NCT03430999

SUNCIST: A Study of Calmangafodipir in Healthy Japanese and Caucasian Subjects

SUNCIST: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Ascending, Single-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics of Intravenous Administration of Calmangafodipir in Healthy Japanese and Caucasian Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Egetis Therapeutics · Industry
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Randomized, double-bline, placebo-controlled, single dose study comparing the pharmacokinetics (PK) and safety of PP095-01 in Japanese and non-Asian (eg, Caucasian) subjects.

Conditions

• Chemotherapy Induced Peripheral Neuropathy (CIPN)

Interventions

Type	Name	Description
DRUG	Calmangafodipir	Single ascending doses of 2 μmol/kg, 5 μmol/kg, and 10 μmol/kg
DRUG	Placebo	Placebo

Timeline

• Start date: 2017-11-07
• Primary completion: 2017-12-18
• Completion: 2017-12-18
• First posted: 2018-02-13
• Last updated: 2018-02-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study