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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03932864
• Other study ID #: 145-HV-101
• Status: Completed
• Phase: Phase 1
• Start date: April 22, 2019
• Est. completion date: February 25, 2020

Study information

• Verified date: January 2024
• Source: Ensoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: February 25, 2020
• Est. primary completion date: February 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Biological:
• 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

Locations

Country	Name	City	State
United States	Medpace CPU	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ensoma

Country where clinical trial is conducted

United States, 

Outcome

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