NCT02245204

Phase I Studies of Chlorogenic Acid for Injection for Tolerance and Pharmacokinetic of Advanced Cancers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study: Determining the Maximum Tolerated Dose (MTD), Dose-Limiting Toxicity (DLT), pharmacokinetics characteristic, and dosage regimen of phase II/III of Chlorogenic acid for injection in the advanced malignant tumor subjects;

Detailed description

1. Investigate the tolerance of Chlorogenic acid for injection in human body, determine the Maximum Tolerated Dose (MTD) and Dose-Limiting Toxicity (DLT) of Chlorogenic acid for injection in the advanced malignant tumor subjects; 2. Determine the human pharmacokinetics characteristic of Chlorogenic acid for injection; 3. Preliminary observation the effectiveness and effective dose; 4. Provide the basis for the dosage regimen of phase II/III.

Conditions

• Advanced Cancer

Interventions

Type	Name	Description
DRUG	Chlorogenic acid	Chlorogenic acid for injection is polyphenols, micromolecular and un-endogenous substance. It might play the role of cancer treatment via balancing tumor micro-environmental immune status according to the stability and rationality of immunodeficiency and endogenous immune material expression around the tumor. Chlorogenic acid for injection is made from chlorogenic acid (purity≥98%) which is extracted from folium cortex eucommiae.Chlorogenic acid and its preparations have not been reported as chemical drug and marketed around the world.

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2014-09-19
• Last updated: 2018-11-21

Locations

1 site across 1 country: China