Healthy VolunteersPhase 1NCT02189733
Bioequivalence of Liquid and Reconstituted Lyophilized Subcutaneous Formulations of Caplacizumab.
A Phase 1 study testing Caplacizumab in people with Healthy Volunteers, run by Ablynx, a Sanofi company at 1 site in United Kingdom.
Trial summary
The primary objective of the study is to evaluate the pharmacokinetic characteristics and demonstrate bioequivalence of a reconstituted new lyophilized formulation of caplacizumab for subcutaneous (s.c.) injection as compared to an equal nominal s.c. dose of the reference liquid formulation of caplacizumab. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Caplacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2014to Sep 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male Caucasians aged 18 to 55 years, inclusive.
- Body weight 55 - 100 kg and body mass index (BMI) between 18.5 and 30.0, extremes included.
- Coagulation and bleeding diathesis variables (as defined in the protocol) within the normal range at screening and on Day -1.
- Others as defined in the protocol.
Who cannot join
- History or presence of diseases in the kidneys and/or heart, lungs, liver, skin, endocrine organs or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- History of and/or any sign or symptom indicating current abnormal hemostasis or blood dyscrasia.
- Others as defined in the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single Center, Open-Label, Randomized, Single Dose Cross-Over Study in Healthy Male Subjects to Investigate the Bioequivalence and Tolerability of Liquid and Reconstituted Lyophilized Subcutaneous Formulations of Caplacizumab.
The primary objective of the study is to evaluate the pharmacokinetic characteristics and demonstrate bioequivalence of a reconstituted new lyophilized formulation of caplacizumab for subcutaneous (s.c.) injection as compared to an equal nominal s.c. dose of the reference liquid formulation of caplacizumab.
The secondary objective of the study is to compare the safety and tolerability, and the pharmacodynamic parameters of the new formulation with those of the reference formulation.
- Conditions
- Healthy Volunteers
- Being tested
- Caplacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaplacizumabBiological
Comparison of reconstituted lyophilised formulation versus liquid formulation of caplacizumab
| Study group | Role | What they receive |
|---|---|---|
| Caplacizumab - Treatment A | Experimental | Single s.c. dose of reconstituted lyophilized solution of caplacizumab followed by single s.c. dose of liquid formulation of caplacizumab Receives: Biological: Caplacizumab |
| Caplacizumab - Treatment B | Experimental | Single s.c. dose of liquid formulation of caplacizumab followed by single s.c. dose of reconstituted lyophilized solution of caplacizumab Receives: Biological: Caplacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: concentration of caplacizumab in plasma
Measured: Day 1 (pre-dose) until Day 7
Secondary outcomes (4)
Pharmacodynamics as measured by Ristocetin cofactor activity in plasma
Measured: During screening until day 29 +/-1
Safety and Tolerability: safety markers
Adverse events, local tolerability, laboratory assessments, urinalysis, vital signs, 12-lead ECG, physical examinations
Measured: From signing of informed consent form until day 43 +/- 2
Pharmacodynamics as measured by von Willebrand factor antigen in plasma
Measured: During screening until Day 29 +/- 1
Pharmacodynamics as measured by Factor VIII clotting activity in plasma
Measured: During screening until day 29 +/- 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ablynx, a Sanofi company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Michel Paillarse, MD, Study director, Ablynx, a Sanofi company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189733
- Sponsor's protocol ID
- ALX0681-C102
- Other IDs
- 2014-001294-13, 2014
- Status last verified
- Jul 2014
- First submitted
- 10 Jul 2014
- Last updated
- 14 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single Center, Open-Label, Randomized, Single Dose Cross-Over Study in Healthy Male Subjects to Investigate the Bioequivalence and Tolerability of Liquid and Reconstituted Lyophilized Subcutaneous Formulations of Caplacizumab.
- ClinicalTrials.gov ID
- NCT02189733
- Acronym / sponsor ID
- ALX0681-C102
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ablynx, a Sanofi companyIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Sep 2014 (actual)
- First posted
- 15 Jul 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 primary objective of the study is to evaluate the pharmacokinetic characteristics and demonstrate bioequivalence of a reconstituted new lyophilized formulation of caplacizumab for subcutaneous (s.c.) injection as compared to an equal nominal s.c. dose of the reference liquid formulation of caplacizumab.
The secondary objective of the study is to compare the safety and tolerability, and the pharmacodynamic parameters of the new formulation with those of the reference formulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caplacizumab - Treatment A | Experimental | Biological: CaplacizumabSingle s.c. dose of reconstituted lyophilized solution of caplacizumab followed by single s.c. dose of liquid formulation of caplacizumab |
| Caplacizumab - Treatment B | Experimental | Biological: CaplacizumabSingle s.c. dose of liquid formulation of caplacizumab followed by single s.c. dose of reconstituted lyophilized solution of caplacizumab |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male Caucasians aged 18 to 55 years, inclusive.
- Body weight 55 - 100 kg and body mass index (BMI) between 18.5 and 30.0, extremes included.
- Coagulation and bleeding diathesis variables (as defined in the protocol) within the normal range at screening and on Day -1.
- Others as defined in the protocol.
Key exclusion criteria (3 listed)
- History or presence of diseases in the kidneys and/or heart, lungs, liver, skin, endocrine organs or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- History of and/or any sign or symptom indicating current abnormal hemostasis or blood dyscrasia.
- Others as defined in the protocol
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 |
|---|---|---|
| CaplacizumabComparison of reconstituted lyophilised formulation versus liquid formulation of caplacizumab | Biological | Caplacizumab - Treatment A, Caplacizumab - Treatment B |
Primary outcome
Pharmacokinetics: concentration of caplacizumab in plasma
Time frame: Day 1 (pre-dose) until Day 7
4 secondary outcomes
Pharmacodynamics as measured by Ristocetin cofactor activity in plasma
Time frame: During screening until day 29 +/-1
Safety and Tolerability: safety markers
Time frame: From signing of informed consent form until day 43 +/- 2
Pharmacodynamics as measured by von Willebrand factor antigen in plasma
Time frame: During screening until Day 29 +/- 1
Pharmacodynamics as measured by Factor VIII clotting activity in plasma
Time frame: During screening until day 29 +/- 1
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 14 Nov 2014.
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Screening Protocol
Pain
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.
Jean-Michel Paillarse, MD 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 Caplacizumab in people with Healthy Volunteers, run by Ablynx, a Sanofi company at 1 site in United Kingdom.
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 14 Nov 2014. 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 United Kingdom. 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: concentration of caplacizumab in plasma (time frame: Day 1 (pre-dose) until Day 7). 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 14 Nov 2014.