Evaluation of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ELA026 in Single and Multiple Doses in Healthy Volunteers
Completed · Phase 1
Conditions studied: Healthy Volunteers
In brief
ELA026 is a fully human IgG1 SIRP-directed monoclonal antibody designed to reduce the myeloid and T cells driving the inflammation. The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ELA026 in Single and Multiple Doses in Healthy Adults.
Key facts
- Study ID
- NCT05556863
- Run by
- Electra Therapeutics Inc.
- People needed
- 91
- Starts
- 2021-10-18
- Expected to finish
- 2023-11-20
- Last updated by the study team
- 2024-03-27
Who can join
Age: 19 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Non-Japanese subjects 19 to 60 years of age. Japanese subjects 20 to 60 years of age.
- Must be in good general health.
- No clinically significant abnormal laboratory values during screening.
- Body mass index of 18 - 32 kg/m2.
You may not qualify if…
- Clinical diagnosis or laboratory evidence of renal, hepatic, central nervous system, respiratory, cardiovascular, or metabolic disease at Screening.
- Diagnosed with any form of malignancy (except basal cell carcinoma, fully removed).
- Clinically significant immunodeficiency or autoimmunity assessed by medical history and/or laboratory test results.
- Active or latent tuberculosis (TB), regardless of treatment history,
- Positive drug abuse test.
- Positive HIV, HBV, HCV test results.
- Clinically significant ECG test results.
- Clinically significant vital sign results.
Where it is running
- Celerion — Lincoln, Nebraska, United States
- Medical University of Vienna — Vienna, Austria
Full record on ClinicalTrials.gov
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