A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ELA026 Following Intravenous and/or Subcutaneous Administration of Single and Multiple Doses in Healthy Adults
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Electra Therapeutics Inc.
- Enrollment
- 91
- Locations
- 2
- Primary Endpoint
- Incidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability].
Study Overview
Brief Summary
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.
Detailed Description
This is a multi-center, Phase 1, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, PK, and PD of ELA026 following single and multiple IV and/or SC dose administration in healthy adult volunteers, including a subgroup of Japanese volunteers.
The study will consist of 2 parts:
- Part 1: single ascending doses (SAD) in up to 11 SAD cohorts plus a Japanese cohort
- Part 2: multiple doses (MD) up to 6 MD cohorts
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Other
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 19 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Part 1: Single Ascending Dose
Cohort 1 Single dose: 0.001 mg/kg IV
Cohorts 2 - 11 Single dose: dose level and route (IV or SC) to be determined
Japanese Cohort Single dose: dose level and route (IV or SC) to be determined
Intervention: ELA026 (Drug)
Part 2: Multiple Ascending Dose
Cohort 1 - 6 Multi-dose: dose level, route (IV or SC) and frequency to be determined
Intervention: ELA026 (Drug)
Outcomes
Primary Outcomes
Incidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability].
Time Frame: By week 3
Secondary Outcomes
- Presence of Anti-drug antibodies to ELA026(By week 3)
- Plasma concentrations of ELA026(By week 3)
- Comparison of ELA026 Maximum observed drug concentration (Cmax)(By week 3)
- Change from baseline of monocytes levels.(By week 3)
- Change from baseline of lymphocytes levels.(By week 3)
- Comparison of ELA026 Area under the curve plasma concentration versus time curve (AUC)(By week 3)