inflammatory autoimmune disease
Conditions
Interventions
Group 1 day 1 OMS1029 0.01 mg/kg or placebo injection once into the bloodstream
Group 2 day 1 OMS1029 0.03 mg/kg or placebo injection once into the bloodstream
Group 3 day 1 OMS1029 0.1 mg/kg or place
Sponsors
Omeros Corporation
Eligibility
Age
18 Years to 64 Years
Inclusion 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 postmenopausal for >1 year); OR b) women of childbearing potential (WOCBP), and, if sexually active with a fertile male partner, must agree to use adequate contraception (see Section 3.4.8.1) from 4 weeks prior to Day 1 until 90 days following the final follow-up visit. 8. Males, if not documented surgically sterilized (eg, vasectomy and azoospermia) and sexually active with WOCBP partners, must agree to use adequate contraception (see Section 3.4.8.1) from admission (Day 1) until 90 days after the final follow-up visit. In addition, males must be willing to refrain from sperm donation during this time. 9. All prescribed medication must have been stopped at least 14 days prior to admission to the clinical research center. An exception is made for hormonal contraceptives, which may be used throughout the study. 10. All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John*s Wort) must have been stopped at least 7 days prior to admission to the clinical research center. An exception is made for paracetamol, which is allowed up to admission to the clinical research center. Furthermore, from admission onwards, the Investigator may permit a limited amount of paracetamol for the treatment of headache or any other pain. 11. Ability and willingness to abstain from alcohol during confinement and from 48 hours prior to admission and each ambulant visit to the clinical research center; and to limit alcohol use to no more than 2 units per day on average on all other study days (1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits). 12. Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG, telemetric monitoring (as applicable), and vital signs, as judged by the Investigator. 13. Competent, willing, and able to sign and understand the informed consent and any required privacy authorization prior to the initiation of any study procedures including a request that a subject fast for any laboratory evaluations and comply with protocol requirements.
Exclusion criteria
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). 5. Using tobacco and nicotine containing products within 30 days prior to the screening. 6. History of alcohol abuse or drug addiction (including soft drugs like cannabis products) within 1 years of screening or the unwillingness to agree to abstain from alcohol and drugs throughout the study. 7. Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at screening and admission to the clinical research center. 8. Average intake of more than 24 units of alcohol per week (1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits). 9. Positive screen for SARS-CoV-2 (if required by local regulation and guidelines), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) 1 and 2 antibodies. 10. Participation in a drug study within 30 days prior to study drug administration in the current study. Participation in 4 or more other drug studies in the 12 months prior to study drug administration in the current study. 11. Donation or loss of more than 450 mL of blood within 60 days prior to study drug administration. Donation or loss of more than 1500 mL of blood (for male subjects)/more than 1000 mL of blood (for female subjects) in the 10 months prior to study drug administration in the current study. 12. Plasma or platelet donation within 14 days prior to Day 1. 13. History of asplenia, hyposplenism, or splenectomy. 14. History of any significant medical, hematologic, liver, autoimmune, neurologic, or psychiatric disorder that in the opinion of the Investigator would make the patient unsuitable for participation in the study. 15. Any known skin condition that would affect SC dosing or interpretation of injection or infusion site reactions. 16. Any major surgery, in the opinion of the Investigator, that is planned during the study. 17. Inability to be venipunctured and/or tolerate venous access. This includes unsuitable veins for infusion or blood sampling. 18. Pregnancy or intent to conceive during the course of the study. 19. Inability to comply with all protocol assessments including follow-up visits. 20. Any other sound medical, psychiatric and/or social reason as determined by the Investigator. 21. Significant active bacterial or viral infection within the 2 weeks prior to screening. 22. Significant and/or acute illness within 5 days prior to study drug administration that may impact safety assessments, in the opinion of the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Adverse events (AEs), clinical laboratory, vital signs, 12-lead electrocardiogram (ECG), telemetric monitoring, physical examination, local tolerability, and presence of ADAs in serum | — |
Secondary
| Measure | Time frame |
|---|---|
| PK: Serum OMS1029 concentrations Serum PK parameters estimated using noncompartmental analysis, as appropriate: Cmax, tmax, kel, t1/2, AUC0-168, AUC0t, AUC0inf, %AUCextra, CL, CL/F, Vz, Vz/F, and F (absolute bioavailability for overlapping IV and SC dose levels) PD: Ex vivo lectin pathway activity level at baseline and % reduction as a function of time | — |
Countries
Netherlands
Outcome results
None listed