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Multiple Ascending Dose to Study the Safety, Tolerability, PK and PD Effects of AEF0117

NCT03443895 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-06-19

No results posted yet for this study

Summary

The study is designated to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of escalating multiple oral doses of AEF0117 in healthy adult male and female subjects.

Conditions

  • Healthy Volunteers

Interventions

DRUG

AEF0117 oral capsule

0.6, 2 and 6mg of AEF0117

DRUG

Placebo oral capsule

Matching placebo capsule

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Aelis Farma

    lead INDUSTRY

Principal Investigators

  • Michael Dobrow, MD · Biotrial Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2018-01-08
Primary Completion
2018-05-01
Completion
2018-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03443895 on ClinicalTrials.gov