Phase 1
Completed N=35
A MAD Study of TT301/MW189 in Healthy Volunteers
Healthy Adult Volunteers
Source: ClinicalTrials.gov NCT02942771 ↗
Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Serious Adverse Events — 0; 0; 0; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serious Adverse Events |
0; 0; 0; 0; 0 | — |
| PRIMARY Treatment-Emergent Adverse Events |
5; 6; 4; 6; 6 | — |
| SECONDARY Pharmacokinetics - Cmax |
227; 347; 609; 750 | — |
| SECONDARY Pharmacokinetics - Tmax |
— | — |
| SECONDARY Pharmacokinetics - AUC |
362; 639; 1225; 1525 | — |
| SECONDARY Pharmacokinetics - T1/2 |
8.5; 8.5; 8.8; 9.1 | — |
| SECONDARY Pharmacokinetics - Kel |
0.090; 0.093; 0.085; 0.081 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02942771). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.