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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05556863
• Other study ID #: ELA026-CP001
• Status: Completed
• Phase: Phase 1
• Start date: October 18, 2021
• Est. completion date: November 20, 2023

Study information

• Verified date: October 2023
• Source: Electra Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: November 20, 2023
• Est. primary completion date: November 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• ELA026
Single dose of ELA026
• ELA026
Multiple doses of ELA026

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna
United States	Celerion	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Electra Therapeutics Inc.

Countries where clinical trial is conducted

United States,  Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability].		By week 3
Secondary	Plasma concentrations of ELA026		By week 3
Secondary	Change from baseline of monocytes levels.		By week 3
Secondary	Change from baseline of lymphocytes levels.		By week 3
Secondary	Presence of Anti-drug antibodies to ELA026		By week 3
Secondary	Comparison of ELA026 Maximum observed drug concentration (Cmax)		By week 3
Secondary	Comparison of ELA026 Area under the curve plasma concentration versus time curve (AUC)		By week 3