NL-OMON48123CompletedNot Applicable
A phase 1, randomized, open-label, parallel group trial to investigate the pharmacodynamics, pharmacokinetics, safety, and tolerability of different single subcutaneous dose levels of Efgartigimod co administered with rHuPH20 in healthy adult male subjects - Efgartigimod co-administered with rHuPH20 in healthy subjects
argenx BVBA0 sites32 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 32
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •- healthy male subjects
- •- 18-70 yrs, inclusive
- •- BMI: 18.0-30.0 kg/m2, inclusive and with a body weight of at least 50 kg and
- •no more than 100 kg prior to dosing.
Exclusion Criteria
- •Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. Previous
- •participation in clinical trials with efgartigimod (ARGX-113) and/or any
- •products co-formulated with rHuPH20. Significant blood loss (including blood
- •donation >500 mL) or transfusion of any blood product within 12 weeks prior to
- •the IMP administration or scheduled transfusion within 4 weeks after the end of
Investigators
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