ALX-0061 Phase I Bioavailability Study in Healthy Volunteers

January 3, 2019 updated by: Ablynx

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ALX-0061 low dose i.v.
Biological: ALX-0061
single dose, intravenous
Biological: ALX-0061
single dose, subcutaneous
Experimental: ALX-0061 high dose i.v.
Biological: ALX-0061
single dose, intravenous
Biological: ALX-0061
single dose, subcutaneous
Experimental: ALX-0061 low dose s.c.
Biological: ALX-0061
single dose, intravenous
Biological: ALX-0061
single dose, subcutaneous
Experimental: ALX-0061 middle dose s.c.
Biological: ALX-0061
single dose, intravenous
Biological: ALX-0061
single dose, subcutaneous
Experimental: ALX-0061 high dose s.c.
Biological: ALX-0061
single dose, intravenous
Biological: ALX-0061
single dose, subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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

Outcome Measure
Measure Description
Time Frame
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)
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
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ablynx

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2014

Primary Completion (Actual)

July 31, 2014

Study Completion (Actual)

July 31, 2014

Study Registration Dates

First Submitted

March 27, 2014

First Submitted That Met QC Criteria

March 28, 2014

First Posted (Estimate)

April 1, 2014

Study Record Updates

Last Update Posted (Actual)

January 4, 2019

Last Update Submitted That Met QC Criteria

January 3, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALX0061-C102
  • 2013-005493-21 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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