Study to Evaluate the Safety, Tolerability and PK of EC-18 After Oral Administration in Healthy Volunteers

Enzychem Lifesciences Corporation64 enrolled

Overview

This study is a Dose block-randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Escalation, Phase I clinical trial to assess the safety, tolerability and pharmacokinetics of single-dose and multiple-dose oral administration of the investigational product, EC-18 (study drug) in healthy adult male volunteers.

In vitro and in vivo efficacy studies and clinical trials have shown that EC-18 has a mode of action of improving neutropenia by promoting neutrophil production from hematopoietic stem cells and at the same time, efficiently controlling STAT6/Complement 3(C3), suggesting its potential to be developed as an orally administered new drug for treatment of neutropenia resulting from decreased neutrophils caused by administration of an anticancer agent. This study is a Dose block-randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Escalation, Phase I clinical trial to assess the safety, tolerability and pharmacokinetics of single-dose and multiple-dose oral administration of the investigational product, EC-18 (study drug) in healthy adult male volunteers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Chemotherapy-Induced Neutropenia

Interventions

EC-18DRUG

EC-18 Soft-capsule (500mg/1 capsule)

PlaceboDRUG

Placebo with same shape and size

Eligibility

Sex: MALEMin age: 19 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy adult male aged between 19 and 45 years, inclusive, at the time of providing the informed consent form * Body weight ≥ 50 kg, and calculated BMI in the range of 18.5 kg/m2 ≤ BMI \< 25.0 kg/m2 ☞ BMI(body mass index) = Body weight (kg)/\[height (m)\]2 * No inherited or chronic disease and pathologic symptoms or findings from internal examinations * Eligible subject based on findings from clinical laboratory tests, such as hematology, blood chemistry, urinalysis and immunoserology, and ECG, as conducted by a responsible doctor depending on characteristics of the drug * Written consent on voluntary decision of participation and compliance with precautions after being fully informed of and completely understanding this trial * Consent to practice medically acceptable contraception during the trial Exclusion Criteria: * Hypersensitivity to a drug containing an ingredient of the investigational product (EC-18) or similar ingredient (e.g., deer antler) or other drugs (e.g., aspirin, antibiotics) or medical history of clinically significant hypersensitivity * Active infection such as chronic or local infection based on screening tests or inquiry, verifiable medical records * Serious infection that required hospitalization or use of antibiotics within 30 days prior to the first dose of the investigational product, based on an inquiry or verifiable medical records * Presence of a clinically significant hepatic, renal, gastrointestinal, respiratory, musculoskeletal, endocrine, nervous, blood, cardiovascular, urogenital, psychiatric disorder or its prior history * (1) Presenting tuberculosis or prior history of tuberculosis or (2) positive results from a QuantiFERON® -TB Gold in Tube Assay conducted due to a contact with a tuberculosis patient within the past 3 months or signs and symptoms of suspected tuberculosis * Prior history of a gastrointestinal disorder (e.g., Crohn's disease, ulcer) or surgery (except for simple appendectomy or hernia surgery) that may affect drug absorption, etc.

Locations (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

No. and severity of Adverse event as a Measure of Safety and Tolerability

Time frame: From date of D-1 until Follow-up visit: up to 30 days

Vital signs, physical examination, clinical laboratory tests, ECG as a Measure of Safety and Tolerability

Time frame: From date of screening until Follow-up visit: up to 60 days

Secondary Outcomes

Pharmacokinetic parameters of EC-18 following single oral dose: Cmax (Maximum observed plasma drug concentration)