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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48123

Enrollment

Registered

2019-06-17

Start date

2019-07-01

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

immune thrombocytopenia myasthenia gravis

Interventions

Efgartigimod (1 of 4 doses) together with rHuPH20 will be given as a single injection under the skin in a total volume of approximately 4.7 mL to 10.8 mL. It is anticipated that the dose can be admi

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Secondary

Measure	Time frame
- To investigate the single-dose pharmacokinetics (PK) of four different subcutaneous dose levels of efgartigimod co-administered with rHuPH20 at 2,000 U/mL. - To investigate the safety, tolerability, and immunogenicity of four different subcutaneous dose levels of efgartigimod co-administered with rHuPH20 at 2,000 U/mL. - To assess the time required to administer the different volumes of efgartigimod co-administered with rHuPH20 SC.	—

Measure

Time frame

- To investigate the single-dose pharmacokinetics (PK) of four different subcutaneous dose levels of efgartigimod co-administered with rHuPH20 at 2,000 U/mL. - To investigate the safety, tolerability, and immunogenicity of four different subcutaneous dose levels of efgartigimod co-administered with rHuPH20 at 2,000 U/mL. - To assess the time required to administer the different volumes of efgartigimod co-administered with rHuPH20 SC.

—

Primary

Measure	Time frame
- To investigate the pharmacodynamics (PD) of four different subcutaneous dose levels of efgartigimod co-administered with rHuPH20 at 2,000 U/mL.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)