Rheumatoid ArthritisPhase 1NCT02101073
ALX-0061 Phase I Bioavailability Study in Healthy Volunteers
A Phase 1 study testing ALX-0061 in people with Rheumatoid Arthritis, run by Ablynx, a Sanofi company at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- ALX-0061
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteNetherlands
- Study dates
- 31 Mar 2014to 31 Jul 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers.
- Gender: male or female.
- Age 18 to 55 years.
- Body mass index (BMI): 18.0 ≥ BMI < 30.0 kg/m2.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- ALX-0061
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALX-0061Biological
single dose, intravenous
ALX-0061Biological
single dose, subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| ALX-0061 low dose i.v. | Experimental | Not described Receives: Biological: ALX-0061 |
| ALX-0061 high dose i.v. | Experimental | Not described Receives: Biological: ALX-0061 |
| ALX-0061 low dose s.c. | Experimental | Not described Receives: Biological: ALX-0061 |
| ALX-0061 middle dose s.c. | Experimental | Not described Receives: Biological: ALX-0061 |
| ALX-0061 high dose s.c. | Experimental | Not described Receives: Biological: ALX-0061 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: serum concentration of ALX-0061 after single subcutaneous (s.c.) and single intravenous (i.v.) doses of ALX-0061 in healthy volunteers
Measured: 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
Measured: 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
- Adverse events and concomitant medication
- Clinical laboratory
- Vital signs
- 12-lead ECG
- Physical examination
- Local reactions
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2014 (estimated)
- Study start31 Mar 2014
- Primary completion31 Jul 2014
- Study completion31 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ablynx, a Sanofi company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven De Bruyn, MD, Study director, Ablynx NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101073
- Sponsor's protocol ID
- ALX0061-C102
- Other IDs
- 2013-005493-21
- Status last verified
- Jan 2019
- First submitted
- 27 Mar 2014
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label Study Evaluating the Bioavailability of ALX-0061 After Subcutaneous and Intravenous Administration in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT02101073
- Acronym / sponsor ID
- ALX0061-C102
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ablynx, a Sanofi companyIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2014 (actual)
- Primary completion
- 31 Jul 2014 (actual)
- Study completion
- 31 Jul 2014 (actual)
- First posted
- 1 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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 (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALX-0061single dose, intravenous | Biological | ALX-0061 high dose i.v., ALX-0061 low dose i.v. |
| ALX-0061single dose, subcutaneous | Biological | ALX-0061 high dose s.c., ALX-0061 low dose s.c., ALX-0061 middle dose s.c. |
Primary outcome
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
3 secondary outcomes
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)
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven De Bruyn, MD study director
Ablynx NV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALX-0061 in people with Rheumatoid Arthritis, run by Ablynx, a Sanofi company at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2019.