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Study to Assess Pharmacokinetics, Safety, and Tolerability of XC-8

NCT02882217 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2017-05-18

No results posted yet for this study

Summary

The study focusses on the evaluation of safety and tolerability of the XC8. The design of the study involves sequential dosing of cohorts (group of volunteers), taking increasing doses of the product after receiving conclusion and recommendation for further continuation of the study from the Dose Escalation Committee.

Conditions

Interventions

DRUG

XC8 (histamine glutarimide)

DRUG

Placebo

Sponsors & Collaborators

  • EURRUS Biotech GmbH

    lead INDUSTRY

Principal Investigators

  • Helmut Schmutz, Mag.iur. · EURRUS Biotech GmbH

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • Austria
  • Germany

Study Locations

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Entities

Drugs
Diseases

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 NCT02882217 on ClinicalTrials.gov