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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

  • Clinicaltrials.gov identifier

    NCT03932864

  • Recruitment Status

    Completed

  • First Posted

    May 1, 2019

  • Last update posted

    February 26, 2021

Study Description

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:Healthy Volunteers
  • Intervention/Treatment: Biological: MGTA-145
    Biological: plerixafor
    Biological: Placebo
  • Phase: 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.

Study Design

  • Study Type: Interventional
  • Actual Enrollment: 107 participants
  • Allocation: Randomized
  • Intervention Model: Sequential Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • 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 2019
  • Actual Primary Completion Date: February 2020
  • Actual Study Completion Date: February 2020

Arms and interventions

Arm Intervention/treatment
Placebo Comparator: Single Ascending Dose of MGTA-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

Biological: Placebo
Placebo will be given in various doses intravenously
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
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

Outcome Measures

  • Primary Outcome Measures: 1. Safety as measured by incidence of treatment-emergent adverse events (AEs), serious adverse events (SAEs), and dose-limiting 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. Pharmacokinetics Biomarkers [ Time Frame: 15 days ]
    Investigate maximum plasma concentration (Cmax) of MGTA-145
  • 3. Pharmacokinetic Biomarkers [ Time Frame: 15 days ]
    Investigate clearance (CL) of MGTA-145
  • 4. Pharmacokinetic Biomarkers [ Time Frame: 15 days ]
    Investigate the volume of distribution at steady state (Vdss) of MGTA-145
  • 5. Pharmacokinetic Biomarkers [ Time Frame: 15 days ]
    Investigate the half-life of MGTA-145
  • 6. Pharmacodynamic Biomarkers [ Time Frame: 15 days ]
    Assess CD34+ cells per uL of blood by flow cytometry
  • 7. Pharmacodynamic Biomarkers [ Time Frame: 15 days ]
    Assess stem cell progenitors (colony forming units)

Eligibility Criteria

  • Ages Eligible for Study: 18 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

Contacts and Locations

Contacts

Locations

United States, Ohio
Medpace CPU
Cincinnati

Sponsors and Collaborators

Magenta Therapeutics, Inc.

More Information

  • 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: February 26, 2021
  • Last Verified: February 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No