Study Assessing Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MGTA-145 in Healthy Volunteers as a Single Agent or in Combination With Plerixafor
NCT ID: NCT03932864
Last Updated: 2024-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
107 participants
INTERVENTIONAL
2019-04-22
2020-02-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Single Ascending Dose of MGTA-145 or placebo
MGTA-145 or placebo dose escalation as single agent, single dose
MGTA-145
MGTA-145 will be given in various doses intravenously
Placebo
Placebo will be given in various doses intravenously
Single Dose MGTA-145 or placebo plus plerixafor
MGTA-145 or placebo in combination with plerixafor, single dose
MGTA-145
MGTA-145 will be given in various doses intravenously
plerixafor
240 µg/kg subcutaneously
Placebo
Placebo will be given in various doses intravenously
Single dose MGTA-145 plus plerixafor for 2 sequential d
MGTA-145 in combination with plerixafor on two consecutive days; single dose per day
MGTA-145
MGTA-145 will be given in various doses intravenously
plerixafor
240 µg/kg subcutaneously
Single dose MGTA-145 plus plerixafor followed by apheresis
MGTA-145 in combination with plerixafor followed by apheresis
MGTA-145
MGTA-145 will be given in various doses intravenously
plerixafor
240 µg/kg subcutaneously
Interventions
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MGTA-145
MGTA-145 will be given in various doses intravenously
plerixafor
240 µg/kg subcutaneously
Placebo
Placebo will be given in various doses intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
60 Years
ALL
Yes
Sponsors
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Ensoma
INDUSTRY
Responsible Party
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Locations
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Medpace CPU
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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145-HV-101
Identifier Type: -
Identifier Source: org_study_id
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