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

Enzychem Lifesciences

Status and phase: Completed; Phase 1

Conditions: Chemotherapy-Induced Neutropenia

Treatments: Drug: EC-18; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02532712

EC-18-101

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 64 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 16 patient groups, including a placebo group

Single dose group-Group 1-Experimental

Experimental group

Description:

Single dose, 500mg of Study drug(EC-18)

Treatment:

Drug: EC-18

Single dose group-Group 1-Placebo

Placebo Comparator group

Description:

Single dose, 500mg of Placebo

Treatment:

Drug: Placebo

Single dose group-Group 2-Experimental

Experimental group

Description:

Single dose, 1000mg of Study drug(EC-18)

Treatment:

Drug: EC-18

Single dose group-Group 2-Placebo

Placebo Comparator group

Description:

Single dose, 1000mg of Placebo

Treatment:

Drug: Placebo

Single dose group-Group 3-Experimental

Experimental group

Description:

Single dose, 2000mg of Study drug (EC-18)

Treatment:

Drug: EC-18

Single dose group-Group 3-Placebo

Placebo Comparator group

Description:

Single dose, 2000mg of Placebo

Treatment:

Drug: Placebo

Single dose group-Group 4-Experimental

Experimental group

Description:

Single dose, 4000mg of Study drug (EC-18)

Treatment:

Drug: EC-18

Single dose group-Group 4-Placebo

Placebo Comparator group

Description:

Single dose, 4000mg of Placebo

Treatment:

Drug: Placebo

Multiple dose group-Group 1-Experimental

Experimental group

Description:

Multiple dose, Study drug(EC-18) 500mg, Once daily, for 14 days

Treatment:

Drug: EC-18

Multiple dose group-Group 1-Placebo

Placebo Comparator group

Description:

Multiple dose, Placebo 500mg, Once daily, for 14 days

Treatment:

Drug: Placebo

Multiple dose group-Group 2-Experimental

Experimental group

Description:

Multiple dose, Study drug(EC-18) 1000mg, Once daily, for 14 days

Treatment:

Drug: EC-18

Multiple dose group-Group 2-Placebo

Placebo Comparator group

Description:

Multiple dose, Placebo 1000mg, Once daily, for 14 days

Treatment:

Drug: Placebo

Multiple dose group-Group 3-Experimental

Experimental group

Description:

Multiple dose, Study drug(EC-18) 2000mg, Once daily, for 14 days

Treatment:

Drug: EC-18

Multiple dose group-Group 3-Placebo

Placebo Comparator group

Description:

Multiple dose, Placebo 2000mg, Once daily, for 14 days

Treatment:

Drug: Placebo

Multiple dose group-Group 4-Experimental

Experimental group

Description:

Multiple dose, Study drug(EC-18) 4000mg, Once daily, for 14 days

Treatment:

Drug: EC-18

Multiple dose group-Group 4-Placebo

Placebo Comparator group

Description:

Multiple dose, Placebo 4000mg, Once daily, for 14 days

Treatment:

Drug: Placebo