A study to determine the safety of higher doses of OMS906 in healthy volunteers
| ISRCTN | ISRCTN16253842 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16253842 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 1008854 |
| Protocol serial number | OMS906-NHV-004 |
| Sponsor | Omeros Corporation (United States) |
| Funder | Omeros Corporation |
- Submission date
- 22/02/2024
- Registration date
- 23/02/2024
- Last edited
- 15/12/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
The purpose of this study was to test a drug called OMS906 that is being developed for the treatment of inflammatory and autoimmune diseases, such as paroxysmal nocturnal haemoglobinuria (PNH). PNH is a rare blood condition where blood cells are attacked and destroyed by the immune system (the body’s defence mechanism against infections and diseases). This was a study in healthy volunteers to investigate the safety of higher doses of OMS906. The other aims of the study were to see how the body absorbs and removes the study drug and to assess the effect of the study drug on the body.
Who can participate?
People who met certain criteria could participate, but in general, participants were male or female healthy volunteers aged between 18 and 60 years old, with a body mass index of between 18.0 and 30.0 kg/m2 and weight between 50 and 110 kg.
What does the study involve?
Participation in the study lasted approximately 29 weeks, with up to 13 visits to a Clinical Research Unit (including one 4 night stay). Participants either received a single dose of OMS906 or placebo (dummy drug) and had various tests including ECG, blood and urine tests.
What are the possible benefits and risks of participating?
There were no benefits to participating, apart from contribution to scientific knowledge which may lead to the expansion of treatment options for people with PNH. Risks from taking OMS906 included bacterial infections, temporary increases in heart rate, liver enzymes and white and red blood cell counts. There were also risks associated with drawing blood, taking ECGs and risks associated with vaccines for meningitis, which may have needed to be administered before the study start.
Where is the study run from?
MAC Clinical Research (UK)
When is the study starting and how long is it expected to run for?
The study started in March 2024 and ended in April 2025
Who is funding the study?
Omeros Corporation (USA)
Who is the main contact?
MAC Clinical Research
Contact information
Public, Scientific
201 Elliott Avenue West
Seattle
98119
United States of America
| Phone | +1 206-676-5000 |
|---|---|
| ctinfo@omeros.com |
Principal investigator
Citylabs 1.0, Nelson Street
Manchester
M13 9NQ
United Kingdom
| Phone | +44 0161 274 1603 |
|---|---|
| ashleybrooks@macplc.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized double-blind single-centre placebo-controlled single-dose study in two sequential groups of healthy male and/or female subjects each |
| Secondary study design | Randomised controlled trial |
| Scientific title | A Phase I study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of higher doses of OMS906 by single dose intravenous administration in healthy subjects |
| Study acronym | OMS906-NHV-004 |
| Study objectives | The primary objective of the study is to assess the safety and tolerability of single dose 8 mg/kg and 10 mg/kg or 12 mg/kg intravenous OMS906. The secondary objectives of the study were: 1. To assess the pharmacokinetics of OMS906. 2. To assess the pharmacodynamics of OMS906. 3. To assess anti-drug antibodies (ADAs) following single dose 8 mg/kg and 10 mg/kg or 12 mg/kg IV OMS906. |
| Ethics approval(s) |
1. Approved 11/01/2024, Wales Research Ethics Committee 1 (Health and Care Research Wales, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, United Kingdom; +44 2920 785738; Wales.REC1@wales.nhs.uk), ref: 23/WA/0330 2. Approved 12/01/2024, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, United Kingdom; +44 (0) 20 3080 6000;; info@mhra.gov.uk), ref: 49709/0006/001-0001 |
| Health condition(s) or problem(s) studied | 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 |
| Intervention | 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 approximately 140 days. A simple randomisation schedule has been produced using Statistical Analysis System Procedure (SAS PROC) PLAN and code break envelopes are available for the Investigator to open in an emergency. |
| Intervention type | Drug |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Zaltenibart (OMS906) |
| Primary outcome measure(s) |
1. Safety and tolerability measured using Adverse Event monitoring at Day -1 to Day 140 |
| Key secondary outcome measure(s) |
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 |
| Completion date | 30/04/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | All |
| Target sample size at registration | 16 |
| Total final enrolment | 16 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 06/03/2024 |
| Date of final enrolment | 10/12/2024 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Nelson St
Manchester
M13 9NQ
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 15/12/2025 | 15/12/2025 | No | No |
Additional files
- ISRCTN16253842_BasicResults_15Dec2025.pdf
- Basic results
Editorial Notes
15/12/2025: The information for which publication was previously deferred has been added to the following fields:
1. Public title
2. Scientific title
3. Study acronym
4. Study objectives
5. Study design
6. Health condition(s) or problem(s) studied
7. Interventions
8. Intervention type
9. Phase
10. Drug/device/biological/vaccine name(s)
11. Primary and secondary outcome measures
12. Key inclusion and exclusion criteria
13. Lower and upper age limits and units
14. Final enrolment
15. Plain English summary of protocol
16. Basic results uploaded
17. The date of first enrolment was changed from 29/02/2024 to 06/03/2024
18. The date of final enrolment was changed from 30/10/2024 to 10/12/2024
19. The completion date was changed from 30/10/2024 to 30/04/2025
20. The study contacts and study participating centres were updated.
22/02/2024: Trial's existence confirmed by Wales Research Ethics Committee 1.
