9470, Netherlands

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

ALX-0061

Condition Hierarchy (Ancestors)

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

Study Officials

• Steven De Bruyn, MD

  Ablynx NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2014
• First Posted: April 1, 2014
• Study Start: March 31, 2014
• Primary Completion: July 31, 2014
• Study Completion: July 31, 2014
• Last Updated: January 4, 2019

Record last verified: 2019-01

Locations

NL (1)