A phase I study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple-dose subcutaneous and intravenous administration of OMS721 in healthy subjects

Completed

Conditions: autoimmune diseases
10003816

Registration Number: NL-OMON42466

Lead Sponsor: Omeros Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

Inclusion Criteria

healthy volunteers
18-54 years, inclusive
BMI: 19.0-32.0 kg/m2, inclusive

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 0.5 liters of blood in the 60 days prior the start of this study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* Evaluate the safety and tolerability of multiple-dose subcutaneous (SC) and<br /><br>intravenous (IV) administration of OMS721 in healthy subjects<br /><br>* Evaluate the pharmacokinetics (PK) of multiple-dose SC and IV administration<br /><br>of OMS721 in healthy subjects<br /><br>* Evaluate the PK of an IV loading dose followed by SC administration of OMS721<br /><br>in healthy subjects</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Evaluate the pharmacodynamics (PD) of multiple-dose SC and IV administration<br /><br>of OMS721 in healthy subjects<br /><br>* Evaluate the PD of an IV loading dose followed by SC administration of OMS721<br /><br>in healthy subjects<br /><br>* Evaluate the anti-drug antibody (ADA) response following multiple-dose SC and<br /><br>IV administration of OMS721 in healthy subjects<br /><br>* Explore the effect of baseline mannan-binding lectin (MBL) and mannan-binding<br /><br>lectinassociated serine protease-2 (MASP-2) plasma concentrations on OMS721<br /><br>pharmacodynamics<br /><br>* Explore the effect of OMS721 on MASP-2 and MBL plasma concentrations<br /><br>* Explore the effect of OMS721 on the classical and alternative complement<br /><br>pathways<br /><br>* Explore the size and duration of the effect of posture on total IgG plasma<br /><br>concentration</p><br>