NCT02693093

A Dose Ranging Study Evaluating Efficacy and Safety of NI-03

A Phase 1, Single Dose PK and Safety Study With NI-03 Followed by a Phase 2, Randomized, Double-Blind, Parallel-Group Dose-Ranging Study to Evaluate the Safety and Efficacy of NI-03 When Compared to Placebo in Subjects With Chronic Pancreatitis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 264 (actual)
• Sponsor: Kangen Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and efficacy of NI-03.

Detailed description

The primary objective of the Single-Dose Phase is to assess the pharmacokinetics (PK) and safety of single doses of NI-03 when administered at doses of 100 mg, 200 mg or 300 mg to subjects with chronic pancreatitis. The primary objective of the Double-Blind Phase of the study is to determine the efficacy, PK and safety of three doses of NI-03 (100 mg, 200 mg and 300 mg) as compared to placebo when administered three times daily (TID) for 28 consecutive days in subjects with chronic pancreatitis.

Conditions

• Chronic Pancreatitis

Interventions

Type	Name	Description
DRUG	NI-03
DRUG	Placebo

Timeline

• Start date: 2016-02-24
• Primary completion: 2021-09-30
• Completion: 2021-12-30
• First posted: 2016-02-26
• Last updated: 2022-12-16

Locations

48 sites across 3 countries: United States, Russia, Ukraine