Study Assessing Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MGTA-145 in Healt… (NCT03932864) | Clinical Trial Compass
CompletedPhase 1
Study Assessing Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MGTA-145 in Healthy Volunteers as a Single Agent or in Combination With Plerixafor
United States107 participantsStarted 2019-04-22
Plain-language summary
To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MGTA-145 in healthy volunteers as a single agent and in combination with plerixafor.
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
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
What they're measuring
1
Safety as measured by incidence of treatment-emergent adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs).