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Monoclonal Antibodies

Efgartigimod PH20 SC - prefilled syringe for Bioequivalence

Phase 1
Waitlist Available
Research Sponsored by argenx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 85 days
Awards & highlights

Study Summary

This trial compares the effects of two doses of a drug on healthy people, to see which works best.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 85 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 85 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary PK parameters (AUC0-inf)
Primary PK parameters (Cmax)
Secondary outcome measures
Incidence of ADA against efgartigimod PH20 SC
Safety parameters (number of AEs)
Second PK parameters (AUC0-168h)
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Efgartigimod PH20 SC - prefilled syringeExperimental Treatment1 Intervention
efgartigimod PH20 SC administered by a prefilled syringe
Group II: Efgartigimod PH20 SC - vial + syringeActive Control1 Intervention
efgartigimod PH20 SC administered by a vial + syringe
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
efgartigimod PH20 SC as a prefilled syringe presentation
2023
Completed Phase 1
~120

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

argenxLead Sponsor
60 Previous Clinical Trials
9,150 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this investigation accept applicants over the age of 40?

"The minimum age of admission for this clinical trial is 18 and the upper threshold is 55."

Answered by AI

Are there any eligibility criteria for individuals to become involved in this research project?

"To qualify for this trial, candidates must be within the age bracket of 18 to 55 and demonstrate bioequivalence. In total, 120 patients will be accepted."

Answered by AI

Has the FDA sanctioned Efgartigimod PH20 SC in pre-filled syringes?

"There is limited clinical data affirming the safety and efficacy of Efgartigimod PH20 SC - prefilled syringe, so it received a ranking of 1."

Answered by AI

What is the magnitude of individuals involved in this trial?

"Affirmative. According to information hosted on clinicaltrials.gov, this trial is still recruiting participants as of April 5th 2023 - the last time it was updated. The research requires 120 volunteers from 2 distinct medical sites and has been publicised since March 13th 2023."

Answered by AI

Are there still available positions for individuals to participate in this investigation?

"Affirmative. The clinicaltrials.gov database reveals that this research study, which was initially uploaded on March 13th 2023, is actively recruiting individuals for participation. It requires a total of 120 participants to be enrolled from 2 different sites."

Answered by AI
~60 spots leftby Mar 2025