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

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

Inclusion criteria

• Non-Japanese subjects 19 to 60 years of age. Japanese subjects 20 to 60 years of age.
• Must be in good general health.
• No clinically significant abnormal laboratory values during screening.
• Body mass index of 18 - 32 kg/m2.

Exclusion criteria

• Clinical diagnosis or laboratory evidence of renal, hepatic, central nervous system, respiratory, cardiovascular, or metabolic disease at Screening.
• Diagnosed with any form of malignancy (except basal cell carcinoma, fully removed).
• Clinically significant immunodeficiency or autoimmunity assessed by medical history and/or laboratory test results.
• Active or latent tuberculosis (TB), regardless of treatment history,
• Positive drug abuse test.
• Positive HIV, HBV, HCV test results.
• Clinically significant ECG test results.
• Clinically significant vital sign results.