NL-OMON53550
Completed
N/A
A phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of OMS1029 with single-dose intravenous and subcutaneous administration in healthy subjects - OMS1029 IV SC First-in-human SAD study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Omeros Corporation
- Enrollment
- 48
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Sex: male or female.
- •2\. Age: 18 to 60 years, inclusive, at screening.
- •3\. Body mass index (BMI): 18\.0 to 30\.0 kg/m2, inclusive, at screening.
- •4\. Weight: 50 to 110 kg, inclusive, at screening.
- •5\. Status: healthy subjects.
- •6\. At screening, females must not be pregnant or lactating; nonpregnancy will
- •be confirmed for all females by a serum pregnancy test (minimum sensitivity 25
- •IU/L or equivalent units of β\-human chorionic gonadotropin \[β\-hCG]) at
- •screening and at admission.
- •7\. Females are a) not of childbearing potential (ie, surgically sterilized or
Exclusion Criteria
- •1\. Previous randomization in the current study.
- •2\. Employee of ICON 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 ICON employee.
- •3\. Received a complement inhibitor within 6 months of screening.
- •4\. History of relevant drug and/or food allergies. This includes any confirmed
- •significant allergic reactions (anaphylaxis or angioedema) to any drug, OMS1029
- •excipients, or multiple drug allergies (non\-active hay fever is allowed per the
- •Investigator\*s discretion).
Outcomes
Primary Outcomes
Not specified
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