CompletedNCT03932864Updated Jan 11, 2024

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

A Phase 1 interventional study of MGTA-145 and plerixafor in Healthy Volunteers, sponsored by Ensoma. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-11.

Sponsored by Ensoma · Phase 1, Interventional, and Treatment

From the registry’s dates

Primary completion was Feb 2020, 6 years 7 months ago, and no results have been posted to the registry.

Phase: Phase 1
Study type: Interventional
Enrollment: 107
Allocation: Randomized
Ages: 18 Years to 60 Years
Sex: All

Study summary

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

Read the 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.

Conditions studied

Healthy Volunteers

In context

Lead sponsor

Ensoma is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: 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

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

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 107 participants (actual)

Study arms

Placebo comparator
Single Ascending Dose of MGTA-145 or placebo
MGTA-145 or placebo dose escalation as single agent, single dose
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
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
Biological: MGTA-145 · Biological: plerixafor
Experimental
Single dose MGTA-145 plus plerixafor followed by apheresis
MGTA-145 in combination with plerixafor followed by apheresis
Biological: MGTA-145 · Biological: plerixafor

Interventions

BiologicalMGTA-145
MGTA-145 will be given in various doses intravenously
Biologicalplerixafor
240 µg/kg subcutaneously
Also known as: Mozobil
BiologicalPlacebo
Placebo will be given in various doses intravenously

What researchers measure

Primary outcomes

Safety as measured by incidence of treatment-emergent adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs).
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)
Time frame: 28 days

Secondary outcomes

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

Study locations

1 site

Medpace CPU
Cincinnati, Ohio 45227, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03932864
Lead sponsor: Ensoma
Responsible party: Sponsor
First posted: May 1, 2019
Start date: Apr 22, 2019
Primary completion: Feb 25, 2020
Completion: Feb 25, 2020
Last update: Jan 11, 2024

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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