Clinical Trials Logo
  1. Home
  2. Chemotherapy-Induced Neutropenia
  3. NCT02532712

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

Chemotherapy-Induced Neutropenia Clinical Trial

Official title:
A Dose Block-randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Escalation, Phase I Clinical Trial to Evaluate the Safety, Tolerability and PK of EC-18 After Oral Administration in Healthy Male Volunteers

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02532712
Study type Interventional
Source Enzychem Lifesciences Corporation
Contact
Status Completed
Phase Phase 1
Start date March 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
Terminated NCT02454530 - Use of Biosimilar Nivestim® to Prevent Chemo-induced Neutropenia. Real Life Study
Completed NCT02251977 - Effect of GM1 in Prevention of Oxaliplatin Induced Neurotoxicity in Stage II/III Colorectal Cancer Phase 3
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 NCT01516736 - Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim Phase 3
Terminated NCT04887831 - Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab Phase 2