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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-18

Study Completion Date

2023-11-20

Brief Summary

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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.

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Detailed Description

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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

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type EXPERIMENTAL

ELA026

Intervention Type DRUG

Single dose of ELA026

Part 2: Multiple Ascending Dose

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

Group Type EXPERIMENTAL

ELA026

Intervention Type DRUG

Multiple doses of ELA026

Interventions

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ELA026

Single dose of ELA026

Intervention Type DRUG

ELA026

Multiple doses of ELA026

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes