Clinical trial NCT05817435: A Phase 1 Bioequivalence Study of Efgartigimod PH20 SC Administered Via a Prefilled Syringe Versus a Vial+Syringe Presentation in Healthy Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioequivalence
Lead sponsor: argenx
Sponsor class: INDUSTRY
First posted: 2023-04-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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
* 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

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Primary PK parameters (Cmax)
timeFrame: Up to 29 days
measure: Primary PK parameters (AUC0-inf)
timeFrame: Up to 29 days
Secondary outcomes:
measure: Total IgG as percent change from baseline over time
timeFrame: up to 57 days
measure: Total IgG as absolute change from baseline over time
timeFrame: up to 57 days
measure: Safety parameters (number of AEs)
timeFrame: up to 85 days
measure: Incidence of ADA against efgartigimod PH20 SC
timeFrame: up to 57 days
measure: Second PK parameters (Tmax)
timeFrame: up to 57 days
measure: Second PK parameters (AUC0-t)
timeFrame: up to 57 days
measure: Second PK parameters (AUC0-168h)
timeFrame: up to 57 days
measure: Second PK parameters (t1/2)
timeFrame: up to 57 days
measure: Second PK parameters (Vz/F)
timeFrame: up to 57 days
measure: Second PK parameters (CL/F)
timeFrame: up to 57 days
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Investigator site 0010209
state: Arizona
city: Lincoln
country: United States
facility: Investigator site 0010208
state: Nebraska
Study officials:
References: