Evaluation of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ELA026 in Single and Multiple Doses in Healthy Volunteers

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: ELA026; Drug: ELA026

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 Type: Interventional
• Enrollment (Actual): 91
• Phase: Phase 1

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • Medical University of Vienna
• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Non-Japanese subjects 19 to 60 years of age. Japanese subjects 20 to 60 years of age.
2. Must be in good general health.
3. No clinically significant abnormal laboratory values during screening.
4. Body mass index of 18 - 32 kg/m2.

Exclusion Criteria:

1. Clinical diagnosis or laboratory evidence of renal, hepatic, central nervous system, respiratory, cardiovascular, or metabolic disease at Screening.
2. Diagnosed with any form of malignancy (except basal cell carcinoma, fully removed).
3. Clinically significant immunodeficiency or autoimmunity assessed by medical history and/or laboratory test results.
4. Active or latent tuberculosis (TB), regardless of treatment history,
5. Positive drug abuse test.
6. Positive HIV, HBV, HCV test results.
7. Clinically significant ECG test results.
8. Clinically significant vital sign results.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: ELA026; Single dose of ELA026; Drug: ELA026; Multiple doses of ELA026
Experimental: Part 2: Multiple Ascending Dose; Cohort 1 - 6 Multi-dose: dose level, route (IV or SC) and frequency to be determined	Drug: ELA026; Single dose of ELA026; Drug: ELA026; Multiple doses of ELA026

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability].	By week 3

Secondary Outcome Measures

Outcome Measure	Time Frame
Plasma concentrations of ELA026	By week 3
Change from baseline of monocytes levels.	By week 3
Change from baseline of lymphocytes levels.	By week 3
Presence of Anti-drug antibodies to ELA026	By week 3
Comparison of ELA026 Maximum observed drug concentration (Cmax)	By week 3
Comparison of ELA026 Area under the curve plasma concentration versus time curve (AUC)	By week 3

Collaborators and Investigators

• Sponsor: Electra Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2021
• Primary Completion (Actual): November 20, 2023
• Study Completion (Actual): November 20, 2023

Study Registration Dates

• First Submitted: September 20, 2022
• First Submitted That Met QC Criteria: September 23, 2022
• First Posted (Actual): September 27, 2022

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: ELA026-CP001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No