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A MAD Study of TT301/MW189 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02942771
Recruitment Status : Completed
First Posted : October 24, 2016
Results First Posted : June 2, 2020
Last Update Posted : June 16, 2020
Sponsor:
Collaborators:
Duke Clinical Research Institute
Alzheimer's Association
Information provided by (Responsible Party):
Linda Van Eldik, University of Kentucky

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Adult Volunteers Drug: 0.075mg/kg TT301/MW189 Drug: 0.15mg/kg TT301MW189 Drug: 0.25mg/kg TT301/MW189 Drug: 0.30mg/kg TT301/MW189 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1b, Double-Blind, Randomized, Placebo-Controlled Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TT301/MW189 Administered Intravenously to Healthy Volunteers
Actual Study Start Date : March 20, 2017
Actual Primary Completion Date : June 4, 2018
Actual Study Completion Date : June 4, 2018

Arm Intervention/treatment
Experimental: Cohort 1 - TT301/MW189
TT301/MW189 0.075 mg/kg IV (or matched placebo). Each subject will receive 1 dose level of study drug twice daily (bid) on Days 1 through 5, inclusive
Drug: 0.075mg/kg TT301/MW189
0.075 mg/kg IV twice daily on Days 1 through 5
Other Name: TT301/MW189

Experimental: Cohort 2 -TT301/MW189
TT301/MW189 0.15 mg/kg IV (or matched placebo). Each subject will receive 1 dose level of study drug twice daily (bid) on Days 1 through 5, inclusive
Drug: 0.15mg/kg TT301MW189
0.15 mg/kg IV twice daily on Days 1 through 5
Other Name: TT301/MW189

Experimental: Cohort 3- TT301/MW189
TT301/MW189 0.25 mg/kg IV (or matched placebo). Each subject will receive 1 dose level of study drug twice daily (bid) on Days 1 through 5, inclusive
Drug: 0.25mg/kg TT301/MW189
0.25 mg/kg IV twice daily on Days 1 through 5
Other Name: TT301/MW189

Experimental: Cohort 4- TT301/MW189
TT301/MW189 0.30 mg/kg IV (or matched placebo). Each subject will receive 1 dose level of study drug twice daily (bid) on Days 1 through 5, inclusive
Drug: 0.30mg/kg TT301/MW189
0.30 mg/kg IV twice daily on Days 1 through 5
Other Name: TT301/MW189

Placebo Comparator: Placebo
No drug intervention.
Drug: Placebo
0.9% sodium chloride




Primary Outcome Measures :
  1. Serious Adverse Events [ Time Frame: 4 weeks ]
    The number of participants who experienced serious adverse events.

  2. Treatment-Emergent Adverse Events [ Time Frame: 4 weeks ]
    The number of participants who experienced treatment-emergent adverse events (TEAEs). A TEAE is defined as an adverse event that started during the treatment period.


Secondary Outcome Measures :
  1. Pharmacokinetics - Cmax [ Time Frame: 5 days ]
    Maximum observed concentration in plasma.

  2. Pharmacokinetics - Tmax [ Time Frame: 5 days ]
    Time to maximum concentration

  3. Pharmacokinetics - AUC [ Time Frame: 5 days ]
    Area under the concentration-time curve

  4. Pharmacokinetics - T1/2 [ Time Frame: 5 days ]
    Terminal half-life (T1/2)

  5. Pharmacokinetics - Kel [ Time Frame: 5 days ]
    Elimination rate constant



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Willingness and capacity to give informed consent
  • Is in good health
  • Weights 50.0 - 120.0 kg
  • Not pregnant
  • Must agree to use birth control for 1 week after the last day of study drug administration
  • Willingness to comply with protocol requirements, including fasting, alcohol and nicotine restrictions, during the study and is available to complete the study
  • Adequate forearm vein access
  • No significant dietary restrictions
  • Must not have donated blood, platelets, or any other blood components 30 days, or plasma 60 days, prior to consenting. Must also agree not to donate blood, platelets, or any other blood components for 8 weeks after the last dose of study drug

Exclusion Criteria:

  • Lactating or is pregnant
  • severe ischemic heart disease or congestive heart failure
  • Heart attack within the previous 2 years;
  • history of stroke or cardiomyopathy;
  • significant liver or kidney disease;
  • diabetes;
  • history of any autoimmune disorder; or a history of chronic infections
  • a history of cancer
  • has received antibiotic treatment or has undergone a surgical procedure within 30 days of Day 1
  • has a history of Hepatitis C, Hepatitis B or tuberculosis (TB)
  • has a history of Human Immunodeficiency Virus (HIV)
  • a history of alcohol or drug use within the twelve months prior to study drug administration
  • has used any immunosuppressants or chronic anti-inflammatory drugs medication including prescription medication, over-the-counter medication, health/herbal supplement or vitamin by any route of administration within 7 days of Day 1
  • has donated blood within 30 days of consenting or has donated plasma within 60 days of consenting
  • has participated in a clinical trial of an immunosuppressive drug within 6 months of Day 1
  • has received an investigational drug, used an investigational device or received an investigational medical procedure within 60 days of Day 1, or concurrent with participation in this study
  • has participated in any observational studies, experimental studies of non-investigational drugs, devices, or medical procedures within 30 days of Day 1, or concurrent with participation in this study
  • has participated in a previous trial with TT301/MW189
  • has a history of unexplained syncope or fainting from the collection of blood; i.e., autonomic dysfunction.
  • Lack of ability to understand verbal and/ or written English
  • had significant trauma or surgical procedure within 1 month prior to Screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02942771


Locations
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United States, North Carolina
Duke Clinical Research Unit 40 Duke Medicine Circle
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Linda Van Eldik
Duke Clinical Research Institute
Alzheimer's Association
Investigators
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Study Chair: Linda J. Van Eldik, PhD University of Kentucky
Principal Investigator: Jeffrey T. Guptill, MD, MA,MHS Duke University
  Study Documents (Full-Text)

Documents provided by Linda Van Eldik, University of Kentucky:
Publications of Results:
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Responsible Party: Linda Van Eldik, Sponsor, University of Kentucky
ClinicalTrials.gov Identifier: NCT02942771    
Other Study ID Numbers: TT301/MW189 Phase 1b
First Posted: October 24, 2016    Key Record Dates
Results First Posted: June 2, 2020
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No