Study Assessing Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MGTA-145 in Healthy Volunteers as a Single Agent or in Combination With Plerixafor
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
1 other identifier
interventional
107
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy-volunteers
Started Apr 2019
Typical duration for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2019
CompletedStudy Start
First participant enrolled
April 22, 2019
CompletedFirst Posted
Study publicly available on registry
May 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 25, 2020
CompletedJanuary 11, 2024
January 1, 2024
10 months
April 22, 2019
January 9, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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)
28 days
Secondary Outcomes (7)
Pharmacokinetics Biomarkers
15 days
Pharmacokinetics Biomarkers
15 days
Pharmacokinetic Biomarkers
15 days
Pharmacokinetic Biomarkers
15 days
Pharmacokinetic Biomarkers
15 days
- +2 more secondary outcomes
Study Arms (4)
Single Ascending Dose of MGTA-145 or placebo
PLACEBO COMPARATORMGTA-145 or placebo dose escalation as single agent, single dose
Single Dose MGTA-145 or placebo plus plerixafor
PLACEBO COMPARATORMGTA-145 or placebo in combination with plerixafor, single dose
Single dose MGTA-145 plus plerixafor for 2 sequential d
EXPERIMENTALMGTA-145 in combination with plerixafor on two consecutive days; single dose per day
Single dose MGTA-145 plus plerixafor followed by apheresis
EXPERIMENTALMGTA-145 in combination with plerixafor followed by apheresis
Interventions
MGTA-145 will be given in various doses intravenously
240 µg/kg subcutaneously
Placebo will be given in various doses intravenously
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ensomalead
Study Sites (1)
Medpace CPU
Cincinnati, Ohio, 45227, United States
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double Blind
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2019
First Posted
May 1, 2019
Study Start
April 22, 2019
Primary Completion
February 25, 2020
Study Completion
February 25, 2020
Last Updated
January 11, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share