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ACH04 to Assess the Safety and Tolerability in Healthy Adults Subjects

NCT02949089 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-10-31

No results posted yet for this study

Summary

This study intends to provide information on the safety and tolerability of repeated oral doses of ACH04. A phase I, single-center, first in human, open-label, dose escalation study of ACH04 to assess the safety and tolerability in healthy adults subjects is selected to best address the study goals.

Conditions

Interventions

DRUG

ACH04

The subjects will receive the study medication in each group

Sponsors & Collaborators

  • Ache Laboratorios Farmaceuticos S.A.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • Brazil

Study Locations

More Related Trials

Entities

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 NCT02949089 on ClinicalTrials.gov