NL-OMON49985CompletedNot Applicable
A phase 1, randomized, open-label, parallel-group study to compare the pharmacodynamics, pharmacokinetics, safety, and tolerability of multiple intravenous infusions of efgartigimod with multiple subcutaneous injections of efgartigimod PH20 SC in healthy subjects. - Comparing PK, PD, safety of efgartigimod SC and IV.
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- argenx BV
- Enrollment
- 54
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •Healthy, adult males and females of non-childbearing potential between 18-65
- •years of age, inclusively, with a BMI between 18-30 kg/m2, and body weight
- •between 50-100 kg.
Exclusion Criteria
- •1. The subject has previously participated in clinical studies with
- •efgartigimod (ARGX-113).
- •2. The subject has a known hypersensitivity to one of the components in the
- •IMP, or a history of severe allergic or anaphylactic reactions, in the opinion
- •of the investigator.
- •3. The subject tests positively at screening for any of the following
- •conditions:
- •a. an active hepatitis B infection (acute or chronic) at screening as
- •determined by HepB serology
- •b. Hepatitis C Virus (HCV): serology positive for HCV-Ab
- •c. HIV positive serology
- •4. Subjects with clinically significant active or chronic uncontrolled
- •bacterial, viral, or fungal infection at screening.
- •5. Subjects with clinical evidence of other significant serious diseases,
- •subjects who underwent a recent major surgery, or any other reason which could
- •confound the results of the trial or put the subject at undue risk.
- •For more exclusion criteria see Protocol.
Investigators
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