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

Sponsor

Magenta Therapeutics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03932864

Collaborator

(none)

107

Enrollment

Location

Arms

10.2

Actual Duration (Months)

10.5

Patients Per Site Per Month

Study Details

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	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.

Study Design

Study Type:

Interventional

Actual Enrollment :

107 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 :

Apr 22, 2019

Actual Primary Completion Date :

Feb 25, 2020

Actual Study Completion Date :

Feb 25, 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 Other Names: 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 Names: 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 Names: Mozobil

Outcome Measures

Primary Outcome Measures

Safety as measured by incidence of treatment-emergent adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs). [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

Pharmacokinetics Biomarkers [15 days]
Investigate area under the curve (AUC) of MGTA-145
Pharmacokinetics Biomarkers [15 days]
Investigate maximum plasma concentration (Cmax) of MGTA-145
Pharmacokinetic Biomarkers [15 days]
Investigate clearance (CL) of MGTA-145
Pharmacokinetic Biomarkers [15 days]
Investigate the volume of distribution at steady state (Vdss) of MGTA-145
Pharmacokinetic Biomarkers [15 days]
Investigate the half-life of MGTA-145
Pharmacodynamic Biomarkers [15 days]
Assess CD34+ cells per uL of blood by flow cytometry
Pharmacodynamic Biomarkers [15 days]
Assess stem cell progenitors (colony forming units)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age from 18 to 60 years
Body weight ≥50 kg and body mass index 19 to 33 kg/m2
No clinically significant abnormalities on physical examination at Screening
Non-smoker for at least 2 years
No clinically significant lab abnormalities for renal, hepatic or hematologic parameters
No clinically significant abnormalities on ECG
Female subjects must be of non-childbearing potential
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
No contraindications for apheresis

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medpace CPU	Cincinnati	Ohio	United States	45227

Sponsors and Collaborators

Magenta Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Magenta Therapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT03932864

Other Study ID Numbers:

145-HV-101

First Posted:

May 1, 2019

Last Update Posted:

Feb 26, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Plerixafor

Study Results

No Results Posted as of Feb 26, 2021