Healthy VolunteersPhase 1NCT03932864
Study Assessing Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MGTA-145 in Healthy Volunteers as a Single Agent or in Combination With Plerixafor
A Phase 1 study testing MGTA-145 and plerixafor in people with Healthy Volunteers, run by Ensoma at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- MGTA-145 and plerixafor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2019to 25 Feb 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MGTA-145 in healthy volunteers as a single agent and in combination with plerixafor.
Read the detailed 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.
- Conditions
- Healthy Volunteers
- Being tested
- MGTA-145, plerixafor, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGTA-145Biological
MGTA-145 will be given in various doses intravenously
plerixaforBiological
Also called Mozobil
240 µg/kg subcutaneously
PlaceboBiological
Placebo will be given in various doses intravenously
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose of MGTA-145 or placebo | Placebo comparator | MGTA-145 or placebo dose escalation as single agent, single dose Receives: Biological: MGTA-145; Biological: Placebo |
| Single Dose MGTA-145 or placebo plus plerixafor | Placebo comparator | MGTA-145 or placebo in combination with plerixafor, single dose Receives: Biological: MGTA-145; Biological: plerixafor; Biological: Placebo |
| Single dose MGTA-145 plus plerixafor for 2 sequential d | Experimental | MGTA-145 in combination with plerixafor on two consecutive days; single dose per day Receives: Biological: MGTA-145; Biological: plerixafor |
| Single dose MGTA-145 plus plerixafor followed by apheresis | Experimental | MGTA-145 in combination with plerixafor followed by apheresis Receives: Biological: MGTA-145; Biological: plerixafor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 28 days
Secondary outcomes (7)
Pharmacokinetics Biomarkers
Investigate area under the curve (AUC) of MGTA-145
Measured: 15 days
Pharmacokinetics Biomarkers
Investigate maximum plasma concentration (Cmax) of MGTA-145
Measured: 15 days
Pharmacokinetic Biomarkers
Investigate clearance (CL) of MGTA-145
Measured: 15 days
Pharmacokinetic Biomarkers
Investigate the volume of distribution at steady state (Vdss) of MGTA-145
Measured: 15 days
Pharmacokinetic Biomarkers
Investigate the half-life of MGTA-145
Measured: 15 days
Pharmacodynamic Biomarkers
Assess CD34+ cells per uL of blood by flow cytometry
Measured: 15 days
Pharmacodynamic Biomarkers
Assess stem cell progenitors (colony forming units)
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start22 Apr 2019
- Primary completion25 Feb 2020
- Study completion25 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ensoma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932864
- Sponsor's protocol ID
- 145-HV-101
- Status last verified
- Jan 2024
- First submitted
- 22 Apr 2019
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03932864
- Acronym / sponsor ID
- 145-HV-101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- EnsomaIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 1 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MGTA-145 in healthy volunteers as a single agent and in combination with plerixafor.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose of MGTA-145 or placebo | Placebo comparator | Biological: MGTA-145, Biological: PlaceboMGTA-145 or placebo dose escalation as single agent, single dose |
| Single Dose MGTA-145 or placebo plus plerixafor | Placebo comparator | Biological: MGTA-145, Biological: plerixafor, Biological: PlaceboMGTA-145 or placebo in combination with plerixafor, single dose |
| Single dose MGTA-145 plus plerixafor for 2 sequential d | Experimental | Biological: MGTA-145, Biological: plerixaforMGTA-145 in combination with plerixafor on two consecutive days; single dose per day |
| Single dose MGTA-145 plus plerixafor followed by apheresis | Experimental | Biological: MGTA-145, Biological: plerixaforMGTA-145 in combination with plerixafor followed by apheresis |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MGTA-145MGTA-145 will be given in various doses intravenously | Biological | Single Ascending Dose of MGTA-145 or placebo, Single Dose MGTA-145 or placebo plus plerixafor, Single dose MGTA-145 plus plerixafor followed by apheresis, Single dose MGTA-145 plus plerixafor for 2 sequential d |
| plerixaforAlso: Mozobil240 µg/kg subcutaneously | Biological | Single Dose MGTA-145 or placebo plus plerixafor, Single dose MGTA-145 plus plerixafor followed by apheresis, Single dose MGTA-145 plus plerixafor for 2 sequential d |
| PlaceboPlacebo will be given in various doses intravenously | Biological | Single Ascending Dose of MGTA-145 or placebo, Single Dose MGTA-145 or placebo plus plerixafor |
Primary outcome
Safety as measured by incidence of treatment-emergent adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs).
Time frame: 28 days
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)
7 secondary outcomes
Pharmacokinetics Biomarkers
Time frame: 15 days
Pharmacokinetics Biomarkers
Time frame: 15 days
Pharmacokinetic Biomarkers
Time frame: 15 days
Pharmacokinetic Biomarkers
Time frame: 15 days
Pharmacokinetic Biomarkers
Time frame: 15 days
Pharmacodynamic Biomarkers
Time frame: 15 days
Pharmacodynamic Biomarkers
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MGTA-145 and plerixafor in people with Healthy Volunteers, run by Ensoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as measured by incidence of treatment-emergent adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs). (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024; AzTrials last refreshed its copy on 9 Nov 2026.