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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.

Tracking Information
First Submitted Date  ICMJE April 22, 2019
First Posted Date  ICMJE May 1, 2019
Last Update Posted Date May 1, 2019
Actual Study Start Date  ICMJE April 22, 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2019)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2019)
  • Pharmacokinetics Biomarkers [ Time Frame: 15 days ]
    Investigate area under the curve (AUC) of MGTA-145
  • Pharmacokinetic Biomarkers [ Time Frame: 15 days ]
    Investigate area under the curve (AUC) of MGTA-145
  • Pharmacokinetics Biomarkers [ Time Frame: 15 days ]
    Investigate maximum plasma concentration (Cmax) of MGTA-145
  • Pharmacokinetic Biomarkers [ Time Frame: 15 days ]
    Investigate clearance (CL) of MGTA-145
  • Pharmacokinetic Biomarkers [ Time Frame: 15 days ]
    Investigate maximum plasma concentration (Cmax) of MGTS-145
  • Pharmacokinetic Biomarkers [ Time Frame: 15 days ]
    Investiagte the volume of distribution at steady state (Vdss) of MGTA-145
  • Pharmacokinetic Biomarkers [ Time Frame: 15 days ]
    Investigate the half-life of MGTA-145
  • Pharmacodynamic Biomarkers [ Time Frame: 15 days ]
    Assess CD34+ cells per uL of blood by flow cytometry
  • Pharmacodynamic Biomarkers [ Time Frame: 15 days ]
    Assess stem cell progenitors (colony forming units)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Assessing Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MGTA-145 in Healthy Volunteers as a Single Agent or in Combination With Plerixafor
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double Blind
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Single Ascending Dose of MTGA-145 or placebo
    MGTA-145 or placebo dose escalation as single agent, single dose
    Interventions:
    • Biological: MGTA-145
    • Biological: Placebo
  • Placebo Comparator: Single Dose MGTA-145 or placebo plus plerixafor
    MGTA-145 or placebo in combination with plerixafor, single dose
    Interventions:
    • Biological: MGTA-145
    • Biological: plerixafor
    • Biological: Placebo
  • 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
    Interventions:
    • Biological: MGTA-145
    • Biological: plerixafor
  • Experimental: Single dose MGTA-145 plus plerixafor followed by apheresis
    MGTA-145 in combination with plerixafor followed by apheresis
    Interventions:
    • Biological: MGTA-145
    • Biological: plerixafor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 27, 2019)
72
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Magenta Clinical Trials 857-242-0170 clinicaltrials@magentatx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03932864
Other Study ID Numbers  ICMJE 145-HV-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Magenta Therapeutics, Inc.
Study Sponsor  ICMJE Magenta Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Magenta Therapeutics, Inc.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP