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

• Sponsor: Electra Therapeutics Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05556863
• Collaborator: (none)
• Enrollment: 120
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 17.4
• Patients Per Site: 60
• Patients Per Site Per Month: 3.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: ELA026; Drug: ELA026	Phase 1

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 3 MD cohorts

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Other
• 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
• Actual Study Start Date: Oct 18, 2021
• Anticipated Primary Completion Date: Apr 1, 2023
• Anticipated Study Completion Date: Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: ELA026; Single dose of ELA026
Experimental: Part 2: Multiple Ascending Dose Cohort 1 - 3 Multi-dose: dose level, route (IV or SC) and frequency to be determined	Drug: ELA026; Multiple doses of ELA026

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Plasma concentrations of ELA026 [By week 3]

2. Change from baseline of monocytes levels. [By week 3]

3. Change from baseline of lymphocytes levels. [By week 3]

4. Presence of Anti-drug antibodies to ELA026 [By week 3]

5. Comparison of ELA026 Maximum observed drug concentration (Cmax) [By week 3]

6. Comparison of ELA026 Area under the curve plasma concentration versus time curve (AUC) [By week 3]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Celerion	Lincoln	Nebraska	United States	68502
2	Medical University of Vienna	Vienna		Austria

Sponsors and Collaborators

• Electra Therapeutics Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Electra Therapeutics Inc.
• ClinicalTrials.gov Identifier: NCT05556863
• Other Study ID Numbers: ELA026-CP001
• First Posted: Sep 27, 2022
• Last Update Posted: Sep 27, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 27, 2022