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A MAD Study of TT301/MW189 in Healthy Volunteers

NCT02942771 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2020-06-16

Study results available
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Summary

The purpose of this Study is to find out whether an investigational drug is safe and well tolerated. MW189 is being studied as a possible short-term treatment for people with different types of brain injury. MW189 has previously been given to healthy human volunteers as a single dose, and there were no significant problems or bad effects in people who received the Study drug. However, before it can be tested in people with brain injury, it is important to test MW189 in healthy volunteers when given multiple doses.

Conditions

  • Healthy Adult Volunteers

Interventions

DRUG

0.075mg/kg TT301/MW189

0.075 mg/kg IV twice daily on Days 1 through 5

DRUG

0.15mg/kg TT301MW189

0.15 mg/kg IV twice daily on Days 1 through 5

DRUG

0.25mg/kg TT301/MW189

0.25 mg/kg IV twice daily on Days 1 through 5

DRUG

0.30mg/kg TT301/MW189

0.30 mg/kg IV twice daily on Days 1 through 5

DRUG

Placebo

0.9% sodium chloride

Sponsors & Collaborators

  • Duke Clinical Research Institute

    collaborator OTHER

  • Alzheimer's Association

    collaborator OTHER

  • Linda Van Eldik

    lead OTHER

Principal Investigators

  • Linda J. Van Eldik, PhD · University of Kentucky

  • Jeffrey T. Guptill, MD, MA,MHS · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-03-20
Primary Completion
2018-06-04
Completion
2018-06-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT02942771 on ClinicalTrials.gov