HealthyPhase 1NCT01401764
Study Comparing The Tolerability Of Three Excipient Formulations Administered Subcutaneously To Healthy Subjects
A Phase 1 study testing Formulation buffers in people with Healthy, run by Ablynx, a Sanofi company at 1 site in Belgium.
Trial summary
The purpose of the study is to compare local pain experienced after subcutaneous injection of three excipient buffers for delivering protein drugs. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Formulation buffers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- May 2011to Jun 2011
- 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 male or female subjects(no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory.
- Body mass index of 17.5 to 30.5 kg/m2; and a total body weight > 50 kg (110 lbs).
Who cannot join
- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
- Acute disease state (e.g., nausea, vomiting, fever, or diarrhea) within 7 days before study day 1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double Blind, Crossover, Single Centre Study Comparing The Tolerability Of Three Excipient Formulations Administered Subcutaneously To Healthy Subjects
The purpose of the study is to compare local pain experienced after subcutaneous injection of three excipient buffers for delivering protein drugs.
- Conditions
- Healthy
- Being tested
- Formulation buffers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formulation buffersOther
Platform II: Histidine, Polysorbate-80 PASS: Phosphate, Arginine, NaCl ARG 100: Phosphate, 100 mM Arginine
| Study group | Role | What they receive |
|---|---|---|
| Platform II, PASS, ARG 100 | Other | Not described Receives: Other: Formulation buffers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative perception of pain of platform II versus PASS using a likert scale
Measured: 0 minute after injections
Relative perception of pain of platform II versus PASS using a likert scale
Measured: 2 minute after injections
Relative perception of pain of PASS versus Arg 100 using a likert scale
Measured: 0 minute after injections
Relative perception of pain of PASS versus Arg 100 using a likert scale
Measured: 2 minute after injections
Perception of pain of Platform II, PASS and Arg 100 using VAS scale.
Measured: 0 minute after injections
Perception of pain of Platform II, PASS and Arg 100 using VAS scale.
Measured: 2 minute after injections
Perception of burning of Platform II, PASS and Arg 100 using VAS scale.
Measured: 0 minute after injections
Perception of burning of Platform II, PASS and Arg 100 using VAS scale.
Measured: 2 minute after injections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ablynx, a Sanofi company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Josefin-Beate Holz, Study director, Ablynx, a Sanofi company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401764
- Sponsor's protocol ID
- B2271022
- Other IDs
- 2011-000419-15
- Status last verified
- Jan 2013
- First submitted
- 12 Jul 2011
- Last updated
- 31 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Crossover, Single Centre Study Comparing The Tolerability Of Three Excipient Formulations Administered Subcutaneously To Healthy Subjects
- ClinicalTrials.gov ID
- NCT01401764
- Acronym / sponsor ID
- B2271022
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ablynx, a Sanofi companyIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 25 Jul 2011 (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 purpose of the study is to compare local pain experienced after subcutaneous injection of three excipient buffers for delivering protein drugs.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Platform II, PASS, ARG 100 | Other | Other: Formulation buffers |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male or female subjects(no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory.
- Body mass index of 17.5 to 30.5 kg/m2; and a total body weight > 50 kg (110 lbs).
Key exclusion criteria (2 listed)
- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
- Acute disease state (e.g., nausea, vomiting, fever, or diarrhea) within 7 days before study day 1.
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 |
|---|---|---|
| Formulation buffersPlatform II: Histidine, Polysorbate-80 PASS: Phosphate, Arginine, NaCl ARG 100: Phosphate, 100 mM Arginine | Other | Platform II, PASS, ARG 100 |
Primary outcome
Relative perception of pain of platform II versus PASS using a likert scale
Time frame: 0 minute after injections
Relative perception of pain of platform II versus PASS using a likert scale
Time frame: 2 minute after injections
Relative perception of pain of PASS versus Arg 100 using a likert scale
Time frame: 0 minute after injections
Relative perception of pain of PASS versus Arg 100 using a likert scale
Time frame: 2 minute after injections
Perception of pain of Platform II, PASS and Arg 100 using VAS scale.
Time frame: 0 minute after injections
Perception of pain of Platform II, PASS and Arg 100 using VAS scale.
Time frame: 2 minute after injections
Perception of burning of Platform II, PASS and Arg 100 using VAS scale.
Time frame: 0 minute after injections
Perception of burning of Platform II, PASS and Arg 100 using VAS scale.
Time frame: 2 minute after injections
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 31 Jan 2013.
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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.
Josefin-Beate Holz study director
Ablynx, a Sanofi company
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 Formulation buffers in people with Healthy, run by Ablynx, a Sanofi company at 1 site in Belgium.
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 2 inclusion and 2 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 31 Jan 2013. 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 Belgium. 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?
Relative perception of pain of platform II versus PASS using a likert scale (time frame: 0 minute after injections). The study lists 8 primary outcomes in all. 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 31 Jan 2013.