NCT05556863

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Electra Therapeutics Inc. · Industry
• Sex: All
• Age: 19 Years – 60 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	ELA026	Single dose of ELA026
DRUG	ELA026	Multiple doses of ELA026

Timeline

• Start date: 2021-10-18
• Primary completion: 2023-11-20
• Completion: 2023-11-20
• First posted: 2022-09-27
• Last updated: 2024-03-27

Locations

2 sites across 2 countries: United States, Austria

Regulatory

• FDA-regulated drug study