A Safety and PK Study of EC-18 in Healthy Subjects

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

NCT02496143

EC-18-001

Details and patient eligibility

About

The purpose of this study is to determine if EC-18 is safe and tolerable in healthy subjects.

Full description

This will be a randomized, double-blind, placebo-controlled study of the safety, tolerability, PK, and pharmacodynamics of single ascending doses of EC-18 or placebo. If no dose limiting toxicity (DLT) is observed in Cohort One, the dose of EC-18 will be increased to in Cohorts Two, Three, and Four, respectively. Dose escalation to each successive cohort of subjects will not occur until a review of the safety and tolerability data from the previous cohort is completed and the Investigator, Sponsor, and study Medical Monitor together confirm the safety and tolerability of EC-18 given at that dose level.

Enrollment: 33 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Females of childbearing potential must use an acceptable birth control method throughout the study and for 14 days after the dose of study drug.
• Females of non-childbearing potential (defined as surgically sterilized [tubal ligation/hysterectomy/bilateral salpingo-oophorectomy] or postmenopausal for >2 years) with a negative urine human chorionic gonadotropin pregnancy test at the Screening Visit.
• Males willing to practice contraception (condom + spermicide) during the study and for 14 days after completion of the study, or who have a female partner using barrier or oral contraception during that timeframe.
• Body mass index (BMI) between 18 and 32 kg/m2, inclusive.
• Ability to understand and give informed consent and provide authorization for use of protected health information (Health Insurance Portability and Accountability Act).
• Willing and able to be confined to the research clinic as required by the protocol.

Exclusion criteria

• Febrile (temperature ≥99.5°F/37.5°C) at the Screening Visit or at admission to the research clinic on Day -1.

• Clinically significant laboratory findings at the Screening Visit defined as the following:

  • Alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin >1.5 x upper limit of normal (ULN)
  • Blood urea nitrogen (BUN), creatinine >1.25 x ULN
  • White blood cell (WBC) count <0.9 x lower limit of normal (LLN) or >1.1 x ULN
  • Hemoglobin or hematocrit <0.9 x LLN or >1.1 x ULN
  • Platelet count <0.9 x LLN or >1.1 x ULN
  • Glucose <0.9 x LLN or >1.25 x ULN
  • Thyroid-stimulating hormone (TSH) <0.75 x LLN or >1.25 x ULN or any other laboratory, ECG, vital sign, or physical abnormality that, in the investigator's opinion, unfavorably increases the risk of study participation.

• Positivity for human immunodeficiency virus (HIV) or receiving active antiretroviral therapy, hepatitis B surface antigen positivity, or hepatitis C positivity.

• History of drug or alcohol abuse within the past 2 years.

• Females who are pregnant or intend to get pregnant over the next month.

• Positive urine pregnancy test at the Screening Visit or at admission to the research clinic on Day -1.

• Positive urine drug or breath alcohol test at the Screening Visit or at admission to the research clinic on Day -1. Subjects should be instructed not to drink alcohol within 12 hours of the screening assessment.

• Intake of alcohol within 72 hours prior to study drug administration or intake of grapefruit or Seville oranges within 7 days prior to the administration of study drug.

• Strenuous physical exercise within 48 hours prior to study drug administration.

• Administration of any over-the-counter medication, dietary supplements, or vitamins within 7 days prior to study drug administration. Excluded from this list is nondaily use of acetaminophen at doses of ≤2 grams over a 24-hour period.

• Administration of prescription drugs or herbal supplements within 14 days prior to study drug administration.

  -.Exposure to any investigational agent within 30 days prior to the Screening Visit.

• Any current medical illness, signs, or symptoms that, in the investigator's opinion, could adversely affect subject safety or study integrity.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

---

33 participants in 4 patient groups

Cohort 1

Experimental group

Description:

500 mg EC-18 dose or placebo

Treatment:

Drug: Placebo

Drug: EC-18

Cohort 2

Experimental group

Description:

1000 mg EC-18 dose orplacebo

Treatment:

Drug: Placebo

Drug: EC-18

Cohort 3

Experimental group

Description:

2000 mg EC-18 dose or placebo

Treatment:

Drug: Placebo

Drug: EC-18

Cohort 4

Experimental group

Description:

4000 mg EC-18 dose or placebo

Treatment:

Drug: Placebo

Drug: EC-18