Healthy SubjectsPhase 1NCT02376036
Phase 1 Study of MGD010 in Healthy Subjects
A Phase 1 study testing MGD010 and Hepatitis A vaccine in people with Healthy Subjects, run by MacroGenics at 1 site in United States.
Trial summary
The primary goal of this Phase 1 study is to assess the safety and tolerability of one MGD010 intravenous (IV) infusion in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- MGD010 and Hepatitis A vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Feb 2017
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 18 and 50 years of age
- Body mass index (BMI) of 18 to 30 kg/m2, inclusive
Who cannot join
- Women of child-bearing potential;
- Women who are pregnant or breast-feeding
- Any significant acute or chronic medical illness
- Any major surgery within 4 weeks of study drug administration
- Active or latent tuberculosis (TB)
- Active or latent Hepatitis B, Hepatitis C or HIV infection
Show all 10Show fewer
- History of allergy to monoclonal antibodies, any significant drug allergy (such as anaphylaxis), or hypersensitivity to any components of the test or reference investigational product formulation.
- Evidence of organ dysfunction or any clinically significant deviation from normal
- Vaccination with any live vaccine, or use of any prescription drugs, within 4 weeks of study drug administration
- Known history of infection or exposure to Hepatitis A virus
Trial locations and contacts
1 site in 1 country.
United States1 site
PAREXEL Baltimore Early Phase Clinical Unit
Baltimore, Maryland, 21225
About this study
Official title: A Phase 1, First-in-Human, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of MGD010, a CD32B x CD79B Dual Affinity Re-Targeting (DART®) Bi-specific Antibody-Based Molecule, in Healthy Subjects
The primary goal of this Phase 1 study is to assess the safety and tolerability of one MGD010 intravenous (IV) infusion in healthy adult volunteers.
Read the detailed description
This is a Phase 1 study to evaluate the safety, tolerability and PK of MGD010, a CD32B x CD79B DART bi-specific antibody-based molecule. This study will be conducted as a double-blind, randomized, placebo controlled, single ascending dose study among healthy subjects.
- Conditions
- Healthy Subjects
- Being tested
- MGD010, Placebo, Hepatitis A vaccine
- Keywords
- Normal healthy volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGD010Drug
MGD010 is a CD32B x CD79B bi-specific antibody-based molecular construct referred to as a Dual Affinity Re-Targeting (DART) molecule. MGD010 will be administered as a single agent.
PlaceboDrug
Placebo comparator.
Hepatitis A vaccineBiological
Also called Vaqta
Hepatitis A vaccine, inactivated
| Study group | Role | What they receive |
|---|---|---|
| MGD010 | Experimental | Subjects will receive MGD010 through IV infusion. Receives: Drug: MGD010 |
| Placebo | Placebo comparator | Subjects will receive placebo through IV infusion. Receives: Drug: Placebo |
| MGD010 and HepA vaccine | Experimental | Subjects will receive MGD010 through IV infusion and HepA vaccine through an IM injection. Receives: Drug: MGD010; Biological: Hepatitis A vaccine |
| Placebo and HepA vaccine | Placebo comparator | Subjects will receive placebo through IV infusion and HepA vaccine through an IM injection. Receives: Drug: Placebo; Biological: Hepatitis A vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability as assessed by AEs and SAEs
Measured: up to Day 57
Secondary outcomes (2)
Serum concentration (pharmacokinetics) of MGD010
Measured: up to Day 57
Incidence of MGD010 anti-drug antibodies (ADA)
Measured: up to Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- MacroGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, MacroGenics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376036
- Sponsor's protocol ID
- CP-MGD010-01
- Status last verified
- Feb 2022
- First submitted
- 24 Feb 2015
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-Human, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of MGD010, a CD32B x CD79B Dual Affinity Re-Targeting (DART®) Bi-specific Antibody-Based Molecule, in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02376036
- Acronym / sponsor ID
- CP-MGD010-01
- Conditions
- Healthy Subjects
- Keywords
- Normal healthy volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- MacroGenicsIndustry (pharma, biotech, devices)
- Study start
- Feb 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 3 Mar 2015 (estimated)
- 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.
The primary goal of this Phase 1 study is to assess the safety and tolerability of one MGD010 intravenous (IV) infusion in healthy adult volunteers.
Detailed description
This is a Phase 1 study to evaluate the safety, tolerability and PK of MGD010, a CD32B x CD79B DART bi-specific antibody-based molecule. This study will be conducted as a double-blind, randomized, placebo controlled, single ascending dose study among healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MGD010 | Experimental | Drug: MGD010Subjects will receive MGD010 through IV infusion. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will receive placebo through IV infusion. |
| MGD010 and HepA vaccine | Experimental | Drug: MGD010, Biological: Hepatitis A vaccineSubjects will receive MGD010 through IV infusion and HepA vaccine through an IM injection. |
| Placebo and HepA vaccine | Placebo comparator | Drug: Placebo, Biological: Hepatitis A vaccineSubjects will receive placebo through IV infusion and HepA vaccine through an IM injection. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Between 18 and 50 years of age
- Body mass index (BMI) of 18 to 30 kg/m2, inclusive
Key exclusion criteria (10 listed)
- Women of child-bearing potential;
- Women who are pregnant or breast-feeding
- Any significant acute or chronic medical illness
- Any major surgery within 4 weeks of study drug administration
- Active or latent tuberculosis (TB)
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 |
|---|---|---|
| MGD010MGD010 is a CD32B x CD79B bi-specific antibody-based molecular construct referred to as a Dual Affinity Re-Targeting (DART) molecule. MGD010 will be administered as a single agent. | Drug | MGD010, MGD010 and HepA vaccine |
| PlaceboPlacebo comparator. | Drug | Placebo, Placebo and HepA vaccine |
| Hepatitis A vaccineAlso: VaqtaHepatitis A vaccine, inactivated | Biological | MGD010 and HepA vaccine, Placebo and HepA vaccine |
Primary outcome
Safety and Tolerability as assessed by AEs and SAEs
Time frame: up to Day 57
2 secondary outcomes
Serum concentration (pharmacokinetics) of MGD010
Time frame: up to Day 57
Incidence of MGD010 anti-drug antibodies (ADA)
Time frame: up to Day 57
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 8 Feb 2022.
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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.
Chief Medical Officer study director
MacroGenics
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 MGD010 and Hepatitis A vaccine in people with Healthy Subjects, run by MacroGenics 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 2 inclusion and 10 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 8 Feb 2022. 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 and Tolerability as assessed by AEs and SAEs (time frame: up to Day 57). 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 8 Feb 2022.