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
Completed
- Conditions
- immune thrombocytopeniamyasthenia gravis10003816
- Registration Number
- NL-OMON48123
- Lead Sponsor
- argenx BVBA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 32
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
the trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- To investigate the pharmacodynamics (PD) of four different subcutaneous dose<br /><br>levels of efgartigimod co-administered with rHuPH20 at 2,000 U/mL.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To investigate the single-dose pharmacokinetics (PK) of four different<br /><br>subcutaneous dose levels of efgartigimod co-administered with rHuPH20 at 2,000<br /><br>U/mL.<br /><br>- To investigate the safety, tolerability, and immunogenicity of four different<br /><br>subcutaneous dose levels of efgartigimod co-administered with rHuPH20 at 2,000<br /><br>U/mL.<br /><br>- To assess the time required to administer the different volumes of<br /><br>efgartigimod co-administered with rHuPH20 SC.</p><br>