ALX-0061 Phase I Bioavailability Study in Healthy Volunteers

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02101073
• Other study ID #: ALX0061-C102
• Secondary ID: 2013-005493-21
• Status: Completed
• Phase: Phase 1
• Start date: March 31, 2014
• Est. completion date: July 31, 2014

Study information

• Verified date: January 2019
• Source: Ablynx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 31, 2014
• Est. primary completion date: July 31, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• ALX-0061
single dose, intravenous
• ALX-0061
single dose, subcutaneous

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ablynx

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Safety and tolerability: safety markers	Adverse events and concomitant medication; Clinical laboratory; Vital signs; 12-lead ECG; Physical examination; Local reactions	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
Secondary	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