A MAD Study of TT301/MW189 in Healthy Volunteers
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
1 other identifier
interventional
35
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2016
CompletedFirst Posted
Study publicly available on registry
October 24, 2016
CompletedStudy Start
First participant enrolled
March 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 4, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 4, 2018
CompletedResults Posted
Study results publicly available
June 2, 2020
CompletedJune 16, 2020
June 1, 2020
1.2 years
October 20, 2016
May 15, 2020
June 2, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Serious Adverse Events
The number of participants who experienced serious adverse events.
4 weeks
Treatment-Emergent Adverse Events
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.
4 weeks
Secondary Outcomes (5)
Pharmacokinetics - Cmax
5 days
Pharmacokinetics - Tmax
5 days
Pharmacokinetics - AUC
5 days
Pharmacokinetics - T1/2
5 days
Pharmacokinetics - Kel
5 days
Study Arms (5)
Cohort 1 - TT301/MW189
EXPERIMENTALTT301/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
Cohort 2 -TT301/MW189
EXPERIMENTALTT301/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
Cohort 3- TT301/MW189
EXPERIMENTALTT301/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
Cohort 4- TT301/MW189
EXPERIMENTALTT301/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
Placebo
PLACEBO COMPARATORNo drug intervention.
Interventions
0.075 mg/kg IV twice daily on Days 1 through 5
0.15 mg/kg IV twice daily on Days 1 through 5
0.25 mg/kg IV twice daily on Days 1 through 5
0.30 mg/kg IV twice daily on Days 1 through 5
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Linda Van Eldiklead
- Duke Clinical Research Institutecollaborator
- Alzheimer's Associationcollaborator
Study Sites (1)
Duke Clinical Research Unit 40 Duke Medicine Circle
Durham, North Carolina, 27710, United States
Related Publications (1)
Van Eldik LJ, Sawaki L, Bowen K, Laskowitz DT, Noveck RJ, Hauser B, Jordan L, Spears TG, Wu H, Watt K, Raja S, Roy SM, Watterson DM, Guptill JT. First-in-Human Studies of MW01-6-189WH, a Brain-Penetrant, Antineuroinflammatory Small-Molecule Drug Candidate: Phase 1 Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Studies in Healthy Adult Volunteers. Clin Pharmacol Drug Dev. 2021 Feb;10(2):131-143. doi: 10.1002/cpdd.795. Epub 2020 Apr 7.
PMID: 32255549RESULT
MeSH Terms
Interventions
Results Point of Contact
- Title
- Dr. Linda Van Eldik
- Organization
- University of Kentucky
Study Officials
- STUDY CHAIR
Linda J. Van Eldik, PhD
University of Kentucky
- PRINCIPAL INVESTIGATOR
Jeffrey T. Guptill, MD, MA,MHS
Duke University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Sponsor
Study Record Dates
First Submitted
October 20, 2016
First Posted
October 24, 2016
Study Start
March 20, 2017
Primary Completion
June 4, 2018
Study Completion
June 4, 2018
Last Updated
June 16, 2020
Results First Posted
June 2, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share