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ALX-0061 Phase I Bioavailability Study in Healthy Volunteers

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 1

Locations

Netherlands

Study Type

Interventional

Intervention

ALX-0061

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

ALX-0061 low dose i.v.

ALX-0061 high dose i.v.

ALX-0061 low dose s.c.

ALX-0061 middle dose s.c.

ALX-0061 high dose s.c.

Arm Description

Outcomes

Primary Outcome Measures

Pharmacokinetics: serum concentration of ALX-0061 after single subcutaneous (s.c.) and single intravenous (i.v.) doses of ALX-0061 in healthy volunteers

Secondary Outcome Measures

Pharmacodynamics: concentration in plasma of total soluble Interleukin-6 receptor (sIL-6R) and in serum of IL-6

Safety and tolerability: safety markers

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

Immunogenicity: concentration of Anti-Drug Antibodies (ADA) in serum

Full Information

NCT ID

NCT02101073

First Posted

March 27, 2014

Last Updated

January 3, 2019

Sponsor

Ablynx, a Sanofi company

1. Study Identification

Unique Protocol Identification Number

NCT02101073

Brief Title

ALX-0061 Phase I Bioavailability Study in Healthy Volunteers

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

March 31, 2014 (Actual)

Primary Completion Date

July 31, 2014 (Actual)

Study Completion Date

July 31, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ablynx, a Sanofi company

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ALX-0061 low dose i.v.

Arm Type

Experimental

Arm Title

ALX-0061 high dose i.v.

Arm Type

Experimental

Arm Title

ALX-0061 low dose s.c.

Arm Type

Experimental

Arm Title

ALX-0061 middle dose s.c.

Arm Type

Experimental

Arm Title

ALX-0061 high dose s.c.

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

ALX-0061

Intervention Description

single dose, intravenous

Intervention Type

Biological

Intervention Name(s)

ALX-0061

Intervention Description

single dose, subcutaneous

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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)

Title

Safety and tolerability: safety markers

Description

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

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven De Bruyn, MD

Organizational Affiliation

Ablynx NV

Official's Role

Study Director

Facility Information:

City

Zuidlaren

ZIP/Postal Code

9470

Country

Netherlands

12. IPD Sharing Statement

Learn more about this trial

ALX-0061 Phase I Bioavailability Study in Healthy Volunteers

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