Healthy VolunteersPhase 1NCT07612020
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 study testing empasiprubart SC AI and empasiprubart IV in people with Healthy Volunteers, run by argenx at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- empasiprubart SC AI and empasiprubart IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteCanada
- Study dates
- 16 Mar 2026to Oct 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Is at least the local legal age of consent 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.
Who cannot join
- Has any current or past clinically meaningful medical or psychiatric condition that, in the investigator'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 screening, 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Altasciences
Mount Royal, Quebec, H3P 3P1
Gaetano Morelli, MD, +1 857-350-4834, clinicaltrials@argenx.com
About this study
Official title: 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
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.
- Conditions
- Healthy Volunteers
- Being tested
- empasiprubart SC AI, empasiprubart IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
empasiprubart SC AIBiological
Subcutaneous injection of empasiprubart via Autoinjector (AI).
empasiprubart IVBiological
Intravenous infusion of empasiprubart
| Study group | Role | What they receive |
|---|---|---|
| Open-label treatment period (part A): empasiprubart SC AI (via abdomen) | Experimental | Participants randomized to receive empasiprubart SC AI via abdomen. Receives: Biological: empasiprubart SC AI |
| Open-label treatment period (part A): empasiprubart SC AI (via thigh) | Experimental | Participants randomized to receive empasiprubart SC AI via thigh. Receives: Biological: empasiprubart SC AI |
| Open-label treatment period (part A): empasiprubart IV | Experimental | Participants randomized to receive empasiprubart IV. Receives: Biological: empasiprubart IV |
| Open-label treatment period (part B): empasiprubart SC AI | Experimental | Participants randomized to receive empasiprubart IV and empasiprubart SC AI. Receives: Biological: empasiprubart SC AI; Biological: empasiprubart IV |
| Open-label treatment period (part B): empasiprubart IV | Experimental | Participants randomized to receive empasiprubart IV. Receives: Biological: empasiprubart IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
aBA via abdomen as assessed by AUC0-inf SC versus AUC0-inf IV
aBA = absolute bioavailability; AUC0-inf=area under the concentration-time curve from time 0 to infinity; PK = pharmacokinetics; SC = subcutaneous, IV = intravenous
Measured: Up to 33 weeks
aBA via thigh as assessed by AUC0-inf SC versus AUC0-inf IV
aBA = absolute bioavailability; AUC0-inf=area under the concentration-time curve from time 0 to infinity; PK = pharmacokinetics; SC = subcutaneous, IV = intravenous
Measured: Up to 33 weeks
Ctrough at week 8
Ctrough = trough concentration
Measured: Up to 8 weeks
Secondary outcomes (7)
empasiprubart Cmax
Cmax = maximum observed concentration
Measured: Up to 33 weeks
AUCw4-8 over time
AUCw4-8 = area under the concentration-time curve from week 4 to week 8
Measured: Up to 39 weeks
Cavg over time
Cavg = average concentration
Measured: Up to 39 weeks
Ctrough over time
Ctrough = trough concentration
Measured: Up to 39 weeks
Percentage change from baseline in free C2 and total C2 over time
C2 = complement component 2
Measured: Up to 33 weeks (Part A) + up to 39 weeks (Part B)
Incidence of ADA against empasiprubart in serum
ADA = antidrug antibody(ies)
Measured: Up to 33 weeks (Part A) + up to 39 weeks (Part B)
Incidence of AEs, SAEs, and AEs leading to empasiprubart discontinuation
AE=adverse event; SAE=serious adverse event
Measured: Up to 33 weeks (Part A) + up to 39 weeks (Part B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start16 Mar 2026
- Primary completionMar 2027 (estimated)
- Study completionOct 2027 (estimated)
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.
- More trials run by argenxThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612020
- Sponsor's protocol ID
- ARGX-117-900-XIND-1003
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07612020
- Acronym / sponsor ID
- ARGX-117-900-XIND-1003
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 28 May 2026 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Open-label treatment period (part A): empasiprubart SC AI (via abdomen) | Experimental | Biological: empasiprubart SC AIParticipants randomized to receive empasiprubart SC AI via abdomen. |
| Open-label treatment period (part A): empasiprubart SC AI (via thigh) | Experimental | Biological: empasiprubart SC AIParticipants randomized to receive empasiprubart SC AI via thigh. |
| Open-label treatment period (part A): empasiprubart IV | Experimental | Biological: empasiprubart IVParticipants randomized to receive empasiprubart IV. |
| Open-label treatment period (part B): empasiprubart SC AI | Experimental | Biological: empasiprubart SC AI, Biological: empasiprubart IVParticipants randomized to receive empasiprubart IV and empasiprubart SC AI. |
| Open-label treatment period (part B): empasiprubart IV | Experimental | Biological: empasiprubart IVParticipants randomized to receive empasiprubart IV. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Is at least the local legal age of consent 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.
Key exclusion criteria (3 listed)
- Has any current or past clinically meaningful medical or psychiatric condition that, in the investigator'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 screening, 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.
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 |
|---|---|---|
| empasiprubart SC AISubcutaneous injection of empasiprubart via Autoinjector (AI). | Biological | Open-label treatment period (part A): empasiprubart SC AI (via abdomen), Open-label treatment period (part A): empasiprubart SC AI (via thigh), Open-label treatment period (part B): empasiprubart SC AI |
| empasiprubart IVIntravenous infusion of empasiprubart | Biological | Open-label treatment period (part A): empasiprubart IV, Open-label treatment period (part B): empasiprubart IV, Open-label treatment period (part B): empasiprubart SC AI |
Primary outcome
aBA via abdomen as assessed by AUC0-inf SC versus AUC0-inf IV
Time frame: Up to 33 weeks
aBA = absolute bioavailability; AUC0-inf=area under the concentration-time curve from time 0 to infinity; PK = pharmacokinetics; SC = subcutaneous, IV = intravenous
aBA via thigh as assessed by AUC0-inf SC versus AUC0-inf IV
Time frame: Up to 33 weeks
aBA = absolute bioavailability; AUC0-inf=area under the concentration-time curve from time 0 to infinity; PK = pharmacokinetics; SC = subcutaneous, IV = intravenous
Ctrough at week 8
Time frame: Up to 8 weeks
Ctrough = trough concentration
7 secondary outcomes
empasiprubart Cmax
Time frame: Up to 33 weeks
AUCw4-8 over time
Time frame: Up to 39 weeks
Cavg over time
Time frame: Up to 39 weeks
Ctrough over time
Time frame: Up to 39 weeks
Percentage change from baseline in free C2 and total C2 over time
Time frame: Up to 33 weeks (Part A) + up to 39 weeks (Part B)
Incidence of ADA against empasiprubart in serum
Time frame: Up to 33 weeks (Part A) + up to 39 weeks (Part B)
Incidence of AEs, SAEs, and AEs leading to empasiprubart discontinuation
Time frame: Up to 33 weeks (Part A) + up to 39 weeks (Part B)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
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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.
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 empasiprubart SC AI and empasiprubart IV in people with Healthy Volunteers, run by argenx at 1 site in Canada.
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 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: looking for participants now, as of the sponsor's last update on 28 May 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabine Coppieters, MD (857-350-4834, clinicaltrials@argenx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
aBA via abdomen as assessed by AUC0-inf SC versus AUC0-inf IV (time frame: Up to 33 weeks). The study lists 3 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 28 May 2026.