Comparing 5 approaches for healthy volunteers
Official title: A Study to Assess the Absolute Bioavailability of Empasiprubart SC Administered With an Autoinjector and the Pharmacokinetic Noninferiority of Empasiprubart SC Versus Intravenous (IV) in Healthy Adult Participants
A Phase 1, Randomized, Open-Label Study to Assess the Absolute Bioavailability of Empasiprubart SC Administered With an Autoinjector (Part A) and the Pharmacokinetic Noninferiority of Empasiprubart SC Versus IV (Part B) in Healthy Adult Participants
- Phase 1
- 5 groups
- One site, in Mount Royal
- Recruiting
Interventions
- Biological therapy
empasiprubart SC AI
Subcutaneous injection of empasiprubart via Autoinjector (AI).
- Biological therapy
empasiprubart IV
Intravenous infusion of empasiprubart
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Altasciences
Mount Royal, Quebec
Eligibility Criteria
See who this study is looking for5 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Is at least the local legal age of consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → and aged 18 to 65 years, inclusive, when signing the ICF.
- +Has a body weight between 50 and 120 kg and a BMI between 18 and 35 kg/m2, inclusive.
Exclusion
- −Has any current or past clinically meaningful medical or psychiatric condition that, in the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s opinion, would confound the study results or put the participant at undue risk.
- −Clinical diagnosis of SLE. For participants with an antinuclear antibody titer of ≥1:80 and a positive anti-double-stranded DNA and/or positive anti-Smith result at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →, an SLE diagnosis must be ruled out before the first IMP administration.
- −Previously participated in an empasiprubart clinical study and received at least 1 dose of IMP.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more → — an early safety study in a small group, checking how it is tolerated and at what dose.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 5 groups in this study.
Groups A and B receive empasiprubart SC AI.
Registry label: A: Open-label treatment period (part A): empasiprubart SC AI (via abdomen) · B: Open-label treatment period (part A): empasiprubart SC AI (via thigh)
Groups C and E receive empasiprubart IV.
Registry label: C: Open-label treatment period (part A): empasiprubart IV · E: Open-label treatment period (part B): empasiprubart IV
Group D receives empasiprubart SC AI, together with one or more of: empasiprubart IV.
Registry label: D: Open-label treatment period (part B): empasiprubart SC AI
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 65 years.
The study is open to people of any sex.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 130 people.
The study is currently expected to finish around October 2027.
The main measurement is taken over: Up to 33 weeks.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
aBA via abdomen as assessed by AUC0-inf SC versus AUC0-inf IV — measured over Up to 33 weeks.
aBA via thigh as assessed by AUC0-inf SC versus AUC0-inf IV — measured over Up to 33 weeks.
Ctrough at week 8 — measured over Up to 8 weeks.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07612020 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About empasiprubart SC AIBiological
Subcutaneous injection of empasiprubart via Autoinjector (AI).
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About empasiprubart IVBiological
Intravenous infusion of empasiprubart
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 65 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 65 years.
It is open to people of any sex.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to 33 weeks.
The study as a whole is currently expected to finish around 2027-10.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 130 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Mount Royal, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
This study aims to see how the body reacts to empasiprubart, administered using an autoinjector (AI). The study will also look at other effects of empasiprubart, how it works in the body, and if it is safe. The study consists of 2 parts: parts A and B. In part A, eligible participants will be randomized to receive empasiprubart SC AI via abdomen, empasiprubart SC AI via thigh, or empasiprubart IV (intravenously). In part B, eligible participants will be randomized to receive empasiprubart SC AI via abdomen or empasiprubart IV. Participants from part A will be in the study for approximately up to 37 weeks . Participants from part B will be in the study for up to approximately 43 weeks.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.