Clinical trial NCT05556863: Evaluation of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ELA026 in Single and Multiple Doses in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Electra Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2022-09-27
Enrollment: 91
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability].
timeFrame: By week 3
Secondary outcomes:
measure: Plasma concentrations of ELA026
timeFrame: By week 3
measure: Change from baseline of monocytes levels.
timeFrame: By week 3
measure: Change from baseline of lymphocytes levels.
timeFrame: By week 3
measure: Presence of Anti-drug antibodies to ELA026
timeFrame: By week 3
measure: Comparison of ELA026 Maximum observed drug concentration (Cmax)
timeFrame: By week 3
measure: Comparison of ELA026 Area under the curve plasma concentration versus time curve (AUC)
timeFrame: By week 3
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion
state: Nebraska
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References: