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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: ELA026

• Registration Number: NCT05556863
• Lead Sponsor: Electra Therapeutics Inc.

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 Timeline

• Study Start: 2021-10-18
• Study First Submitted: 2022-09-20
• Study First Submitted QC: 2022-09-23
• Study First Posted: 2022-09-27
• Status Verified: 2023-10
• Primary Completion: 2023-11-20
• Study Completion: 2023-11-20
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part 2: Multiple Ascending Dose	ELA026	Cohort 1 - 6 Multi-dose: dose level, route (IV or SC) and frequency to be determined
Part 1: Single Ascending Dose	ELA026	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

Primary Outcome Measures

Name	Time	Method
Incidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability].	By week 3

Secondary Outcome Measures

Name	Time	Method
Plasma concentrations of ELA026	By week 3
Change from baseline of monocytes 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
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

Trial Locations

Locations (2)

Celerion; 🇺🇸 Lincoln, Nebraska, United States

Medical University of Vienna; 🇦🇹 Vienna, Austria