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

Ensoma

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Biological: MGTA-145; Biological: plerixafor; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03932864

145-HV-101

Details and patient eligibility

About

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

Full 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.

Enrollment: 107 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age from 18 to 60 years
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

1. Any clinically significant laboratory value outside the normal range at screening
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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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107 participants in 4 patient groups, including a placebo group

Single Ascending Dose of MGTA-145 or placebo

Placebo Comparator group

Description:

MGTA-145 or placebo dose escalation as single agent, single dose

Treatment:

Biological: MGTA-145

Biological: Placebo

Single Dose MGTA-145 or placebo plus plerixafor

Placebo Comparator group

Description:

MGTA-145 or placebo in combination with plerixafor, single dose

Treatment:

Biological: MGTA-145

Biological: plerixafor

Biological: Placebo

Single dose MGTA-145 plus plerixafor for 2 sequential d

Experimental group

Description:

MGTA-145 in combination with plerixafor on two consecutive days; single dose per day

Treatment:

Biological: MGTA-145

Biological: plerixafor

Single dose MGTA-145 plus plerixafor followed by apheresis

Experimental group

Description:

MGTA-145 in combination with plerixafor followed by apheresis

Treatment:

Biological: MGTA-145

Biological: plerixafor