'A phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single-dose intravenous and subcutaneous administration and multiple-dose subcutaneous administration of OMS906 in healthy subjects'

Withdrawn

Conditions: blood disease that causes red blood cells to break apart
10038158

Registration Number: NL-OMON49225

Lead Sponsor: Omeros Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

1. Sex : male or female.
2. Age : 18 to 54 years, inclusive, at Screening.
3. Body mass index : 22.0 kg/m2 to 30.0 kg/m2 inclusive.
4. Status : healthy subjects.

Exclusion Criteria

1. Previous participation in the current study.
2. Employee of PRA or the Sponsor, or their immediate family member. Immediate
family is defined as current spouse, parent, natural or legally adopted child
(including a stepchild living in the household), grandparent, or grandchild of
Omeros or PRA employee.
3. History of relevant drug and/or food allergies (this includes known
allergies for antimeningococcal antibiotic treatment 19).
4. Using tobacco products within 30 days prior to the Screening.
5. History of alcohol abuse or drug addiction (including soft drugs like
cannabis products) within 3 years of Screening.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Part A: Single Ascending Dose (SAD)<br /><br>• To assess the safety and tolerability of OMS906, when administered as single<br /><br>ascending IV and SC doses in healthy subjects.<br /><br><br /><br>Part B: Multiple Ascending Dose (MAD)<br /><br>• To assess the safety and tolerability of OMS906, when administered as<br /><br>multiple ascending SC doses in healthy subjects.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Part A: SAD<br /><br>• To characterize the PK of OMS906, when administered as single ascending IV<br /><br>and SC doses in healthy subjects.<br /><br>• To characterize the PD of OMS906, when administered as single ascending IV<br /><br>and SC doses in healthy subjects.<br /><br>• To assess the presence of anti-drug antibodies (ADA) against OMS906 after<br /><br>single ascending IV and SC doses in healthy subjects.<br /><br><br /><br>Part B: MAD<br /><br>• To characterize the PK of OMS906, when administered as multiple ascending SC<br /><br>doses in healthy subjects.<br /><br>• To characterize the PD of OMS906, when administered as multiple ascending SC<br /><br>doses in healthy subjects.<br /><br>• To assess the presence of ADAs against OMS906 after multiple ascending SC<br /><br>doses in healthy subjects.</p><br>