ALX-0061 Phase I Bioavailability Study in Healthy Volunteers

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Biological: ALX-0061

• Registration Number: NCT02101073
• Lead Sponsor: Ablynx, a Sanofi company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-27
• Study First Submitted QC: 2014-03-28
• Study Start: 2014-03-31
• Study First Posted: 2014-04-01
• Primary Completion: 2014-07-31
• Study Completion: 2014-07-31
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-03
• Last Update Posted: 2019-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALX-0061 low dose i.v.	ALX-0061	-
ALX-0061 low dose s.c.	ALX-0061	-
ALX-0061 high dose i.v.	ALX-0061	-
ALX-0061 middle dose s.c.	ALX-0061	-
ALX-0061 high dose s.c.	ALX-0061	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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	* Adverse events and concomitant medication; * Clinical laboratory; * Vital signs; * 12-lead ECG; * Physical examination; * Local reactions