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

Electra Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: ELA026

Study type: Interventional

Funder types: Industry

Identifiers

NCT05556863

ELA026-CP001

Details and patient eligibility

About

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.

Full 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

Enrollment: 91 patients

Sex: All

Ages: 19 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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91 participants in 2 patient groups

Part 1: Single Ascending Dose

Experimental group

Description:

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

Treatment:

Drug: ELA026

Drug: ELA026

Part 2: Multiple Ascending Dose

Experimental group

Description:

Cohort 1 - 6 Multi-dose: dose level, route (IV or SC) and frequency to be determined

Treatment:

Drug: ELA026

Drug: ELA026