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

NCT03430999 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2018-02-13

No results posted yet for this study

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

DRUG

Calmangafodipir

Single ascending doses of 2 μmol/kg, 5 μmol/kg, and 10 μmol/kg

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Egetis Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-07
Primary Completion
2017-12-18
Completion
2017-12-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03430999 on ClinicalTrials.gov