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A MAD Study of TT301/MW189 in Healthy Volunteers

2. juni 2020 opdateret af: Linda Van Eldik

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

35

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke Clinical Research Unit 40 Duke Medicine Circle

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 50 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Medicin: 0.075mg/kg TT301/MW189
0.075 mg/kg IV twice daily on Days 1 through 5
Andre navne:
  • TT301/MW189
Eksperimentel: 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
Medicin: 0.15mg/kg TT301MW189
0.15 mg/kg IV twice daily on Days 1 through 5
Andre navne:
  • TT301/MW189
Eksperimentel: 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
Medicin: 0.25mg/kg TT301/MW189
0.25 mg/kg IV twice daily on Days 1 through 5
Andre navne:
  • TT301/MW189
Eksperimentel: 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
Medicin: 0.30mg/kg TT301/MW189
0.30 mg/kg IV twice daily on Days 1 through 5
Andre navne:
  • TT301/MW189
Placebo komparator: Placebo
No drug intervention.
Medicin: Placebo
0,9% natriumchlorid

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Serious Adverse Events
Tidsramme: 4 weeks
The number of participants who experienced serious adverse events.
4 weeks
Treatment-Emergent Adverse Events
Tidsramme: 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.
4 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pharmacokinetics - Cmax
Tidsramme: 5 days
Maximum observed concentration in plasma.
5 days
Pharmacokinetics - Tmax
Tidsramme: 5 days
Time to maximum concentration
5 days
Pharmacokinetics - AUC
Tidsramme: 5 days
Area under the concentration-time curve
5 days
Pharmacokinetics - T1/2
Tidsramme: 5 days
Terminal half-life (T1/2)
5 days
Pharmacokinetics - Kel
Tidsramme: 5 days
Elimination rate constant
5 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Linda Van Eldik

Samarbejdspartnere

Duke Clinical Research Institute
Alzheimer's Association

Efterforskere

  • Studiestol: Linda J. Van Eldik, PhD, University of Kentucky
  • Ledende efterforsker: Jeffrey T. Guptill, MD, MA,MHS, Duke University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. marts 2017

Primær færdiggørelse (Faktiske)

4. juni 2018

Studieafslutning (Faktiske)

4. juni 2018

Datoer for studieregistrering

Først indsendt

20. oktober 2016

Først indsendt, der opfyldte QC-kriterier

21. oktober 2016

Først opslået (Skøn)

24. oktober 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2020

Sidst verificeret

1. juni 2020

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • TT301/MW189 Phase 1b

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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