A Phase 1 Bioequivalence Study of Efgartigimod PH20 SC Administered Via a Prefilled Syringe Versus a Vial+Syringe Presentation in Healthy Adults
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Efgartigimod PH20 SC - prefilled syringe efgartigimod PH20 SC administered by a prefilled syringe |
Biological: efgartigimod PH20 SC as a prefilled syringe presentation
efgartigimod PH20 SC as a prefilled syringe presentation
|
| Active Comparator: Efgartigimod PH20 SC - vial + syringe efgartigimod PH20 SC administered by a vial + syringe |
Biological: efgartigimod PH20 SC as a vial + syringe presentation
efgartigimod PH20 SC as a vial + syringe presentation
|
Outcome Measures
Primary Outcome Measures
- Primary PK parameters (Cmax) [Up to 29 days]
maximum observed plasma concentration
- Primary PK parameters (AUC0-inf) [Up to 29 days]
area under the concentration-time curve from 0 to infinity
Secondary Outcome Measures
- Total IgG as percent change from baseline over time [up to 57 days]
- Total IgG as absolute change from baseline over time [up to 57 days]
- Safety parameters (number of AEs) [up to 85 days]
- Incidence of ADA against efgartigimod PH20 SC [up to 57 days]
Incidence of antidrug antibodies against efgartigimod PH20 SC
- Second PK parameters (Tmax) [up to 57 days]
time to maximum concentration
- Second PK parameters (AUC0-t) [up to 57 days]
area under the concentration-time curve from 0 to last quantifiable concentration
- Second PK parameters (AUC0-168h) [up to 57 days]
area under the concentration-time curve from time 0 to168 hours
- Second PK parameters (t1/2) [up to 57 days]
elimination half-life
- Second PK parameters (Vz/F) [up to 57 days]
apparent volume of distribution
- Second PK parameters (CL/F) [up to 57 days]
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)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Is at least the local legal age of consent for participation in a clinical study and ≤55 years when signing the ICF
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Is capable of providing signed informed consent, and complying with protocol requirements
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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.
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Has a BMI between 18 and 30 kg/m2 , inclusive, and a weight between 50 and 100 kg (inclusive) at screening
Exclusion Criteria:
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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
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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.
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Has a clinically significant active infection that is not sufficiently resolved in the investigator's opinion.
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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).
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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.
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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.
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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.
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Has a history of (within 12 months before screening) or current alcohol, drug, or medication abuse, as assessed by the investigator.
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Is pregnant or lactating or intends to become pregnant during the study.
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Previously participated in an efgartigimod clinical study and received at least 1 dose of IMP.
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Is taking concomitant medications (except for oral contraceptives or occasional acetaminophen).
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Has a total IgG of <4 g/L at screening.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Investigator site 0010209 | Tempe | Arizona | United States | 85282 |
| 2 | Investigator site 0010208 | Lincoln | Nebraska | United States | 68510 |
Sponsors and Collaborators
- argenx
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ARGX-113-2204