BioequivalencePhase 1NCT05817435
A Phase 1 Bioequivalence Study of Efgartigimod PH20 SC Administered Via a Prefilled Syringe Versus a Vial+Syringe Presentation in Healthy Adults
A Phase 1 study testing efgartigimod PH20 SC as a prefilled syringe presentation and efgartigimod PH20 SC as a vial + syringe presentation in people with Bioequivalence, run by argenx at 2 sites in United States.
Trial summary
This is a randomized, open-label, parallel-group, single-dose study comparing the pharmacokinetics of efgartigimod in blood following a single administration of efgartigimod PH20 SC via a prefilled syringe versus a vial + syringe in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- efgartigimod PH20 SC as a prefilled syringe presentation and efgartigimod PH20 SC as a vial + syringe presentation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Mar 2023to 12 May 2023
- 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 for participation in a clinical study and ≤55 years when signing the ICF
- Is capable of providing signed informed consent, and complying with protocol requirements
- Agrees to use contraceptive measures consistent with local regulations and the following: Women Of Child-Bearing Potential must have a negative serum hCG pregnancy test at screening and a negative urine hCG pregnancy test at baseline before receiving IMP.
- Has a BMI between 18 and 30 kg/m2 , inclusive, and a weight between 50 and 100 kg (inclusive) at screening
Who cannot join
- Has a known autoimmune disease or any medical condition that, in the investigator's judgment, would interfere with an accurate assessment of clinical symptoms or puts the participant at undue risk
- Has a history of malignancy, unless considered cured by adequate treatment with no evidence of recurrence for ≥3 years before the administration of IMP. Adequately-treated participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histological findings of prostate cancer.
- Has a clinically significant active infection that is not sufficiently resolved in the investigator's opinion.
- Has a positive serum test at screening for active infection with any of the following: HBV indicative of an acute or chronic infection, unless associated with a negative HBsAg or negative HBV DNA test; HCV based on HCV antibody assay unless a negative RNA test is available ; HIV based on test results (regardless of therapy treatment or not).
- Has a clinically significant disease, recent major surgery (within 3 months of screening), or intends to have surgery during the study; or any other medical condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk.
- Received a different IMP in another clinical study <12 weeks or 5 half-lives (whichever is longer) before screening.
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- Is currently participating in another interventional clinical study. Has a known hypersensitivity to IMP or its excipients.
- Has abdominal skin condition that does not allow for absorption and assessment of local safety of the planned SC injection, as determined by the investigator.
- Has a history of (within 12 months before screening) or current alcohol, drug, or medication abuse, as assessed by the investigator.
- Is pregnant or lactating or intends to become pregnant during the study.
- Previously participated in an efgartigimod clinical study and received at least 1 dose of IMP.
- Is taking concomitant medications (except for oral contraceptives or occasional acetaminophen).
- Has a total IgG of <4 g/L at screening.
- Had a positive COVID-19 test result on day -1 or contact with someone with a known COVID-19 infection within 2 weeks before receiving IMP.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Investigator site 0010208
Lincoln, Nebraska, 68510
Investigator site 0010209
Tempe, Arizona, 85282
About this study
Official title: A Phase 1, Randomized, Open-label, Parallel-Group, Single-Dose, Bioequivalence Study of Efgartigimod PH20 SC Administered Via a Prefilled Syringe Versus a Vial + Syringe Presentation in Healthy Adults
This is a randomized, open-label, parallel-group, single-dose study comparing the pharmacokinetics of efgartigimod in blood following a single administration of efgartigimod PH20 SC via a prefilled syringe versus a vial + syringe in healthy participants.
- Conditions
- Bioequivalence
- Being tested
- efgartigimod PH20 SC as a prefilled syringe presentation, efgartigimod PH20 SC as a vial + syringe presentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
efgartigimod PH20 SC as a prefilled syringe presentationBiological
efgartigimod PH20 SC as a prefilled syringe presentation
efgartigimod PH20 SC as a vial + syringe presentationBiological
efgartigimod PH20 SC as a vial + syringe presentation
| Study group | Role | What they receive |
|---|---|---|
| Efgartigimod PH20 SC - prefilled syringe | Experimental | efgartigimod PH20 SC administered by a prefilled syringe Receives: Biological: efgartigimod PH20 SC as a prefilled syringe presentation |
| Efgartigimod PH20 SC - vial + syringe | Active comparator | efgartigimod PH20 SC administered by a vial + syringe Receives: Biological: efgartigimod PH20 SC as a vial + syringe presentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary PK parameters (Cmax)
maximum observed plasma concentration
Measured: Up to 29 days
Primary PK parameters (AUC0-inf)
area under the concentration-time curve from 0 to infinity
Measured: Up to 29 days
Secondary outcomes (10)
Total IgG as percent change from baseline over time
Measured: up to 57 days
Total IgG as absolute change from baseline over time
Measured: up to 57 days
Safety parameters (number of AEs)
Measured: up to 85 days
Incidence of ADA against efgartigimod PH20 SC
Incidence of antidrug antibodies against efgartigimod PH20 SC
Measured: up to 57 days
Second PK parameters (Tmax)
time to maximum concentration
Measured: up to 57 days
Second PK parameters (AUC0-t)
area under the concentration-time curve from 0 to last quantifiable concentration
Measured: up to 57 days
Second PK parameters (AUC0-168h)
area under the concentration-time curve from time 0 to168 hours
Measured: up to 57 days
Second PK parameters (t1/2)
elimination half-life
Measured: up to 57 days
Second PK parameters (Vz/F)
apparent volume of distribution
Measured: up to 57 days
Second PK parameters (CL/F)
apparent clearance (total body clearance for extravascular administration divided by the fraction of dose absorbed, calculated using the observed value of the last nonzero concentration)
Measured: up to 57 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start13 Mar 2023
- Primary completion12 May 2023
- Study completion12 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BioequivalenceStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817435
- Sponsor's protocol ID
- ARGX-113-2204
- Status last verified
- Oct 2023
- First submitted
- 5 Apr 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
De Muynck C, Noukens J, Allosery K, Cettour-Rose C, Pastouret S, Andre AD, Borgions F. Investigating the Pharmacokinetics, Injection Speed, and Usability of Subcutaneous Efgartigimod PH20 Administered with a Prefilled Syringe. Adv Ther. 2026 Sep 1. doi: 10.1007/s12325-026-03733-x. Online ahead of print.
PubMed 42678488
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-label, Parallel-Group, Single-Dose, Bioequivalence Study of Efgartigimod PH20 SC Administered Via a Prefilled Syringe Versus a Vial + Syringe Presentation in Healthy Adults
- ClinicalTrials.gov ID
- NCT05817435
- Acronym / sponsor ID
- ARGX-113-2204
- Conditions
- Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 12 May 2023 (actual)
- Study completion
- 12 May 2023 (actual)
- First posted
- 18 Apr 2023 (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 is a randomized, open-label, parallel-group, single-dose study comparing the pharmacokinetics of efgartigimod in blood following a single administration of efgartigimod PH20 SC via a prefilled syringe versus a vial + syringe in healthy participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Efgartigimod PH20 SC - prefilled syringe | Experimental | Biological: efgartigimod PH20 SC as a prefilled syringe presentationefgartigimod PH20 SC administered by a prefilled syringe |
| Efgartigimod PH20 SC - vial + syringe | Active comparator | Biological: efgartigimod PH20 SC as a vial + syringe presentationefgartigimod PH20 SC administered by a vial + syringe |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Is at least the local legal age of consent for participation in a clinical study and ≤55 years when signing the ICF
- Is capable of providing signed informed consent, and complying with protocol requirements
- Agrees to use contraceptive measures consistent with local regulations and the following: Women Of Child-Bearing Potential must have a negative serum hCG pregnancy test at screening and a negative urine hCG pregnancy test at baseline before receiving IMP.
- Has a BMI between 18 and 30 kg/m2 , inclusive, and a weight between 50 and 100 kg (inclusive) at screening
Key exclusion criteria (14 listed)
- Has a known autoimmune disease or any medical condition that, in the investigator's judgment, would interfere with an accurate assessment of clinical symptoms or puts the participant at undue risk
- Has a history of malignancy, unless considered cured by adequate treatment with no evidence of recurrence for ≥3 years before the administration of IMP. Adequately-treated participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histological findings of prostate cancer.
- Has a clinically significant active infection that is not sufficiently resolved in the investigator's opinion.
- Has a positive serum test at screening for active infection with any of the following: HBV indicative of an acute or chronic infection, unless associated with a negative HBsAg or negative HBV DNA test; HCV based on HCV antibody assay unless a negative RNA test is available ; HIV based on test results (regardless of therapy treatment or not).
- Has a clinically significant disease, recent major surgery (within 3 months of screening), or intends to have surgery during the study; or any other medical condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk.
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 as a prefilled syringe presentationefgartigimod PH20 SC as a prefilled syringe presentation | Biological | Efgartigimod PH20 SC - prefilled syringe |
| efgartigimod PH20 SC as a vial + syringe presentationefgartigimod PH20 SC as a vial + syringe presentation | Biological | Efgartigimod PH20 SC - vial + syringe |
Primary outcome
Primary PK parameters (Cmax)
Time frame: Up to 29 days
maximum observed plasma concentration
Primary PK parameters (AUC0-inf)
Time frame: Up to 29 days
area under the concentration-time curve from 0 to infinity
10 secondary outcomes
Total IgG as percent change from baseline over time
Time frame: up to 57 days
Total IgG as absolute change from baseline over time
Time frame: up to 57 days
Safety parameters (number of AEs)
Time frame: up to 85 days
Incidence of ADA against efgartigimod PH20 SC
Time frame: up to 57 days
Second PK parameters (Tmax)
Time frame: up to 57 days
Second PK parameters (AUC0-t)
Time frame: up to 57 days
Second PK parameters (AUC0-168h)
Time frame: up to 57 days
Second PK parameters (t1/2)
Time frame: up to 57 days
Second PK parameters (Vz/F)
Time frame: up to 57 days
Second PK parameters (CL/F)
Time frame: up to 57 days
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 Oct 2023.
- Derived from this study: PubMed 42678488De Muynck C, Noukens J, Allosery K, Cettour-Rose C, Pastouret S, Andre AD, Borgions F. Investigating the Pharmacokinetics, Injection Speed, and Usability of Subcutaneous Efgartigimod PH20 Administered with a Prefilled Syringe. Adv Ther. 2026 Sep 1. doi: 10.1007/s12325-026-03733-x. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 as a prefilled syringe presentation and efgartigimod PH20 SC as a vial + syringe presentation in people with Bioequivalence, run by argenx at 2 sites in United States.
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 14 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 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 parameters (Cmax) (time frame: Up to 29 days). 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?
On the ClinicalTrials.gov record for NCT05817435, which also lists 1 linked publication.
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 Oct 2023.