OMS906 is being developed to treat inflammatory and autoimmune diseases, such as paroxysmal nocturnal haemoglobinuria (PNH), a rare blood condition where blood cells are attacked and destroyed by the immune system Other
Conditions
Interventions
OMS906 and placebo are administered by IV infusion over 30 minutes. Each subject receives a single dose of either OMS906 (8 mg/kg or 12 mg/kg) or placebo on Day 0 of the study and are followed up for
Sponsors
Omeros Corporation (United States)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male or female aged =18 and =60 years at Screening. 2. Body mass index (BMI) =18.0 and =30.0 kg/m2 and total body weight =50 kg and =110 kg at Screening. 3. Non pregnancy of female participants confirmed. Male and female contraceptive requirements. 4. Cessation of all prescribed medications (excluding the contraceptive pill) at least 14 days prior to admission to the Clinical Research Unit (CRU). 5. Cessation of all over the counter medications, vitamin preparations and other food supplements or herbal medications at least 7 days prior to admission to the CRU (except paracetamol/acetaminophen, which was permitted up to admission to the CRU). 6. Ability and willingness to abstain from alcohol use for the 48 hours prior to admission to the CRU and throughout confinement. 7. Good physical and mental health based on medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the Investigator. 8. Mandatory documentation of prior N. meningitidis vaccination (MenABCWY), otherwise participant was to start vaccinations or receive boosters during Run-In.
Exclusion criteria
Exclusion criteria: 1. Receipt of a complement inhibitor within 6 months of Screening. 2. History of any significant allergic, medical, haematologic, neurologic, or psychiatric disorder or social reason that in the opinion of the Investigator would have made the subject unsuitable for participation in the study. 3. Subjects with values greater than the upper limit of normal (ULN) for the following laboratory tests: creatinine, creatine phosphokinase (CPK), LDH, alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin and direct bilirubin that remained elevated on repeat sampling and analysis 4. Significant active bacterial or viral infection or acute illness within 2 weeks prior to Screening including coronavirus disease 2019 (COVID-19) infection. 5. Positive screen for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigen on nasal swab, or the hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) 1 and 2 antibodies in blood. 6. Plasma or platelet donation within 14 days prior to Day 0. 7. History of asplenia, hyposplenism, or splenectomy. 8. History of significant autoimmune disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety and tolerability measured using Adverse Event monitoring at Day -1 to Day 140 2. Safety and tolerability measured using vital signs at Day -1, 0, 1, 2, 3, 4-6, 7, 28, 56, 84, 112, 140 3. Safety and tolerability measured using 12-lead ECGs at Day 0, 1, 2, 3, 4-6, 7, 28, 56, 84, 112, 140 4. Safety and tolerability measured using clinical laboratory tests at Day -1, 3, 7, 28, 56, 84, 112, 140 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. OMS906 pharmacokinetics (PK) measured using serum OMS906 concentrations for PK parameters at Day 0, 1, 2, 3, 4-6, 7, 28, 56, 84, 112, 140 2. OMS906 pharmacodynamics measured using change from baseline in MASP-3 and mature CFD in plasma at Day 0, 1, 2, 3, 4-6, 7, 28, 56, 84, 112, 140 3. Anti-Drug Antibodies (ADAs) measured using incidence of subjects with ADAs in serum at Day 0, 28, 56, 84, 112, 140 | — |
Countries
England, United Kingdom
Contacts
Public ContactOmeros Corporation
Outcome results
None listed