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First in Man Evaluation of Single and Multiple Doses of Oral ATX2417

NCT02316912 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2016-07-19

No results posted yet for this study

Summary

First in man evaluation of single and multiple doses of compound ATX2417 in healthy male volunteers. A double blind placebo controlled parallel group ascending dose design; up to five dose levels for the single dose and up to two dose levels for the multiple dose (8 days of dosing). Subjects will be screened to assure normal health prior to inclusion in the trial and will be monitored for safety (adverse events, vital signs, ECGs, safety labs) and pharmacokinetic profile. A fasted/fed comparison will also be included in the single ascending dose part of the trial.

Conditions

  • Allergy

Interventions

DRUG

ATX2417

Randomised double blind parallel group ascending dose assessment

DRUG

Placebo

Randomised double blind parallel group ascending dose assessment

Sponsors & Collaborators

  • Simbec Research

    collaborator INDUSTRY

  • Atopix Therapeutics, Ltd.

    lead INDUSTRY

Principal Investigators

  • Khalid Abou Farha, MD · Simbec Research

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United Kingdom

Study Locations

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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 NCT02316912 on ClinicalTrials.gov