A phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of OMS1029 with single-dose intravenous and subcutaneous administration in healthy subjects

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.

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.