Clinical Trials Logo
  1. Home
  2. Chemotherapy-Induced Neutropenia
  3. NCT02496143

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

Chemotherapy-induced Neutropenia Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Administration of EC-18 in Healthy Subjects

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02496143
Study type Interventional
Source Enzychem Lifesciences Corporation
Contact
Status Completed
Phase Phase 1
Start date July 2015
Completion date December 2015
View Details
See also
  Status Clinical Trial Phase
Completed NCT02643901 - Tolerability and Pharmacokinetics(PK)/Pharmacodynamics(PD) Study of GW003 in Healthy Subjects Phase 1
Completed NCT02251977 - Effect of GM1 in Prevention of Oxaliplatin Induced Neurotoxicity in Stage II/III Colorectal Cancer Phase 3
Terminated NCT02454530 - Use of Biosimilar Nivestim® to Prevent Chemo-induced Neutropenia. Real Life Study
Active, not recruiting NCT02104830 - Study of the Efficacy and Safety of Empegfilgrastim for Neutropenia Prophylaxis in Cancer Patients Phase 3
Completed NCT04914702 - Feasibility and Comparison of Continuously Monitored Vital Signs in Pediatric Patients With Cancer.
Active, not recruiting NCT03294577 - Plinabulin vs. Pegfilgrastim in Prevention of TAC Induced Neutropenia Phase 3
Not yet recruiting NCT03701841 - Efficacy, Safety and Cost-effectiveness of PEG-rhG-CSF for Primary vs Secondary Prophylaxis
Completed NCT00776165 - Safety and Efficacy Trial of Recombinant Human Granulocyte Colony Stimulating Factor (GCSF) Phase 3
Completed NCT03251768 - Recombinant Human Serum Albumin/Granulocyte Colony Stimulating Factor Fusion Protein for Breast Cancer Patients Phase 2
Recruiting NCT04101760 - Granulocyte Colony Stimulating Factor for for the Prevention of Febrile Neutropenia in Epithelial Ovarian Cancer Phase 3
Completed NCT04134429 - Feasibility of Monitoring Health Data in Pediatric Patients Undergoing Chemotherapy
Completed NCT04227990 - Plinabulin iv Solution in Prevention of TAC Induced Neutropenia Phase 2
Completed NCT03102606 - Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 3 Phase 3
Completed NCT01569087 - Dose-finding Study of Empegfilgrastim for Neutropenia Prophylaxis in Cancer Patients Phase 2
Completed NCT05512676 - Trabectedin/Caelyx vs Cisplatin Hypersensitivity in Relapsed Ovarian Cancer Patients Allergic to Platinum
Completed NCT04460079 - Safety and Effectiveness Assessment of PeGagen® (Pegfilgrastim) in the Prevention of Chemotherapy-induced FN
Recruiting NCT02725606 - Study to Assess the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GW003 in Patients With Breast Cancer Phase 1
Completed NCT02692742 - Efficacy and Safety Phase IIa Study of Myelo001 in Chemotherapy-Induced Neutropenia Phase 2
Completed NCT02532712 - Study to Evaluate the Safety, Tolerability and PK of EC-18 After Oral Administration in Healthy Volunteers Phase 1
Completed NCT01516736 - Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim Phase 3