Healthy Adult VolunteersPhase 1NCT02942771
A MAD Study of TT301/MW189 in Healthy Volunteers
A Phase 1 study testing 0.075mg/kg TT301/MW189, 0.15mg/kg TT301MW189 and 0.25mg/kg TT301/MW189 in people with Healthy Adult Volunteers, run by Linda Van Eldik at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Volunteers
- What is being tested?
- 0.075mg/kg TT301/MW189, 0.15mg/kg TT301MW189 and 0.25mg/kg TT301/MW189
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2017to 4 Jun 2018
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Clinical Research Unit 40 Duke Medicine Circle
Durham, North Carolina, 27710
About this study
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
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.
Read the detailed description
This is a phase 1b study. Written informed consent will be obtained from each study participant before any study-specific procedures or assessments are done.
At various time points noted below, pharmacokinetic (PK) blood sampling will be performed on study participants.
Throughout the study the investigator will be assessing adverse events and concomitant medication.
On-Study/On-Interventions Evaluations/procedures: Participants will arrive at the Phase 1 unit after fasting a minimum of 10 hours, for admission into the unit and will undergo procedures:
- Medical and medication histories
- Infection screen
- Body temperature
- Vital signs (blood pressure and heart rate)
- Physical examination and weight
- Neurological exam
- Safety laboratory tests (blood and urine)
- Urine pregnancy test (females only)
- Alcohol screening (Breathalyzer)
- Urine drug screen
- Hepatitis B, C and HIV screening
- Randomize: Only participants who meet eligibility requirements will be randomized into the study.
Day 1 - Dosing: A light breakfast will be given prior to dosing. Participants will have the following tests/procedures performed at various time points during the day following confirmation of eligibility.
- 8 electrocardiograms (ECG)
- 8 vital signs (blood pressure and heart rate)
- 1 body temperature
- 12 PK Blood draws
- 2 study drug administrations
Day 2: A light breakfast will be given prior to dosing.
- 8 ECGs
- 8 vital signs (blood pressure and heart rate)
- 1 body temperature
- 1 PK blood draw
- 2 study Drug administration
Day 3: Participants will fast for a minimum of 10 hours. Water is allowed. A Light breakfast will be given before dosing
- 1 safety laboratory tests (blood and urine)
- 1 ECG
- 2 vital signs (blood pressure and heart rate)
- 1 body temperature
- 1 PK blood draw
- 1 neurological examination
- 2 study drug administrations
Day 4: A Light breakfast will be given before dosing
- 2 vital signs (blood Pressure and heart rate)
- 1 body temperature
- 1 PK blood draw
- 2 study drug administrations
Day 5: A Light breakfast will be given before dosing
- 1 ECG
- 2 vital signs (Blood Pressure and heart rate)
- 1 body temperature
- 12 PK blood draw
- 2 study drug administration
Day 6: Participants will fast for a minimum of 10 hours. Water is allowed. A Light breakfast will be given
- 1 safety laboratory test (blood and urine)
- 1 vital sign (Blood pressure and heart rate)
- 1 body temperature
- 1 neurological examination
- 2 PK blood draw
Day 7: A light breakfast will be provided
- 1 vital sign
- 1 body temperature
- 1 PK blood draw
Day 8 (Discharge): Participants will fast for a minimum of 10 hours. Water is allowed. A light breakfast will be offered
- 1 safety laboratory test (blood and urine)
- 1 ECG
- 1 vital sign (blood pressure and heart rate)
- 1 body temperature
- 1 physical examination including weight
- 1 neurological examination 2 Week Follow-up Visit: Participants will fast for a minimum of 10 hours. Water is allowed. during this visit participants will have the following tests and procedures performed:
- 1 safety laboratory test (blood and urine)
- 1 ECG
- 1 vital sign (blood pressure and heart rate)
- 1 body temperature
6-8 Week Follow-up Phone Call: Participants will be asked about any adverse events and any medications they may be taking.
- Conditions
- Healthy Adult Volunteers
- Being tested
- 0.075mg/kg TT301/MW189, 0.15mg/kg TT301MW189, 0.25mg/kg TT301/MW189, 0.30mg/kg TT301/MW189, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.075mg/kg TT301/MW189Drug
Also called TT301/MW189
0.075 mg/kg IV twice daily on Days 1 through 5
0.15mg/kg TT301MW189Drug
Also called TT301/MW189
0.15 mg/kg IV twice daily on Days 1 through 5
0.25mg/kg TT301/MW189Drug
Also called TT301/MW189
0.25 mg/kg IV twice daily on Days 1 through 5
0.30mg/kg TT301/MW189Drug
Also called TT301/MW189
0.30 mg/kg IV twice daily on Days 1 through 5
PlaceboDrug
0.9% sodium chloride
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - TT301/MW189 | Experimental | 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 Receives: Drug: 0.075mg/kg TT301/MW189 |
| Cohort 2 -TT301/MW189 | Experimental | 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 Receives: Drug: 0.15mg/kg TT301MW189 |
| Cohort 3- TT301/MW189 | Experimental | 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 Receives: Drug: 0.25mg/kg TT301/MW189 |
| Cohort 4- TT301/MW189 | Experimental | 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 Receives: Drug: 0.30mg/kg TT301/MW189 |
| Placebo | Placebo comparator | No drug intervention. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Events
The number of participants who experienced serious adverse events.
Measured: 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.
Measured: 4 weeks
Secondary outcomes (5)
Pharmacokinetics - Cmax
Maximum observed concentration in plasma.
Measured: 5 days
Pharmacokinetics - Tmax
Time to maximum concentration
Measured: 5 days
Pharmacokinetics - AUC
Area under the concentration-time curve
Measured: 5 days
Pharmacokinetics - T1/2
Terminal half-life (T1/2)
Measured: 5 days
Pharmacokinetics - Kel
Elimination rate constant
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study start20 Mar 2017
- Primary completion4 Jun 2018
- Study completion4 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Adult VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linda Van Eldik
- Sponsor type
- University, hospital or other
- Collaborators
- Duke Clinical Research Institute, Alzheimer's Association
- Responsible party
- Sponsor-investigator, Linda Van Eldik, University of Kentucky
- Investigators
- Linda J. Van Eldik, PhD, Study chair, University of KentuckyJeffrey T. Guptill, MD, MA,MHS, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942771
- Sponsor's protocol ID
- TT301/MW189 Phase 1b
- Status last verified
- Jun 2020
- First submitted
- 20 Oct 2016
- Last updated
- 16 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32255549
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02942771
- Acronym / sponsor ID
- TT301/MW189 Phase 1b
- Conditions
- Healthy Adult Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Linda Van EldikUniversity, hospital or other
- Collaborators
- Duke Clinical Research Institute, Alzheimer's Association
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 4 Jun 2018 (actual)
- Study completion
- 4 Jun 2018 (actual)
- First posted
- 24 Oct 2016 (estimated)
- Results
- Posted 2 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase 1b study. Written informed consent will be obtained from each study participant before any study-specific procedures or assessments are done.
At various time points noted below, pharmacokinetic (PK) blood sampling will be performed on study participants.
Throughout the study the investigator will be assessing adverse events and concomitant medication.
On-Study/On-Interventions Evaluations/procedures: Participants will arrive at the Phase 1 unit after fasting a minimum of 10 hours, for admission into the unit and will undergo procedures:
- Medical and medication histories
- Infection screen
- Body temperature
- Vital signs (blood pressure and heart rate)
- Physical examination and weight
- Neurological exam
- Safety laboratory tests (blood and urine)
- Urine pregnancy test (females only)
- Alcohol screening (Breathalyzer)
- Urine drug screen
- Hepatitis B, C and HIV screening
- Randomize: Only participants who meet eligibility requirements will be randomized into the study.
Day 1 - Dosing: A light breakfast will be given prior to dosing. Participants will have the following tests/procedures performed at various time points during the day following confirmation of eligibility.
- 8 electrocardiograms (ECG)
- 8 vital signs (blood pressure and heart rate)
- 1 body temperature
- 12 PK Blood draws
- 2 study drug administrations
Day 2: A light breakfast will be given prior to dosing.
- 8 ECGs
- 8 vital signs (blood pressure and heart rate)
- 1 body temperature
- 1 PK blood draw
- 2 study Drug administration
Day 3: Participants will fast for a minimum of 10 hours. Water is allowed. A Light breakfast will be given before dosing
- 1 safety laboratory tests (blood and urine)
- 1 ECG
- 2 vital signs (blood pressure and heart rate)
- 1 body temperature
- 1 PK blood draw
- 1 neurological examination
- 2 study drug administrations
Day 4: A Light breakfast will be given before dosing
- 2 vital signs (blood Pressure and heart rate)
- 1 body temperature
- 1 PK blood draw
- 2 study drug administrations
Day 5: A Light breakfast will be given before dosing
- 1 ECG
- 2 vital signs (Blood Pressure and heart rate)
- 1 body temperature
- 12 PK blood draw
- 2 study drug administration
Day 6: Participants will fast for a minimum of 10 hours. Water is allowed. A Light breakfast will be given
- 1 safety laboratory test (blood and urine)
- 1 vital sign (Blood pressure and heart rate)
- 1 body temperature
- 1 neurological examination
- 2 PK blood draw
Day 7: A light breakfast will be provided
- 1 vital sign
- 1 body temperature
- 1 PK blood draw
Day 8 (Discharge): Participants will fast for a minimum of 10 hours. Water is allowed. A light breakfast will be offered
- 1 safety laboratory test (blood and urine)
- 1 ECG
- 1 vital sign (blood pressure and heart rate)
- 1 body temperature
- 1 physical examination including weight
- 1 neurological examination 2 Week Follow-up Visit: Participants will fast for a minimum of 10 hours. Water is allowed. during this visit participants will have the following tests and procedures performed:
- 1 safety laboratory test (blood and urine)
- 1 ECG
- 1 vital sign (blood pressure and heart rate)
- 1 body temperature
6-8 Week Follow-up Phone Call: Participants will be asked about any adverse events and any medications they may be taking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - TT301/MW189 | Experimental | Drug: 0.075mg/kg TT301/MW189TT301/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 | Experimental | Drug: 0.15mg/kg TT301MW189TT301/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 | Experimental | Drug: 0.25mg/kg TT301/MW189TT301/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 | Experimental | Drug: 0.30mg/kg TT301/MW189TT301/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 comparator | Drug: PlaceboNo drug intervention. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.075mg/kg TT301/MW189Also: TT301/MW1890.075 mg/kg IV twice daily on Days 1 through 5 | Drug | Cohort 1 - TT301/MW189 |
| 0.15mg/kg TT301MW189Also: TT301/MW1890.15 mg/kg IV twice daily on Days 1 through 5 | Drug | Cohort 2 -TT301/MW189 |
| 0.25mg/kg TT301/MW189Also: TT301/MW1890.25 mg/kg IV twice daily on Days 1 through 5 | Drug | Cohort 3- TT301/MW189 |
| 0.30mg/kg TT301/MW189Also: TT301/MW1890.30 mg/kg IV twice daily on Days 1 through 5 | Drug | Cohort 4- TT301/MW189 |
| Placebo0.9% sodium chloride | Drug | Placebo |
Primary outcome
Serious Adverse Events
Time frame: 4 weeks
The number of participants who experienced serious adverse events.
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.
5 secondary outcomes
Pharmacokinetics - Cmax
Time frame: 5 days
Pharmacokinetics - Tmax
Time frame: 5 days
Pharmacokinetics - AUC
Time frame: 5 days
Pharmacokinetics - T1/2
Time frame: 5 days
Pharmacokinetics - Kel
Time frame: 5 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32255549Van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda J. Van Eldik, PhD study chair
University of Kentucky
Jeffrey T. Guptill, MD, MA,MHS principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 0.075mg/kg TT301/MW189, 0.15mg/kg TT301MW189 and 0.25mg/kg TT301/MW189 in people with Healthy Adult Volunteers, run by Linda Van Eldik at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Adverse Events (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02942771, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.