Healthy VolunteerPhase 1NCT07782775
A Study to Assess the Bioequivalence of Efgartigimod PH20 SC Between Autoinjector and Prefilled Syringe in Healthy Adult Participants
A Phase 1 study testing Efgartigimod PH20 SC via PFS and Efgartigimod PH20 SC via AI in people with Healthy Volunteer and Healthy Adult Participants, run by argenx at 1 site in Canada.
Trial summary
The aim of this study is to compare the amount of efgartigimod in the blood over time after it is injected via Prefilled syringe (PFS) and Autoinjector (AI). The study will comprise 2 study periods of 3 weeks each. Each participant receives both efgartigimod PH20 SC AI and PFS treatments, in a different order. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, Healthy Adult Participants
- What is being tested?
- Efgartigimod PH20 SC via PFS and Efgartigimod PH20 SC via AI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- 19 Jun 2026to 23 Sep 2026
- 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
- Is at least the local legal age of consent and aged 18 to 55 years, inclusive, when signing the ICF.
- Has a body weight between 50 and 100 kg and a BMI between 18 and 30 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.
- Has received any medications, including nonprescription and prescription medications, within 2 weeks before the first IMP administration, except for hormonal contraceptives and hormone replacement therapy in female participants. The occasional use of acetaminophen or ibuprofen is allowed.
- Previously participated in an efgartigimod clinical study and received at least 1 dose of IMP.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Randomized, Single-Dose, 2-Period Crossover, Bioequivalence Study of Efgartigimod PH20 SC Administered Via Autoinjector Versus Prefilled Syringe in Healthy Adult Participants
The aim of this study is to compare the amount of efgartigimod in the blood over time after it is injected via Prefilled syringe (PFS) and Autoinjector (AI).
The study will comprise 2 study periods of 3 weeks each. Each participant receives both efgartigimod PH20 SC AI and PFS treatments, in a different order.
Participants will be in the study for up to approximately 9 weeks.
- Conditions
- Healthy Volunteer, Healthy Adult Participants
- Being tested
- Efgartigimod PH20 SC via PFS, Efgartigimod PH20 SC via AI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efgartigimod PH20 SC via PFSBiological
Subcutaneous injection of empasiprubart via Prefilled syringe (PFS)
Efgartigimod PH20 SC via AIBiological
Subcutaneous injection of empasiprubart via Autoinjector (AI)
| Study group | Role | What they receive |
|---|---|---|
| Treatment sequence 1 | Experimental | Participants randomized to receive Efgartigimod PH20 SC via AI in period 1 and Efgartigimod PH20 SC via PFS in period 2 Receives: Biological: Efgartigimod PH20 SC via PFS; Biological: Efgartigimod PH20 SC via AI |
| Treatment sequence 2 | Experimental | Participants randomized to receive Efgartigimod PH20 SC via PFS in period 1 and Efgartigimod PH20 SC via AI in period 2 Receives: Biological: Efgartigimod PH20 SC via PFS; Biological: Efgartigimod PH20 SC via AI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary PK parameter: Cmax
Cmax = maximum observed concentration
Measured: Up to 9 weeks
Primary PK parameter: AUC0-inf
AUC0-inf = area under the curve from time 0 to infinity
Measured: Up to 9 weeks
Secondary outcomes (7)
Secondary PK parameter: AUC0-t
AUC0-t = area under the curve from time 0 to the last measurable time point
Measured: Up to 9 weeks
Secondary PK parameter: AUC0-168h
AUC0-168h = area under the curve from time 0 to 168 hours
Measured: Up to 9 weeks
Secondary PK parameter: CL/F
CL/F = apparent clearance from plasma after extravascular administration
Measured: Up to 9 weeks
Secondary PK parameter: Vz/F
Vz/F = apparent volume of distribution at steady state after extravascular administration
Measured: Up to 9 weeks
Secondary PK parameter: Tmax
Tmax = time to Cmax
Measured: Up to 9 weeks
Secondary PK parameter: t½
t½ = half-life
Measured: Up to 9 weeks
Incidence of AEs, SAEs, and AEs leading to efgartigimod discontinuation
AE = adverse event ; SAE = serious adverse event
Measured: Up to 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start19 Jun 2026
- Primary completion23 Sep 2026
- Study completion23 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07782775
- Sponsor's protocol ID
- ARGX-113-1-HV-1001
- Status last verified
- Oct 2026
- First submitted
- 20 Aug 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Randomized, Single-Dose, 2-Period Crossover, Bioequivalence Study of Efgartigimod PH20 SC Administered Via Autoinjector Versus Prefilled Syringe in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07782775
- Acronym / sponsor ID
- ARGX-113-1-HV-1001
- Conditions
- Healthy Volunteer, Healthy Adult Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2026 (actual)
- Primary completion
- 23 Sep 2026 (actual)
- Study completion
- 23 Sep 2026 (actual)
- First posted
- 24 Aug 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.
The aim of this study is to compare the amount of efgartigimod in the blood over time after it is injected via Prefilled syringe (PFS) and Autoinjector (AI).
The study will comprise 2 study periods of 3 weeks each. Each participant receives both efgartigimod PH20 SC AI and PFS treatments, in a different order.
Participants will be in the study for up to approximately 9 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment sequence 1 | Experimental | Biological: Efgartigimod PH20 SC via PFS, Biological: Efgartigimod PH20 SC via AIParticipants randomized to receive Efgartigimod PH20 SC via AI in period 1 and Efgartigimod PH20 SC via PFS in period 2 |
| Treatment sequence 2 | Experimental | Biological: Efgartigimod PH20 SC via PFS, Biological: Efgartigimod PH20 SC via AIParticipants randomized to receive Efgartigimod PH20 SC via PFS in period 1 and Efgartigimod PH20 SC via AI in period 2 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Is at least the local legal age of consent and aged 18 to 55 years, inclusive, when signing the ICF.
- Has a body weight between 50 and 100 kg and a BMI between 18 and 30 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.
- Has received any medications, including nonprescription and prescription medications, within 2 weeks before the first IMP administration, except for hormonal contraceptives and hormone replacement therapy in female participants. The occasional use of acetaminophen or ibuprofen is allowed.
- Previously participated in an efgartigimod 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 |
|---|---|---|
| Efgartigimod PH20 SC via PFSSubcutaneous injection of empasiprubart via Prefilled syringe (PFS) | Biological | Treatment sequence 1, Treatment sequence 2 |
| Efgartigimod PH20 SC via AISubcutaneous injection of empasiprubart via Autoinjector (AI) | Biological | Treatment sequence 1, Treatment sequence 2 |
Primary outcome
Primary PK parameter: Cmax
Time frame: Up to 9 weeks
Cmax = maximum observed concentration
Primary PK parameter: AUC0-inf
Time frame: Up to 9 weeks
AUC0-inf = area under the curve from time 0 to infinity
7 secondary outcomes
Secondary PK parameter: AUC0-t
Time frame: Up to 9 weeks
Secondary PK parameter: AUC0-168h
Time frame: Up to 9 weeks
Secondary PK parameter: CL/F
Time frame: Up to 9 weeks
Secondary PK parameter: Vz/F
Time frame: Up to 9 weeks
Secondary PK parameter: Tmax
Time frame: Up to 9 weeks
Secondary PK parameter: t½
Time frame: Up to 9 weeks
Incidence of AEs, SAEs, and AEs leading to efgartigimod discontinuation
Time frame: Up to 9 weeks
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 Oct 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Efgartigimod PH20 SC via PFS and Efgartigimod PH20 SC via AI in people with Healthy Volunteer and Healthy Adult Participants, 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: finished, as of the sponsor's last update on 14 Oct 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?
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?
Primary PK parameter: Cmax (time frame: Up to 9 weeks). The study lists 2 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 14 Oct 2026.