HealthyPhase 1NCT03492385

Study to Evaluate the Safety, Tolerability, PK, and PD of PB2452 in Healthy Volunteers

A Phase 1 study testing PB2452 Infusion, Ticagrelor Oral Tablet - Pre-Treatment and Ticagrelor Oral Tablet - Pre-Treatment and Post-Treatment in people with Healthy, run by SFJ Pharmaceuticals, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a Phase 1, first-in-human, randomized, double-blind, placebo-controlled, single ascending dose, sequential group study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PB2452 with and without ticagrelor pretreatment when administered to healthy male and female subjects. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: PB2452 Infusion, Ticagrelor Oral Tablet - Pre-Treatment and Ticagrelor Oral Tablet - Pre-Treatment and Post-Treatment
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 64 participants
Where: 1 siteUnited States
Study dates: 3 Apr 2018to 18 Sep 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

The subject is male or female between 18 and 50 years of age, inclusive.
The subject has a body mass index between 18 and 35 kg/m2 and a weight of ≥50 kg but ≤120 kg, inclusive, at screening.
The subject is considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12 lead ECG results, and physical examination findings at screening.
Specific inclusionary laboratory values at screening and check-in require the following:
Aspartate transaminase (AST), alanine transaminase (ALT), total serum bilirubin and alkaline phosphatase levels within the normal range as defined by the clinical laboratory
White blood cell (WBC) count, platelet count and hemoglobin level within the normal range as defined by the clinical laboratory

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Thyroid stimulating hormone (TSH) level within the normal range as defined by the clinical laboratory at screening
Prothrombin time (PT) and partial thromboplastin time (PTT) level within the normal range as defined by the clinical laboratory
Female subjects of childbearing potential must not be pregnant, lactating, or planning to become pregnant before 3 months after the last dose of study drug, and have a negative serum pregnancy test at screening and check-in. Female subjects of childbearing potential must use 2 effective methods of birth control (ie, oral, implantable, patch, or injectable contraceptives in combination with a condom, hormone-containing intrauterine device that has been in place for at least 2 months prior to screening in combination with a condom, double-barrier method [ie, condoms, sponge, diaphragm, or cervical cap with spermicidal gels or cream], or vasectomy for male subjects or male partners of female subjects) from 30 days before study drug administration through the end of the study. Women are considered not to be of childbearing potential if they have fulfilled one of the following criteria: documentation of irreversible surgical sterilization (ie, hysterectomy, or bilateral oophorectomy [not tubal ligation]), or postmenopausal (defined as amenorrhea for 12 consecutive months following cessation of all exogenous hormonal treatments, and documented plasma follicle-stimulating hormone level >40 IU/mL or amenorrhea for 24 consecutive months). Male subjects with partners of childbearing potential must agree to use appropriate and effective measures of contraception (eg, condom plus diaphragm with spermicide; condom plus spermicide) during the study and for 30 days after the last dose of study drug, and to refrain from donating sperm for at least 7 days prior to the first dose of study drug until at least 90 days following the last dose of study drug.
The subject agrees to comply with all protocol requirements.
The subject is able to provide written informed consent.

Who cannot join

History of any clinically significant acute or chronic disease or medical disorder.
History or presence of gastrointestinal, hepatic (with the exception of Gilbert's syndrome), or renal disease or renal insufficiency (ie, estimated glomerular filtration rate <60 ml/min/1.73m2), or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study drug or any planned surgical procedure that will occur during the study (from screening through the Day 28 follow up visit).
Any clinically significant abnormal findings in physical examination, vital signs, laboratory assessments, and ECG parameters identified during screening or check-in.
Any history of arterial or venous thrombosis, including any of the following:
History of transient ischemic attack, cardiovascular accident, stroke (ischemic or hemorrhagic), unstable angina, myocardial infarction, or peripheral arterial disease

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History of deep venous thrombosis, pulmonary embolus, thrombophlebitis, or cavernous malformations
Any increased risk of bleeding, including the following:
Recent history (within 30 days preceding the first dose of study drug) of gastrointestinal bleeding
Any history of severe head trauma, intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation, aneurysm, or proliferative retinopathy
Any history of intracranial, intraocular, retroperitoneal, or spinal bleeding
Any recent (within 30 days preceding the first dose of study drug) major trauma
History of hemorrhagic disorders that may increase the risk of bleeding (eg, hemophilia, von Willebrand's disease)
Receiving chronic treatment with nonsteroidal anti-inflammatory drugs (including aspirin [greater than 100 mg daily]), anticoagulants, or other antiplatelet agents that cannot be discontinued (including clopidogrel, prasugrel, ticlopidine, dipyridamole, or cilostazol).
Have taken, within 30 days of screening, any oral or parenteral anticoagulant, including low molecular-weight heparin
Have taken non-steroidal anti-inflammatory medications, including aspirin, within 14 days of screening
The subject has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies at screening.
Any ongoing or recent (ie, during the screening period) minor medical complaints that may interfere with the interpretation of the study data or are considered unlikely to comply with study procedures, restrictions, and requirements as judged by the investigator.
Concomitant oral or IV therapy with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic indices, or strong CYP3A inducers, which cannot be stopped within at least 5 half-lives, but not shorter than 10 days, before randomization (a list of examples can be found in Section 6.2).
Any prescription (excluding hormonal birth control) or over the counter medications (except paracetamol [up to 2 g per day]), including herbal or nutritional supplements, within 14 days before the first dose of study drug.
The subject has consumed grapefruit or grapefruit juice, Seville orange or Seville orange containing products (eg, marmalade), or alcohol-, or xanthine containing products within 48 hours before dosing with study drug.
The subject is participating in any other study or is taking part in a non medication study which, in the opinion of the investigator, would interfere with the outcome of the study.
The subject has received another new chemical entity (defined as a compound which has not been approved for marketing) or any marketed or investigational biologic agent within 30 days of the first administration of study drug in this study. The period of exclusion begins 30 days after the final dose or 5 half-lives of the experimental medication has elapsed, whichever is longer.
The subject has involvement with any PhaseBio or study site employee or their close relatives (eg, spouse, parents, siblings, or children whether biological or legally adopted).
The subject has previously received MEDI2452 (PB2452).
The subject is a smoker or has used nicotine or nicotine containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers) within 3 months before the first dose of study drug.
The subject has a known or suspected history of drug abuse (including alcohol) or has a positive test result for drugs of abuse, alcohol, or cotinine (nicotine level above 300 ng/mL) at screening or check-in.
The subject has been involved in strenuous activity or contact sports within 24 hours before the first dose of study drug and while confined in the clinical site.
The subject has donated blood or plasma within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to the first dose of study drug.
The subject has a history of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to ticagrelor, any biologic therapeutic agent, or any significant food allergy that could preclude a standard diet in the clinical site.
Concern for the inability of the subject to comply with study procedures and/or follow up, or, in the opinion of the investigator, the subject is not suitable for entry into the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

PPD
Austin, Texas, 78744

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MEDI2452 (PB2452) With and Without Ticagrelor Pretreatment in Healthy Volunteers

Up to 6 dose levels will be evaluated. This study will have up to 10 cohorts and up to a total of approximately 76 subjects with either 4 or 8 healthy young subjects in Cohorts 1 through 9 or approximately 16 older subjects in Cohort 10. The starting dose of PB2452 will be 100 mg and the planned doses for subsequent cohorts are 300, 1000, 3000, 9000, and 18000 mg.

Conditions: Healthy
Being tested: PB2452 Infusion, Placebo - Sodium Chloride, Ticagrelor Oral Tablet - Pre-Treatment, Ticagrelor Oral Tablet - Pre-Treatment and Post-Treatment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PB2452 InfusionDrug
30 minute - 12 hour infusion
Placebo - Sodium ChlorideDrug
30 minute - 12 hour infusion
Ticagrelor Oral Tablet - Pre-TreatmentDrug
Ticagrelor 180 mg + 90 mg BID for 5 doses prior to MEDI2452 (PB2452) or Placebo
Ticagrelor Oral Tablet - Pre-Treatment and Post-TreatmentDrug
Ticagrelor 180 mg + 90 mg BID for 5 doses prior to MEDI2452 (PB2452) or Placebo and Ticagerlor 180 mg 24 hours following MEDI2452 (PB2452) or Placebo

Study groups in NCT03492385
Study group	Role	What they receive
1: 100 mg PB2452 or Placebo (no Ticagrelor)	Experimental	PB2452 Infusion or Placebo - Sodium Chloride Receives: Drug: PB2452 Infusion; Drug: Placebo - Sodium Chloride
2: 300 mg PB2452 or Placebo (no Ticagrelor)	Experimental	PB2452 Infusion or Placebo - Sodium Chloride Receives: Drug: PB2452 Infusion; Drug: Placebo - Sodium Chloride
3: 1000 mg PB2452 or Placebo (no Ticagrelor)	Experimental	PB2452 Infusion or Placebo - Sodium Chloride Receives: Drug: PB2452 Infusion; Drug: Placebo - Sodium Chloride
4: 1000 mg PB2452 or Placebo (Ticagrelor Pre-Trx)	Experimental	PB2452 Infusion or Placebo - Sodium Chloride With Ticagrelor Oral Tablet: 180 mg+90 mg BID for a total of 5 doses Receives: Drug: PB2452 Infusion; Drug: Placebo - Sodium Chloride
5: 3000 mg PB2452 or Placebo (Ticagrelor Pre-Trx)	Experimental	PB2452 Infusion or Placebo - Sodium Chloride with Ticagrelor Oral Tablet: 180 mg+90 mg BID for a total of 5 doses Receives: Drug: PB2452 Infusion; Drug: Placebo - Sodium Chloride; Drug: Ticagrelor Oral Tablet - Pre-Treatment
6: 9000 mg PB2452 or Placebo (Ticagrelor Pre-Trx)	Experimental	PB2452 Infusion or Placebo - Sodium Chloride with Ticagrelor Oral Tablet: 180 mg+90 mg BID for a total of 5 doses Receives: Drug: PB2452 Infusion; Drug: Placebo - Sodium Chloride; Drug: Ticagrelor Oral Tablet - Pre-Treatment
7: 18000 mg PB2452 or Placebo (Ticagrelor Pre-Trx)	Experimental	PB2452 Infusion or Placebo - Sodium Chloride with Ticagrelor Oral Tablet: 180 mg+90 mg BID for a total of 5 doses Receives: Drug: PB2452 Infusion; Drug: Placebo - Sodium Chloride; Drug: Ticagrelor Oral Tablet - Pre-Treatment
8: Dose TBD mg PB2452 or Placebo (Ticagrelor Pre-Trx)	Experimental	PB2452 Infusion or Placebo - Sodium Chloride with Ticagrelor Oral Tablet: 180 mg+90 mg BID for 5 doses Receives: Drug: PB2452 Infusion; Drug: Placebo - Sodium Chloride; Drug: Ticagrelor Oral Tablet - Pre-Treatment
9: Dose TBD mg PB2452 or Placebo (Ticagrelor Pre and Post-Trx)	Experimental	PB2452 Infusion or Placebo - Sodium Chloride with Ticagrelor Oral Tablet: 180 mg+90 mg BID for 5 doses and 180 mg 24 hours post-dose Receives: Drug: PB2452 Infusion; Drug: Placebo - Sodium Chloride; Drug: Ticagrelor Oral Tablet - Pre-Treatment and Post-Treatment
10: Dose TBD mg PB2452 or Placebo (Ticagrelor Pre-Txt)	Experimental	PB2452 Infusion or Placebo - Sodium Chloride with Ticagrelor Oral Tablet: 180 mg+90 mg BID for 5 doses Receives: Drug: PB2452 Infusion; Drug: Placebo - Sodium Chloride; Drug: Ticagrelor Oral Tablet - Pre-Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events (AEs)
An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related.
Measured: Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until Day 28
Number of Participants With Clinically Significant Laboratory Abnormalities
Number of participants with clinically significant abnormal laboratory findings for hematology, coagulation, serum chemistry, urinalysis and drug tests.
Measured: 30 Day - Starting day of dosing
Change in Diastolic Blood Pressure
Diastolic blood pressure measurements were measured at specific time points.
Measured: Days 1, 2, 3, 4, 7 and 28
Change in Systolic Blood Pressure
Systolic blood pressure measurements were measured at specific time points.
Measured: Days 1, 2, 3, 4, 7 and 28
Change In Oral Body Temperature
Body temperature measurements were measured at specific time points.
Measured: Days 1, 2, 3, 4, 7 and 28
Change In Respiratory Rate
Respiratory rate measurements were measured at specific time points.
Measured: Days 1, 2, 3, 4, 7 and 28
Change In Heart Rate
Heart rate measurements were measured at specific time points.
Measured: Days 1, 2, 3, 4, 7 and 28
Incidence of Clinically Significant 12-Lead Electrocardiogram (ECG) Findings
Number of participants per cohort with clinically significant ECG findings.
Measured: 60 days - Starting up to 28 days prior to dosing
Incidence of Clinically Significant Cardiac Telemetry Findings
Number of participants per cohort with clinically significant cardiac telemetry findings.
Measured: 3 Days - Starting 1 day prior to dosing up to 2 days after dosing
Participants Experiencing Anti-drug Antibodies (ADAs)
Incidence of Immunogenicity.
Measured: Day -3, Day -1, Day 7, and Day 28
Maximal Percent of Baseline Platelet Aggregation (PA(Max)) in Cohorts 4-6
Effectiveness Of Single Ascending Doses Of PB2452. IPA [maximum (max)] induced by 20 µM adenosine diphosphate (ADP) at each assessment point.
Measured: Before dosing and at 0.5, 1, 2, 3, 6, 12, 24, and 48 hours after PB2452 infusion and 5th ticagrelor dose.
Final Extent Percent of Baseline Platelet Aggregation in Cohorts 4-6
Effectiveness Of Single Ascending Doses Of PB2452. IPA [final extent] induced by 20 µM adenosine diphosphate (ADP) at each assessment point.
Measured: Before dosing and at 0.5, 1, 2, 3, 6, 12, 24, and 48 hours after PB2452 infusion and 5th ticagrelor dose.
Maximal Actual Platelet Aggregation (APA(Max)) (Cohorts 4-6)
Effectiveness Of Single Ascending Doses Of PB2452 - Inhibition of maximal platelet aggregation.
Measured: Before dosing and at 0.5, 1, 2, 3, 6, 12, 24, and 48 hours after PB2452 infusion and 5th ticagrelor dose. And at 1, 2, 6, and 12 hours after the Day 2 post-MEDI2452 (PB2452) 6th ticagrelor dose (Cohorts 8 and 9 Only).
Time to Maximum Platelet Aggregation (TPA(Max)) (Cohorts 4-6)
Effectiveness Of Single Ascending Doses Of PB2452 - Time to IPAmax.
Measured: Before dosing and at 0.5, 1, 2, 3, 6, 12, 24, and 48 hours after PB2452 infusion and 5th ticagrelor dose.
Maximal Percent of Baseline Platelet Aggregation (PA(Max)) (Cohorts 7-10)
Effectiveness Of Single Ascending Doses Of PB2452 - IPA (max) induced by 20 µM ADP at each assessment point.
Measured: Before dosing and at 5 min, 0.25, 0.5, 1, 2, 3, 6, 8, 10, 12, 16, 20, 24, and 48 hours after PB2452 infusion and 5th ticagrelor dose. And at 1, 2, 6, and 12 hours after the Day 2 post-MEDI2452 (PB2452) 6th ticagrelor dose.
Final Extent Percent of Baseline Platelet Aggregation (Cohorts 7-10)
Effectiveness Of Single Ascending Doses Of PB2452 - IPA (max) induced by 20 µM ADP at each assessment point.
Measured: Before dosing and at 5 min, 0.25, 0.5, 1, 2, 3, 6, 8, 10, 12, 16, 20, 24, and 48 hours after PB2452 infusion and 5th ticagrelor dose. And at 1, 2, 6, and 12 hours after the Day 2 post-MEDI2452 (PB2452) 6th ticagrelor dose.
Maximal Actual Platelet Aggregation (APA(Max)) (Cohorts 7-10)
Effectiveness Of Single Ascending Doses Of PB2452 - Inhibition of maximal platelet aggregation.
Measured: Before dosing and at 5 min, 0.25, 0.5, 1, 2, 3, 6, 8, 10, 12, 16, 20, 24, and 48 hours after PB2452 infusion and 5th ticagrelor dose. And at 1, 2, 6, and 12 hours after the Day 2 post-MEDI2452 (PB2452) 6th ticagrelor dose
Time to Maximum Platelet Aggregation (TPA(Max))(Cohorts 7-10)
Effectiveness Of Single Ascending Doses Of PB2452 - Time to IPAmax
Measured: Before dosing and at 5 min, 0.25, 0.5, 1, 2, 3, 6, 8, 10, 12, 16, 20, 24, and 48 hours after PB2452 infusion and 5th ticagrelor dose. And at 1, 2, 6, and 12 hours after the Day 2 post-MEDI2452 (PB2452) 6th ticagrelor dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Apr 201818 Sep 2018

First posted10 Apr 2018
Study start3 Apr 2018
Primary completion18 Sep 2018
Study completion18 Sep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies 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: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03492385
Sponsor's protocol ID: PB2452-PT-CL-0001
Status last verified: Aug 2024
First submitted: 2 Apr 2018
Last updated: 4 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Bhatt DL, Pollack CV, Weitz JI, Jennings LK, Xu S, Arnold SE, Umstead BR, Mays MC, Lee JS. Antibody-Based Ticagrelor Reversal Agent in Healthy Volunteers. N Engl J Med. 2019 May 9;380(19):1825-1833. doi: 10.1056/NEJMoa1901778. Epub 2019 Mar 17.
PubMed 30883047

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MEDI2452 (PB2452) With and Without Ticagrelor Pretreatment in Healthy Volunteers
ClinicalTrials.gov ID: NCT03492385
Acronym / sponsor ID: PB2452-PT-CL-0001
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: SFJ Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 3 Apr 2018 (actual)
Primary completion: 18 Sep 2018 (actual)
Study completion: 18 Sep 2018 (actual)
First posted: 10 Apr 2018 (actual)
Results: Posted 4 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 10

Arm	Type	Receives
1: 100 mg PB2452 or Placebo (no Ticagrelor)	Experimental	Drug: PB2452 Infusion, Drug: Placebo - Sodium ChloridePB2452 Infusion or Placebo - Sodium Chloride
2: 300 mg PB2452 or Placebo (no Ticagrelor)	Experimental	Drug: PB2452 Infusion, Drug: Placebo - Sodium ChloridePB2452 Infusion or Placebo - Sodium Chloride
3: 1000 mg PB2452 or Placebo (no Ticagrelor)	Experimental	Drug: PB2452 Infusion, Drug: Placebo - Sodium ChloridePB2452 Infusion or Placebo - Sodium Chloride
4: 1000 mg PB2452 or Placebo (Ticagrelor Pre-Trx)	Experimental	Drug: PB2452 Infusion, Drug: Placebo - Sodium ChloridePB2452 Infusion or Placebo - Sodium Chloride With Ticagrelor Oral Tablet: 180 mg+90 mg BID for a total of 5 doses
5: 3000 mg PB2452 or Placebo (Ticagrelor Pre-Trx)	Experimental	Drug: PB2452 Infusion, Drug: Placebo - Sodium Chloride, Drug: Ticagrelor Oral Tablet - Pre-TreatmentPB2452 Infusion or Placebo - Sodium Chloride with Ticagrelor Oral Tablet: 180 mg+90 mg BID for a total of 5 doses
6: 9000 mg PB2452 or Placebo (Ticagrelor Pre-Trx)	Experimental	Drug: PB2452 Infusion, Drug: Placebo - Sodium Chloride, Drug: Ticagrelor Oral Tablet - Pre-TreatmentPB2452 Infusion or Placebo - Sodium Chloride with Ticagrelor Oral Tablet: 180 mg+90 mg BID for a total of 5 doses
7: 18000 mg PB2452 or Placebo (Ticagrelor Pre-Trx)	Experimental	Drug: PB2452 Infusion, Drug: Placebo - Sodium Chloride, Drug: Ticagrelor Oral Tablet - Pre-TreatmentPB2452 Infusion or Placebo - Sodium Chloride with Ticagrelor Oral Tablet: 180 mg+90 mg BID for a total of 5 doses
8: Dose TBD mg PB2452 or Placebo (Ticagrelor Pre-Trx)	Experimental	Drug: PB2452 Infusion, Drug: Placebo - Sodium Chloride, Drug: Ticagrelor Oral Tablet - Pre-TreatmentPB2452 Infusion or Placebo - Sodium Chloride with Ticagrelor Oral Tablet: 180 mg+90 mg BID for 5 doses
9: Dose TBD mg PB2452 or Placebo (Ticagrelor Pre and Post-Trx)	Experimental	Drug: PB2452 Infusion, Drug: Placebo - Sodium Chloride, Drug: Ticagrelor Oral Tablet - Pre-Treatment and Post-TreatmentPB2452 Infusion or Placebo - Sodium Chloride with Ticagrelor Oral Tablet: 180 mg+90 mg BID for 5 doses and 180 mg 24 hours post-dose
10: Dose TBD mg PB2452 or Placebo (Ticagrelor Pre-Txt)	Experimental	Drug: PB2452 Infusion, Drug: Placebo - Sodium Chloride, Drug: Ticagrelor Oral Tablet - Pre-TreatmentPB2452 Infusion or Placebo - Sodium Chloride with Ticagrelor Oral Tablet: 180 mg+90 mg BID for 5 doses

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

The subject is male or female between 18 and 50 years of age, inclusive.
The subject has a body mass index between 18 and 35 kg/m2 and a weight of ≥50 kg but ≤120 kg, inclusive, at screening.
The subject is considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12 lead ECG results, and physical examination findings at screening.
Female subjects of childbearing potential must not be pregnant, lactating, or planning to become pregnant before 3 months after the last dose of study drug, and have a negative serum pregnancy test at screening and check-in. Female subjects of childbearing potential must use 2 effective methods of birth control (ie, oral, implantable, patch, or injectable contraceptives in combination with a condom, hormone-containing intrauterine device that has been in place for at least 2 months prior to screening in combination with a condom, double-barrier method [ie, condoms, sponge, diaphragm, or cervical cap with spermicidal gels or cream], or vasectomy for male subjects or male partners of female subjects) from 30 days before study drug administration through the end of the study. Women are considered not to be of childbearing potential if they have fulfilled one of the following criteria: documentation of irreversible surgical sterilization (ie, hysterectomy, or bilateral oophorectomy [not tubal ligation]), or postmenopausal (defined as amenorrhea for 12 consecutive months following cessation of all exogenous hormonal treatments, and documented plasma follicle-stimulating hormone level >40 IU/mL or amenorrhea for 24 consecutive months). Male subjects with partners of childbearing potential must agree to use appropriate and effective measures of contraception (eg, condom plus diaphragm with spermicide; condom plus spermicide) during the study and for 30 days after the last dose of study drug, and to refrain from donating sperm for at least 7 days prior to the first dose of study drug until at least 90 days following the last dose of study drug.
The subject agrees to comply with all protocol requirements.

Key exclusion criteria (31 listed)

History of any clinically significant acute or chronic disease or medical disorder.
History or presence of gastrointestinal, hepatic (with the exception of Gilbert's syndrome), or renal disease or renal insufficiency (ie, estimated glomerular filtration rate <60 ml/min/1.73m2), or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study drug or any planned surgical procedure that will occur during the study (from screening through the Day 28 follow up visit).
Any clinically significant abnormal findings in physical examination, vital signs, laboratory assessments, and ECG parameters identified during screening or check-in.
Any history of arterial or venous thrombosis, including any of the following:

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
PB2452 Infusion30 minute - 12 hour infusion	Drug	10: Dose TBD mg PB2452 or Placebo (Ticagrelor Pre-Txt), 1: 100 mg PB2452 or Placebo (no Ticagrelor), 2: 300 mg PB2452 or Placebo (no Ticagrelor), 3: 1000 mg PB2452 or Placebo (no Ticagrelor), 4: 1000 mg PB2452 or Placebo (Ticagrelor Pre-Trx), 5: 3000 mg PB2452 or Placebo (Ticagrelor Pre-Trx), 6: 9000 mg PB2452 or Placebo (Ticagrelor Pre-Trx), 7: 18000 mg PB2452 or Placebo (Ticagrelor Pre-Trx), 8: Dose TBD mg PB2452 or Placebo (Ticagrelor Pre-Trx), 9: Dose TBD mg PB2452 or Placebo (Ticagrelor Pre and Post-Trx)
Placebo - Sodium Chloride30 minute - 12 hour infusion	Drug	10: Dose TBD mg PB2452 or Placebo (Ticagrelor Pre-Txt), 1: 100 mg PB2452 or Placebo (no Ticagrelor), 2: 300 mg PB2452 or Placebo (no Ticagrelor), 3: 1000 mg PB2452 or Placebo (no Ticagrelor), 4: 1000 mg PB2452 or Placebo (Ticagrelor Pre-Trx), 5: 3000 mg PB2452 or Placebo (Ticagrelor Pre-Trx), 6: 9000 mg PB2452 or Placebo (Ticagrelor Pre-Trx), 7: 18000 mg PB2452 or Placebo (Ticagrelor Pre-Trx), 8: Dose TBD mg PB2452 or Placebo (Ticagrelor Pre-Trx), 9: Dose TBD mg PB2452 or Placebo (Ticagrelor Pre and Post-Trx)
Ticagrelor Oral Tablet - Pre-TreatmentTicagrelor 180 mg + 90 mg BID for 5 doses prior to MEDI2452 (PB2452) or Placebo	Drug	10: Dose TBD mg PB2452 or Placebo (Ticagrelor Pre-Txt), 5: 3000 mg PB2452 or Placebo (Ticagrelor Pre-Trx), 6: 9000 mg PB2452 or Placebo (Ticagrelor Pre-Trx), 7: 18000 mg PB2452 or Placebo (Ticagrelor Pre-Trx), 8: Dose TBD mg PB2452 or Placebo (Ticagrelor Pre-Trx)
Ticagrelor Oral Tablet - Pre-Treatment and Post-TreatmentTicagrelor 180 mg + 90 mg BID for 5 doses prior to MEDI2452 (PB2452) or Placebo and Ticagerlor 180 mg 24 hours following MEDI2452 (PB2452) or Placebo	Drug	9: Dose TBD mg PB2452 or Placebo (Ticagrelor Pre and Post-Trx)

Primary outcome

Number of Participants With Adverse Events (AEs)
Time frame: Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until Day 28
An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related.
Number of Participants With Clinically Significant Laboratory Abnormalities
Time frame: 30 Day - Starting day of dosing
Number of participants with clinically significant abnormal laboratory findings for hematology, coagulation, serum chemistry, urinalysis and drug tests.
Change in Diastolic Blood Pressure
Time frame: Days 1, 2, 3, 4, 7 and 28
Diastolic blood pressure measurements were measured at specific time points.
Change in Systolic Blood Pressure
Time frame: Days 1, 2, 3, 4, 7 and 28
Systolic blood pressure measurements were measured at specific time points.
Change In Oral Body Temperature
Time frame: Days 1, 2, 3, 4, 7 and 28
Body temperature measurements were measured at specific time points.
Change In Respiratory Rate
Time frame: Days 1, 2, 3, 4, 7 and 28
Respiratory rate measurements were measured at specific time points.
Change In Heart Rate
Time frame: Days 1, 2, 3, 4, 7 and 28
Heart rate measurements were measured at specific time points.
Incidence of Clinically Significant 12-Lead Electrocardiogram (ECG) Findings
Time frame: 60 days - Starting up to 28 days prior to dosing
Number of participants per cohort with clinically significant ECG findings.
Incidence of Clinically Significant Cardiac Telemetry Findings
Time frame: 3 Days - Starting 1 day prior to dosing up to 2 days after dosing
Number of participants per cohort with clinically significant cardiac telemetry findings.
Participants Experiencing Anti-drug Antibodies (ADAs)
Time frame: Day -3, Day -1, Day 7, and Day 28
Incidence of Immunogenicity.
Maximal Percent of Baseline Platelet Aggregation (PA(Max)) in Cohorts 4-6
Time frame: Before dosing and at 0.5, 1, 2, 3, 6, 12, 24, and 48 hours after PB2452 infusion and 5th ticagrelor dose.
Effectiveness Of Single Ascending Doses Of PB2452. IPA [maximum (max)] induced by 20 µM adenosine diphosphate (ADP) at each assessment point.
Final Extent Percent of Baseline Platelet Aggregation in Cohorts 4-6
Time frame: Before dosing and at 0.5, 1, 2, 3, 6, 12, 24, and 48 hours after PB2452 infusion and 5th ticagrelor dose.
Effectiveness Of Single Ascending Doses Of PB2452. IPA [final extent] induced by 20 µM adenosine diphosphate (ADP) at each assessment point.
Maximal Actual Platelet Aggregation (APA(Max)) (Cohorts 4-6)
Time frame: Before dosing and at 0.5, 1, 2, 3, 6, 12, 24, and 48 hours after PB2452 infusion and 5th ticagrelor dose. And at 1, 2, 6, and 12 hours after the Day 2 post-MEDI2452 (PB2452) 6th ticagrelor dose (Cohorts 8 and 9 Only).
Effectiveness Of Single Ascending Doses Of PB2452 - Inhibition of maximal platelet aggregation.
Time to Maximum Platelet Aggregation (TPA(Max)) (Cohorts 4-6)
Time frame: Before dosing and at 0.5, 1, 2, 3, 6, 12, 24, and 48 hours after PB2452 infusion and 5th ticagrelor dose.
Effectiveness Of Single Ascending Doses Of PB2452 - Time to IPAmax.
Maximal Percent of Baseline Platelet Aggregation (PA(Max)) (Cohorts 7-10)
Time frame: Before dosing and at 5 min, 0.25, 0.5, 1, 2, 3, 6, 8, 10, 12, 16, 20, 24, and 48 hours after PB2452 infusion and 5th ticagrelor dose. And at 1, 2, 6, and 12 hours after the Day 2 post-MEDI2452 (PB2452) 6th ticagrelor dose.
Effectiveness Of Single Ascending Doses Of PB2452 - IPA (max) induced by 20 µM ADP at each assessment point.
Final Extent Percent of Baseline Platelet Aggregation (Cohorts 7-10)
Time frame: Before dosing and at 5 min, 0.25, 0.5, 1, 2, 3, 6, 8, 10, 12, 16, 20, 24, and 48 hours after PB2452 infusion and 5th ticagrelor dose. And at 1, 2, 6, and 12 hours after the Day 2 post-MEDI2452 (PB2452) 6th ticagrelor dose.
Effectiveness Of Single Ascending Doses Of PB2452 - IPA (max) induced by 20 µM ADP at each assessment point.
Maximal Actual Platelet Aggregation (APA(Max)) (Cohorts 7-10)
Time frame: Before dosing and at 5 min, 0.25, 0.5, 1, 2, 3, 6, 8, 10, 12, 16, 20, 24, and 48 hours after PB2452 infusion and 5th ticagrelor dose. And at 1, 2, 6, and 12 hours after the Day 2 post-MEDI2452 (PB2452) 6th ticagrelor dose
Effectiveness Of Single Ascending Doses Of PB2452 - Inhibition of maximal platelet aggregation.
Time to Maximum Platelet Aggregation (TPA(Max))(Cohorts 7-10)
Time frame: Before dosing and at 5 min, 0.25, 0.5, 1, 2, 3, 6, 8, 10, 12, 16, 20, 24, and 48 hours after PB2452 infusion and 5th ticagrelor dose. And at 1, 2, 6, and 12 hours after the Day 2 post-MEDI2452 (PB2452) 6th ticagrelor dose.
Effectiveness Of Single Ascending Doses Of PB2452 - Time to IPAmax

Results and safety

Results posted to the registry on 4 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: 100 mg PB2452 (no Ticagrelor)	3	3
Cohort 2: 300 mg PB2452 (no Ticagrelor)	3	3
Cohort 3: 1000 mg PB2452 (no Ticagrelor)	3	3
Cohort 1 to 3: Placebo	3	3
Cohort 4: 1000 mg PB2452 (Ticagrelor Pre-Trx)	6	6
Cohort 5: 3000 mg PB2452 (Ticagrelor Pre-Trx)	6	6
Cohort 6: 9000 mg PB2452 (Ticagrelor Pre-Trx)	6	6
Cohort 4 to 6: Placebo	6	6
Cohort 7: 18000 mg PB2452 (Ticagrelor Pre-Trx)	6	6
Cohort 8: 18000 mg PB2452 (Ticagrelor Pre-Trx)	6	6
Cohort 9: 18000 mg PB2452 (Ticagrelor Pre-Trx)	3	3
Cohort 10: 18000 mg PB2452 (Ticagrelor Pre-Trx)	6	6
Cohort 7 to 10: Placebo	7	7

Primary outcome: Number of Participants With Adverse Events (AEs)

Time frame: Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until Day 28. Count of participants. Unit: Participants

Measure	Cohort 3: 1000 mg PB2452 (no Ticagrelor) n = 3	Cohort 1 to 3: Placebo n = 3	Cohort 4: 1000 mg PB2452 (Ticagrelor Pre-Trx) n = 6	Cohort 6: 9000 mg PB2452 (Ticagrelor Pre-Trx) n = 6	Cohort 4 to 6: Placebo n = 6	Cohort 7: 18000 mg PB2452 (Ticagrelor Pre-Trx) n = 6	Cohort 8: 18000 mg PB2452 (Ticagrelor Pre-Trx) n = 6	Cohort 9: 18000 mg PB2452 (Ticagrelor Pre-Trx) n = 3	Cohort 10: 18000 mg PB2452 (Ticagrelor Pre-Trx) n = 6
Any Treatment-Emergent AE	1	1	3	6	1	2	2	1	2
Any study-drug-related TEAE	0	0	0	0	0	0	0	0	0
Any severe TEAE	0	0	1	0	0	0	0	0	0
Any SAE	0	0	1	0	0	0	0	0	0
Any AE leading to early study discontinuation	0	0	0	0	0	0	0	0	0
Any dose limiting toxicity	0	0	0	0	0	0	0	0	0
Any death	0	0	0	0	0	0	0	0	0

Population analysed: Safety population: all participants who received any amount of study drug.

Primary outcome: Number of Participants With Clinically Significant Laboratory Abnormalities

Time frame: 30 Day - Starting day of dosing. Count of participants. Unit: Participants

Measure	Cohort 1: 100 mg PB2452 (no Ticagrelor) n = 3	Cohort 2: 300 mg PB2452 (no Ticagrelor) n = 3	Cohort 3: 1000 mg PB2452 (no Ticagrelor) n = 3	Cohort 1 to 3: Placebo n = 3	Cohort 4: 1000 mg PB2452 (Ticagrelor Pre-Trx) n = 6	Cohort 5: 3000 mg PB2452 (Ticagrelor Pre-Trx) n = 6	Cohort 6: 9000 mg PB2452 (Ticagrelor Pre-Trx) n = 6	Cohort 4 to 6: Placebo n = 6	Cohort 7: 18000 mg PB2452 (Ticagrelor Pre-Trx) n = 6	Cohort 8: 18000 mg PB2452 (Ticagrelor Pre-Trx) n = 6	Cohort 9: 18000 mg PB2452 (Ticagrelor Pre-Trx) n = 3	Cohort 10: 18000 mg PB2452 (Ticagrelor Pre-Trx) n = 6	Cohort 7 to 10: Placebo n = 7
Value	0	0	0	0	0	0	0	0	0	0	0	0	0

Population analysed: Safety population: all participants who received any amount of study drug.

Primary outcome: Change in Diastolic Blood Pressure

Time frame: Days 1, 2, 3, 4, 7 and 28. Mean (Standard Deviation). Unit: mmHg

Measure	Cohort 1: 100 mg PB2452 (no Ticagrelor) n = 3	Cohort 2: 300 mg PB2452 (no Ticagrelor) n = 3	Cohort 3: 1000 mg PB2452 (no Ticagrelor) n = 3	Cohort 1 to 3: Placebo n = 3	Cohort 4: 1000 mg PB2452 (Ticagrelor Pre-Trx) n = 6	Cohort 5: 3000 mg PB2452 (Ticagrelor Pre-Trx) n = 6	Cohort 6: 9000 mg PB2452 (Ticagrelor Pre-Trx) n = 6	Cohort 4 to 6: Placebo n = 6	Cohort 7: 18000 mg PB2452 (Ticagrelor Pre-Trx) n = 6	Cohort 8: 18000 mg PB2452 (Ticagrelor Pre-Trx) n = 6	Cohort 9: 18000 mg PB2452 (Ticagrelor Pre-Trx) n = 3	Cohort 10: 18000 mg PB2452 (Ticagrelor Pre-Trx) n = 6	Cohort 7 to 10: Placebo n = 7
Change from Baseline - Day 1/0.5 Hour	1.7 (6.66)	-2.3 (7.57)	5.7 (3.21)	-1.7 (10.02)	-0.8 (7.76)	-2.7 (5.39)	-0.5 (3.39)	-1.3 (5.13)	-2.5 (3.70)	4.5 (3.51)	-4.0 (4.58)	-2.5 (5.96)	-1.4 (8.30)
Change from Baseline - Day 1/0.75 Hour	0.7 (10.21)	-1.0 (8.89)	3.3 (6.43)	-0.3 (9.07)	0.3 (9.29)	-1.0 (1.79)	-1.2 (3.54)	1.3 (5.54)	1.5 (9.97)	-0.3 (7.28)	-2.3 (1.53)	-2.0 (6.48)	-0.4 (8.92)
Change from Baseline - Day 1/1 Hour	-0.7 (11.37)	0 (4.58)	2.7 (6.66)	4.0 (6.24)	3.5 (8.78)	0.3 (3.33)	0.3 (3.98)	2.8 (6.43)	3.8 (11.18)	0.5 (5.54)	-6.7 (1.53)	-1.7 (6.83)	2.1 (9.69)
Change from Baseline - Day 1/2 Hour	12.7 (7.23)

Primary outcome: Change in Systolic Blood Pressure

Time frame: Days 1, 2, 3, 4, 7 and 28. Mean (Standard Deviation). Unit: mmHg

Measure	Cohort 1: 100 mg PB2452 (no Ticagrelor) n = 3	Cohort 2: 300 mg PB2452 (no Ticagrelor) n = 3	Cohort 3: 1000 mg PB2452 (no Ticagrelor) n = 3	Cohort 1 to 3: Placebo n = 3	Cohort 4: 1000 mg PB2452 (Ticagrelor Pre-Trx) n = 6	Cohort 5: 3000 mg PB2452 (Ticagrelor Pre-Trx) n = 6	Cohort 6: 9000 mg PB2452 (Ticagrelor Pre-Trx) n = 6	Cohort 4 to 6: Placebo n = 6	Cohort 7: 18000 mg PB2452 (Ticagrelor Pre-Trx) n = 6	Cohort 8: 18000 mg PB2452 (Ticagrelor Pre-Trx) n = 6	Cohort 9: 18000 mg PB2452 (Ticagrelor Pre-Trx) n = 3	Cohort 10: 18000 mg PB2452 (Ticagrelor Pre-Trx) n = 6	Cohort 7 to 10: Placebo n = 7
Change from Baseline - Day 1/0.5 Hour	3.0 (15.10)	-0.7 (8.33)	6.7 (6.51)	0.3 (12.86)	-4.8 (4.75)	-0.3 (2.42)	1.3 (2.73)	-3.0 (6.87)	1.5 (6.61)	-0.3 (8.30)	4.7 (7.37)	-1.7 (4.63)	-0.7 (4.68)
Change from Baseline - Day 1/0.75 Hour	4.0 (5.00)	2.0 (4.36)	2.3 (6.03)	1.0 (13.23)	-1.2 (6.24)	0.2 (3.43)	2.8 (2.93)	1.3 (8.12)	11.5 (12.93)	-1.2 (11.13)	-6.0 (5.29)	-3.3 (4.80)	-1.4 (7.28)
Change from Baseline - Day 1/1 Hour	7.7 (5.13)	2.7 (3.06)	3.0 (4.58)	2.0 (4.36)	2.7 (5.20)	1.7 (5.61)	1.2 (1.72)	-0.5 (6.44)	8.0 (12.21)	0.2 (6.85)	4.7 (7.57)	-1.7 (6.65)	1.0 (9.04)
Change from Baseline - Day 1/2 Hour	5.7 (10.21)	-1.3 (4.93)

Adverse events

Time frame: Adverse events were assessed from Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until completion of all study procedures and EOS assessments (Day 28).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: 100 mg PB2452 (no Ticagrelor)	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Cohort 2: 300 mg PB2452 (no Ticagrelor)	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Cohort 3: 1000 mg PB2452 (no Ticagrelor)	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
Cohort 1 to 3: Placebo	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
Cohort 4: 1000 mg PB2452 (Ticagrelor Pre-Trx)	1 of 6 (16.7%)	3 of 6 (50%)	0 of 6
Cohort 5: 3000 mg PB2452 (Ticagrelor Pre-Trx)	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Cohort 6: 9000 mg PB2452 (Ticagrelor Pre-Trx)	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Cohort 4 to 6: Placebo	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Cohort 7: 18000 mg PB2452 (Ticagrelor Pre-Trx)	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Cohort 8: 18000 mg PB2452 (Ticagrelor Pre-Trx)	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Cohort 9: 18000 mg PB2452 (Ticagrelor Pre-Trx)	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
Cohort 10: 18000 mg PB2452 (Ticagrelor Pre-Trx)	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Cohort 7 to 10: Placebo	0 of 7 (0%)	0 of 7 (0%)	0 of 7
All PB2452	1 of 48 (2.1%)	17 of 48 (35.4%)	0 of 48
All Placebo	0 of 16 (0%)	2 of 16 (12.5%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30883047Bhatt DL, Pollack CV, Weitz JI, Jennings LK, Xu S, Arnold SE, Umstead BR, Mays MC, Lee JS. Antibody-Based Ticagrelor Reversal Agent in Healthy Volunteers. N Engl J Med. 2019 May 9;380(19):1825-1833. doi: 10.1056/NEJMoa1901778. Epub 2019 Mar 17.
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.

LuAnn Bundrant, MD principal investigator

PPD Development, LP

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 11 inclusion and 31 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 4 Nov 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. 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?

Yes. Results are posted in the registry (first posted 4 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Adverse Events (AEs) (time frame: Day -3 (Cohorts 4 through 10) or Day -1 (Cohorts 1 through 3) until Day 28). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03492385, which also lists 1 linked publication.

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 4 Nov 2024.