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Study Assessing Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MGTA-145 in Healthy Volunteers as a Single Agent or in Combination With Plerixafor

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ClinicalTrials.gov Identifier: NCT03932864
Recruitment Status : Recruiting
First Posted : May 1, 2019
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Magenta Therapeutics, Inc.

Brief Summary:
To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MGTA-145 in healthy volunteers as a single agent and in combination with plerixafor.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Biological: MGTA-145 Biological: plerixafor Biological: Placebo Phase 1

Detailed Description:
The study consists of up to four parts: Part A, to investigate the safety and tolerability of MGTA-145; Part B, to investigate the safety and tolerability of MGTA-145 when administered in combination with plerixafor; Part C, to investigate the safety and tolerability of two sequential days of dosing MGTA-145 in combination with plerixafor; and Part D, to investigate the safety, tolerability, and measure by apheresis, the total number of CD34+ cells mobilized after a dose of MGTA-145 administered in combination with plerixafor.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double Blind
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Ascending Dose Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Parameters of MGTA-145 in Healthy Subjects Administered as a Single Agent, as Well as in Combination With Plerixafor
Actual Study Start Date : April 22, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Plerixafor

Arm Intervention/treatment
Placebo Comparator: Single Ascending Dose of MTGA-145 or placebo
MGTA-145 or placebo dose escalation as single agent, single dose
Biological: MGTA-145
MGTA-145 will be given in various doses intravenously

Biological: Placebo
Placebo will be given in various doses intravenously

Placebo Comparator: Single Dose MGTA-145 or placebo plus plerixafor
MGTA-145 or placebo in combination with plerixafor, single dose
Biological: MGTA-145
MGTA-145 will be given in various doses intravenously

Biological: plerixafor
240 µg/kg subcutaneously
Other Name: Mozobil

Biological: Placebo
Placebo will be given in various doses intravenously

Experimental: Single dose MGTA-145 plus plerixafor for 2 sequential d
MGTA-145 in combination with plerixafor on two consecutive days; single dose per day
Biological: MGTA-145
MGTA-145 will be given in various doses intravenously

Biological: plerixafor
240 µg/kg subcutaneously
Other Name: Mozobil

Experimental: Single dose MGTA-145 plus plerixafor followed by apheresis
MGTA-145 in combination with plerixafor followed by apheresis
Biological: MGTA-145
MGTA-145 will be given in various doses intravenously

Biological: plerixafor
240 µg/kg subcutaneously
Other Name: Mozobil




Primary Outcome Measures :
  1. Safety as measured by incidence of treatment-emergent adverse events (AEs), serious adverse events (SAEs), and doselimiting toxicities (DLTs). [ Time Frame: 28 days ]
    Investigate the safety and tolerability of MGTA-145 following intravenous (IV) administration as monotherapy or in combination with plerixafor in healthy subjects (e.g. adverse events, clinical laboratory tests, vital signs, ECGs)


Secondary Outcome Measures :
  1. Pharmacokinetics Biomarkers [ Time Frame: 15 days ]
    Investigate area under the curve (AUC) of MGTA-145

  2. Pharmacokinetic Biomarkers [ Time Frame: 15 days ]
    Investigate area under the curve (AUC) of MGTA-145

  3. Pharmacokinetics Biomarkers [ Time Frame: 15 days ]
    Investigate maximum plasma concentration (Cmax) of MGTA-145

  4. Pharmacokinetic Biomarkers [ Time Frame: 15 days ]
    Investigate clearance (CL) of MGTA-145

  5. Pharmacokinetic Biomarkers [ Time Frame: 15 days ]
    Investigate maximum plasma concentration (Cmax) of MGTS-145

  6. Pharmacokinetic Biomarkers [ Time Frame: 15 days ]
    Investiagte the volume of distribution at steady state (Vdss) of MGTA-145

  7. Pharmacokinetic Biomarkers [ Time Frame: 15 days ]
    Investigate the half-life of MGTA-145

  8. Pharmacodynamic Biomarkers [ Time Frame: 15 days ]
    Assess CD34+ cells per uL of blood by flow cytometry

  9. Pharmacodynamic Biomarkers [ Time Frame: 15 days ]
    Assess stem cell progenitors (colony forming units)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age from 18 to 60 years
  2. Body weight ≥50 kg and body mass index 19 to 33 kg/m2
  3. No clinically significant abnormalities on physical examination at Screening
  4. Non-smoker for at least 2 years
  5. No clinically significant lab abnormalities for renal, hepatic or hematologic parameters
  6. No clinically significant abnormalities on ECG
  7. Female subjects must be of non-childbearing potential
  8. Male subjects who are sexually abstinent or surgically sterilized (vasectomy), or those who are sexually active with a female partner(s) and agree to use an acceptable method of contraception
  9. No contraindications for apheresis

Exclusion Criteria:

  1. Any clinically significant laboratory value outside the normal range at screening
  2. Donation of more than 500 mL of blood or plasma within 12 weeks prior to dosing
  3. History of alcoholism or drug abuse within the past 3 years
  4. Subject has used any prescription drugs within 14 days prior to dosing or any dietary supplements or non-prescription drugs within 7 days prior to dosing
  5. Acute illness, infection (requiring medical treatment [eg, antibiotics]), or surgery within 4 weeks of dosing
  6. Seropositive for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus
  7. Subject has received another investigational drug or participated in an investigational drug or device study within 12 weeks prior to dosing
  8. History of anaphylaxis or clinically important reaction to any drug including plerixafor
  9. Any clinically significant hematologic, cardiovascular, pulmonary, central nervous system, metabolic, renal, hepatic, or gastrointestinal conditions

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): NCT03932864


Contacts
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Contact: Magenta Clinical Trials 857-242-0170 clinicaltrials@magentatx.com

Locations
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United States, Ohio
Medpace CPU Recruiting
Cincinnati, Ohio, United States, 45227
Contact: Dismas Meyers    513-366-3220 ext 12767    d.meyers@medpace.com   
Principal Investigator: Lukasz Biernat, MD         
Sponsors and Collaborators
Magenta Therapeutics, Inc.

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Responsible Party: Magenta Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03932864     History of Changes
Other Study ID Numbers: 145-HV-101
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Plerixafor octahydrochloride
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents