HealthyPhase 2NCT03928353
Study to Evaluate the Safety, Tolerability, PK and PD of PB2452 in Healthy Younger, Older and Elderly Subjects
A Phase 2 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.
Trial summary
This is a Phase 2A, randomized, double-blind, placebo-controlled, single dose, sequential group study to evaluate the safety, tolerability, PK, and PD of PB2452 vs matching placebo with ticagrelor (with or without acetylsalicylic acid (ASA)) pretreatment when various dose levels and administration regimens are… Read more about this study
- Who is it for?
- Ages 18 to 80 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
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2019to 9 Oct 2019
- Phase
- Phase 2
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subject provides written informed consent and agrees to comply with all protocol requirements.
- The subject is male or female between 18 and 80 years of age, inclusive (50 to 80 years for Cohorts 1-2, 18 to 50 years for Cohorts 3-5).
- The subject has a body mass index (BMI) 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. Older and elderly subjects with chronic, stable, and well-controlled medical conditions are eligible provided they meet all other inclusion/exclusion criteria. Some examples of stable and well-controlled medical conditions include but are not limited to:
- Hypertension (HTN) controlled with ≤2 antihypertensive drugs
- Diabetes controlled with diet/exercise or treated with up to 2 oral diabetes medications
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- Subjects with diabetes must have a glycated hemoglobin HbA1c ≤8 mg/dL at Screening.
- Mild hepatic enzyme elevation (aspartate aminotransferase (AST) or alanine transaminase (ALT) <1.5 x ULN or total bilirubin <1.2 x ULN)
- Controlled hyperlipidemia (defined with a Screening low density lipoprotein LDL <160 mg/dL)
- Specific inclusionary laboratory values at Screening and Check-in require:
- White blood cell (WBC) count, platelet count, hemoglobin (Hgb) level within normal range, as defined by the clinical laboratory
- Thyroid stimulating hormone (TSH) level within normal range, as defined by the clinical laboratory at Screening
- Prothrombin time (PT) and partial thromboplastin time (PTT) level within normal range, as defined by the clinical laboratory
- Subjects taking medications for well-controlled medical conditions must have been on a stable dose (meaning no changes in dose) for at least 30 days prior to Screening visit.
- Older and elderly subjects entering the study who are not already taking daily ASA must be willing to start an 81 mg daily dose of ASA on Day -7 and continue daily dosing until the final dose is administered on the morning of Day 1. Subjects entering the study who are already taking ASA daily will be administered 81 mg ASA daily between Day -7 and Day 1 and must suspend further ASA dosing until discharge from the clinical facility.
- Female subjects of childbearing potential must not be pregnant, lactating, or planning to become pregnant for 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 from 30 days before study drug administration through to the end of the study.
- Effective birth control methods include oral, implantable, patch, or injectable contraceptive hormone treatment, hormone-containing intrauterine device that has been in place ≥2 months prior to Screening, sponge, diaphragm, or cervical cap with spermicidal gel or cream for female subjects or condom or vasectomy for male subjects.
- Women are considered to not be of childbearing potential if they have fulfilled one of these criteria: documentation of irreversible surgical sterilization (i.e., hysterectomy or bilateral oophorectomy [not tubal ligation]) or are postmenopausal (defined as amenorrhea for 12 consecutive months following cessation of all exogenous hormonal treatments, and documented plasma follicle-stimulating hormone (FSH) 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 (e.g., condom plus diaphragm with spermicide, condom plus spermicide) during the study and for 30 days after the last dose of study drug, and refrain from donating sperm for ≥90 days following the last dose of study drug.
Who cannot join
- Concern the subject may be unable 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
- History of any acute or chronic medical disorder expected to decrease the life expectancy of the subject
- History or presence of gastrointestinal (GI), hepatic (with the exception of Gilbert's syndrome), or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
- Significant renal insufficiency, as indicated by estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 according to the Modification of Diet in Renal Disease (MDRD) equation
- Any clinically significant (CS) acute illness, medical/surgical procedure, or trauma within 4 weeks of administration of study drug or any planned surgical procedure that will occur during the study (from Screening through the Day 28 [±2 days] Follow-up visit)
- Any CS abnormal findings in physical examination, vital signs, laboratory assessments, and ECG parameters identified during Screening or Check-in. Note: abnormal results may be repeated for confirmation immediately after the first out of range measurement. Abnormal vital signs may be repeated twice if needed, immediately after the first abnormal result and/or after the subject has rested for at least 10 minutes.
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- Specific vital sign exclusionary criteria occurring after 10 minutes of supine rest are any of the following:
- Systolic blood pressure (SBP) <100 or >160 mm Hg
- Diastolic blood pressure (DBP) <40 or >95 mm Hg
- Resting heart rate (HR) <50 or >100 beats per minute (bpm)
- Specific exclusionary criteria for ECG parameters at Screening or Check-in include any of the following:
- Prolonged Fridericia-corrected QT interval (QTcF) >450 milliseconds (msec)
- Shortened QTcF <340 msec, or pause >3 seconds
- Family history of long QT syndrome
- Any specific contraindication to Brilinta® as described in the Brilinta® prescribing information and:
- History of intracranial hemorrhage, active bleeding, or hypersensitivity or allergic reaction to ticagrelor or any component of the product
- Any history of severe head trauma, intracranial neoplasm, arteriovenous malformation, aneurysm, or proliferative retinopathy
- Any history of intraocular, retroperitoneal, or spinal bleeding
- Have taken, within 30 days of Screening, any oral or parenteral anticoagulant, including low molecular-weight heparin
- Stool sample testing positive for occult blood within 3 months of Screening or at any time during the Screening Period
- Receiving chronic treatment with nonsteroidal anti-inflammatory drugs (NSAIDS; [including ASA >100 mg daily]), anticoagulants, or other antiplatelet agents that cannot be discontinued 14 days prior to randomization (including clopidogrel, prasugrel, ticlopidine, dipyridamole, or cilostazol)
- Positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) types 1 or 2 antibodies at Screening
- Concomitant oral or IV therapy with strong cytochrome P450 3A4 (CYP3A) inhibitors, CYP3A substrates with narrow therapeutic indices, or strong CYP3A inducers, which cannot be stopped within at least 5 half-lives, but not fewer than 10 days, before randomization
- Consumption of grapefruit or grapefruit juice, Seville orange or Seville orange containing products (e.g., marmalade), or xanthine containing products within 48 hours before dosing with study drug
- Prescription or over the counter (OTC) medications within 14 days before the first dose of study drug unless specifically allowed by protocol. (Permitted medications include multivitamins, paracetamol [up to 2g per day], and/or treatments for chronic stable diseases, provided the drug and dose have been stable for ≥30 days prior to administration of study drug)
- Has received another investigational drug (defined as a small molecule or biologic compound which has not been approved for marketing) within 30 days of the administration of study drug in this study or within 5 half-lives of the prior study drug, whichever is longer
- Positive test result for alcohol or drugs of abuse at Screening or Check-in
- Participated in strenuous activity or contact sports within 24 hours before the infusion of study drug or while confined in the clinical site
- History of severe or ongoing allergy/hypersensitivity to any drug or biologic therapeutic agent
- Involvement with any previous Sponsor's or study site employee or their close relatives (e.g., spouse, parents, siblings, or children whether biological or legally adopted)
- Previously received PB2452 or had been randomized to receive study drug in an earlier cohort for this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2A, Randomized, Double-blind, Placebo-controlled, Single Dose, Sequential Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PB2452 With Ticagrelor Pretreatment in Older and Elderly Subjects and With High-Dose Ticagrelor Pretreatment in Healthy Younger Subjects
This is a Phase 2A, randomized, double-blind, placebo-controlled, single dose, sequential group study to evaluate the safety, tolerability, PK, and PD of PB2452 vs matching placebo with ticagrelor (with or without acetylsalicylic acid (ASA)) pretreatment when various dose levels and administration regimens are administered to healthy younger (ages 18 to 50), older (ages 50 to 64 years) and elderly (ages 65 to 80 years) male and female subjects.
Up to 5 dose levels and/or administration regimens will be evaluated in up to 5 cohorts. Each cohort will include approximately 8 to 12 subjects randomized in a 3:1 ratio (PB2452:placebo).
Read the detailed description
The study will consist of a Screening period, a Check-in day and Pretreatment Period, an on-site Randomization/Treatment day, 3 days on-site for treatment and safety monitoring, a Follow-up Visit (Day 7), and a Final Follow-up visit (Day 28). Seven days prior to Randomization, subjects in Cohorts 1 and 2 will be administered acetylsalicylic acid (ASA) 81 mg orally once daily (QD) until the final dose on the morning of Day 1 before receiving study drug. A ticagrelor 180 mg oral dose will be administered on the morning of Day -2 followed by either 90 mg or 180 mg every 12 hours (BID) until the 5th dose has been administered on the morning of Day 1.
On Day 1, subjects who meet all the inclusion criteria and none of the exclusion criteria will be randomized in a ratio 3:1 (PB2452:placebo), to receive an IV dose of PB2452 or placebo 2 hours following the 5th ticagrelor dose. Subjects may be discharged from the clinical site between Days 3 and 7 inclusive and will return for a Follow-up visit on Day 7, if already discharged, and on Day 28 (±2 days).
- 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 - 24 hour infusion
Placebo - Sodium ChlorideDrug
30 minute - 24 hour infusion
Ticagrelor Oral Tablet - Pre-TreatmentDrug
Ticagrelor 180 mg + 90 mg BID for 5 doses prior to PB2452 or Placebo
Ticagrelor Oral Tablet - Pre-Treatment and Post-TreatmentDrug
Ticagrelor 180 mg + 90 mg BID for 5 doses prior to PB2452 or Placebo and Ticagrelor 180 mg 24 hours following PB2452 or Placebo
Ticagrelor Oral Tablet - Pre-TreatmentDrug
Ticagrelor 180 mg BID for 5 doses prior to PB2452 or Placebo
PB2452 InfusionDrug
30 minute - 16 hour infusion
Placebo - Sodium ChlorideDrug
Placebo - Sodium Chloride
| Study group | Role | What they receive |
|---|---|---|
| 1: 18 g 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: Ticagrelor Oral Tablet - Pre-Treatment; Drug: PB2452 Infusion; Drug: Placebo - Sodium Chloride |
| 2: 18 g or greater 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: Ticagrelor Oral Tablet - Pre-Treatment; Drug: PB2452 Infusion; Drug: Placebo - Sodium Chloride |
| 3: 18 g or greater PB2452 or Placebo (Ticagrelor Pre-Trx) | Experimental | PB2452 Infusion or Placebo - Sodium Chloride with Ticagrelor Oral Tablet: 180 mg BID for a total of 5 doses Receives: Drug: PB2452 Infusion; Drug: Placebo - Sodium Chloride; Drug: Ticagrelor Oral Tablet - Pre-Treatment |
| 4: 18 g or greater PB2452 or Placebo (Ticagrelor Pre-Trx) | Experimental | PB2452 Infusion or Placebo - Sodium Chloride With Ticagrelor Oral Tablet: 180 mg BID for a total of 5 doses Receives: Drug: PB2452 Infusion; Drug: Placebo - Sodium Chloride; Drug: Ticagrelor Oral Tablet - Pre-Treatment |
| 5: 18 g or greater PB2452 or Placebo (Ticagrelor Pre-Trx) | Experimental | PB2452 Infusion or Placebo - Sodium Chloride with Ticagrelor Oral Tablet: 180 mg BID for a total of 5 doses Receives: Drug: PB2452 Infusion; Drug: Placebo - Sodium Chloride; Drug: Ticagrelor Oral Tablet - Pre-Treatment; Drug: Ticagrelor Oral Tablet - Pre-Treatment and Post-Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number Of Participants With Treatment-emergent Adverse Events (TEAEs) And Serious Adverse Events (SAEs)
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. A TEAE is defined as any AE not present before exposure to study drug or any AE already present that worsens in intensity or frequency after exposure to study drug. An SAE/suspected unexpected serious adverse reaction if, in the view of either the investigator or Sponsor, it results in any of the following outcomes: death, life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or congenital anomaly or birth defect. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Measured: Day -3 up to Day 28
Number of Participants With Clinical Laboratory Abnormalities
Number of participants with clinically significant abnormal laboratory findings for hematology, coagulation, serum chemistry, and urinalysis.
Measured: Day -45 up to Day 28
Mean Diastolic Blood Pressure at Baseline
Measured: Baseline
Percent Change In Diastolic Blood Pressure From Baseline To Day 28
Diastolic blood pressure measurements were measured at specific time points.
Measured: Day 1 (10, 20, 30, 45, and 60 minutes post-dose), Day 2, Day 3, Day 7, and Day 28
Mean Systolic Blood Pressure at Baseline
Measured: Baseline
Percent Change In Systolic Blood Pressure From Baseline To Day 28
Systolic blood pressure measurements were measured at specific time points.
Measured: Day 1 (10, 20, 30, 45, and 60 minutes post-dose), Day 2, Day 3, Day 7, and Day 28
Mean Oral Body Temperature at Baseline
Measured: Baseline
Percent Change In Oral Body Temperature From Baseline To Day 28
Body temperature measurements were measured at specific time points.
Measured: Day 1 (45 and 60 minutes post-dose), Day 2, Day 3, Day 7, and Day 28
Mean Respiratory Rate at Baseline
Measured: Baseline
Percent Change In Respiratory Rate From Baseline To Day 28
Respiratory rate measurements were measured at specific time points.
Measured: Day 1 (45 and 60 minutes post-dose), Day 2, Day 3, Day 7, and Day 28
Mean Heart Rate at Baseline
Measured: Baseline
Percent Change In Heart Rate From Baseline To Day 28
Heart rate measurements were measured at specific time points.
Measured: Baseline, Day 1 (10, 20, 30, 45, and 60 minutes post-dose), Day 2, Day 3, Day 7, and Day 28
Incidence Of Clinically Significant 12-Lead Electrocardiogram (ECG) Findings
Number of participants per cohort with clinically significant ECG findings.
Measured: Up to Day 28
Participants Experiencing Anti-drug Antibodies (ADAs)
Number of participants who developed ADAs to PB2452.
Measured: Day -3, Day 1, Day 7, and Day 28
Number of Participants With Adverse Events During Physical Examination
Participants with adverse events noted during physical exam between baseline and end of study.
Measured: Baseline through Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start16 Apr 2019
- Primary completion9 Oct 2019
- Study completion9 Oct 2019
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- SFJ Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- LuAnn Bundrant, MD, Principal investigator, PPD Development, LP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03928353
- Sponsor's protocol ID
- PB2452-PT-CL-0002
- Status last verified
- Apr 2024
- First submitted
- 24 Apr 2019
- Last updated
- 1 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2A, Randomized, Double-blind, Placebo-controlled, Single Dose, Sequential Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PB2452 With Ticagrelor Pretreatment in Older and Elderly Subjects and With High-Dose Ticagrelor Pretreatment in Healthy Younger Subjects
- ClinicalTrials.gov ID
- NCT03928353
- Acronym / sponsor ID
- PB2452-PT-CL-0002
- Conditions
- Healthy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- SFJ Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 9 Oct 2019 (actual)
- Study completion
- 9 Oct 2019 (actual)
- First posted
- 26 Apr 2019 (actual)
- Results
- Posted 1 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2A, randomized, double-blind, placebo-controlled, single dose, sequential group study to evaluate the safety, tolerability, PK, and PD of PB2452 vs matching placebo with ticagrelor (with or without acetylsalicylic acid (ASA)) pretreatment when various dose levels and administration regimens are administered to healthy younger (ages 18 to 50), older (ages 50 to 64 years) and elderly (ages 65 to 80 years) male and female subjects.
Up to 5 dose levels and/or administration regimens will be evaluated in up to 5 cohorts. Each cohort will include approximately 8 to 12 subjects randomized in a 3:1 ratio (PB2452:placebo).
Detailed description
The study will consist of a Screening period, a Check-in day and Pretreatment Period, an on-site Randomization/Treatment day, 3 days on-site for treatment and safety monitoring, a Follow-up Visit (Day 7), and a Final Follow-up visit (Day 28). Seven days prior to Randomization, subjects in Cohorts 1 and 2 will be administered acetylsalicylic acid (ASA) 81 mg orally once daily (QD) until the final dose on the morning of Day 1 before receiving study drug. A ticagrelor 180 mg oral dose will be administered on the morning of Day -2 followed by either 90 mg or 180 mg every 12 hours (BID) until the 5th dose has been administered on the morning of Day 1.
On Day 1, subjects who meet all the inclusion criteria and none of the exclusion criteria will be randomized in a ratio 3:1 (PB2452:placebo), to receive an IV dose of PB2452 or placebo 2 hours following the 5th ticagrelor dose. Subjects may be discharged from the clinical site between Days 3 and 7 inclusive and will return for a Follow-up visit on Day 7, if already discharged, and on Day 28 (±2 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1: 18 g PB2452 or Placebo (Ticagrelor Pre-Trx) | Experimental | Drug: Ticagrelor Oral Tablet - Pre-Treatment, 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 |
| 2: 18 g or greater PB2452 or Placebo (Ticagrelor Pre-Trx) | Experimental | Drug: Ticagrelor Oral Tablet - Pre-Treatment, 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 |
| 3: 18 g or greater 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 BID for a total of 5 doses |
| 4: 18 g or greater 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 BID for a total of 5 doses |
| 5: 18 g or greater PB2452 or Placebo (Ticagrelor Pre-Trx) | Experimental | Drug: PB2452 Infusion, Drug: Placebo - Sodium Chloride, Drug: Ticagrelor Oral Tablet - Pre-Treatment, Drug: Ticagrelor Oral Tablet - Pre-Treatment and Post-TreatmentPB2452 Infusion or Placebo - Sodium Chloride with Ticagrelor Oral Tablet: 180 mg BID for a total of 5 doses |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- The subject provides written informed consent and agrees to comply with all protocol requirements.
- The subject is male or female between 18 and 80 years of age, inclusive (50 to 80 years for Cohorts 1-2, 18 to 50 years for Cohorts 3-5).
- The subject has a body mass index (BMI) 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. Older and elderly subjects with chronic, stable, and well-controlled medical conditions are eligible provided they meet all other inclusion/exclusion criteria. Some examples of stable and well-controlled medical conditions include but are not limited to:
- Specific inclusionary laboratory values at Screening and Check-in require:
Key exclusion criteria (31 listed)
- Concern the subject may be unable 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
- History of any acute or chronic medical disorder expected to decrease the life expectancy of the subject
- History or presence of gastrointestinal (GI), hepatic (with the exception of Gilbert's syndrome), or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
- Significant renal insufficiency, as indicated by estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 according to the Modification of Diet in Renal Disease (MDRD) equation
- Any clinically significant (CS) acute illness, medical/surgical procedure, or trauma within 4 weeks of administration of study drug or any planned surgical procedure that will occur during the study (from Screening through the Day 28 [±2 days] Follow-up visit)
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 - 24 hour infusion | Drug | 3: 18 g or greater PB2452 or Placebo (Ticagrelor Pre-Trx), 4: 18 g or greater PB2452 or Placebo (Ticagrelor Pre-Trx), 5: 18 g or greater PB2452 or Placebo (Ticagrelor Pre-Trx) |
| Placebo - Sodium Chloride30 minute - 24 hour infusion | Drug | 3: 18 g or greater PB2452 or Placebo (Ticagrelor Pre-Trx), 4: 18 g or greater PB2452 or Placebo (Ticagrelor Pre-Trx), 5: 18 g or greater PB2452 or Placebo (Ticagrelor Pre-Trx) |
| Ticagrelor Oral Tablet - Pre-TreatmentTicagrelor 180 mg + 90 mg BID for 5 doses prior to PB2452 or Placebo | Drug | 1: 18 g PB2452 or Placebo (Ticagrelor Pre-Trx), 2: 18 g or greater PB2452 or Placebo (Ticagrelor Pre-Trx), 5: 18 g or greater PB2452 or Placebo (Ticagrelor Pre-Trx) |
| Ticagrelor Oral Tablet - Pre-Treatment and Post-TreatmentTicagrelor 180 mg + 90 mg BID for 5 doses prior to PB2452 or Placebo and Ticagrelor 180 mg 24 hours following PB2452 or Placebo | Drug | 5: 18 g or greater PB2452 or Placebo (Ticagrelor Pre-Trx) |
| Ticagrelor Oral Tablet - Pre-TreatmentTicagrelor 180 mg BID for 5 doses prior to PB2452 or Placebo | Drug | 3: 18 g or greater PB2452 or Placebo (Ticagrelor Pre-Trx), 4: 18 g or greater PB2452 or Placebo (Ticagrelor Pre-Trx), 5: 18 g or greater PB2452 or Placebo (Ticagrelor Pre-Trx) |
| PB2452 Infusion30 minute - 16 hour infusion | Drug | 1: 18 g PB2452 or Placebo (Ticagrelor Pre-Trx), 2: 18 g or greater PB2452 or Placebo (Ticagrelor Pre-Trx) |
| Placebo - Sodium ChloridePlacebo - Sodium Chloride | Drug | 1: 18 g PB2452 or Placebo (Ticagrelor Pre-Trx), 2: 18 g or greater PB2452 or Placebo (Ticagrelor Pre-Trx) |
Primary outcome
Number Of Participants With Treatment-emergent Adverse Events (TEAEs) And Serious Adverse Events (SAEs)
Time frame: Day -3 up to Day 28
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug-related. A TEAE is defined as any AE not present before exposure to study drug or any AE already present that worsens in intensity or frequency after exposure to study drug. An SAE/suspected unexpected serious adverse reaction if, in the view of either the investigator or Sponsor, it results in any of the following outcomes: death, life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or congenital anomaly or birth defect. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Number of Participants With Clinical Laboratory Abnormalities
Time frame: Day -45 up to Day 28
Number of participants with clinically significant abnormal laboratory findings for hematology, coagulation, serum chemistry, and urinalysis.
Mean Diastolic Blood Pressure at Baseline
Time frame: Baseline
Percent Change In Diastolic Blood Pressure From Baseline To Day 28
Time frame: Day 1 (10, 20, 30, 45, and 60 minutes post-dose), Day 2, Day 3, Day 7, and Day 28
Diastolic blood pressure measurements were measured at specific time points.
Mean Systolic Blood Pressure at Baseline
Time frame: Baseline
Percent Change In Systolic Blood Pressure From Baseline To Day 28
Time frame: Day 1 (10, 20, 30, 45, and 60 minutes post-dose), Day 2, Day 3, Day 7, and Day 28
Systolic blood pressure measurements were measured at specific time points.
Mean Oral Body Temperature at Baseline
Time frame: Baseline
Percent Change In Oral Body Temperature From Baseline To Day 28
Time frame: Day 1 (45 and 60 minutes post-dose), Day 2, Day 3, Day 7, and Day 28
Body temperature measurements were measured at specific time points.
Mean Respiratory Rate at Baseline
Time frame: Baseline
Percent Change In Respiratory Rate From Baseline To Day 28
Time frame: Day 1 (45 and 60 minutes post-dose), Day 2, Day 3, Day 7, and Day 28
Respiratory rate measurements were measured at specific time points.
Mean Heart Rate at Baseline
Time frame: Baseline
Percent Change In Heart Rate From Baseline To Day 28
Time frame: Baseline, Day 1 (10, 20, 30, 45, and 60 minutes post-dose), Day 2, Day 3, Day 7, and Day 28
Heart rate measurements were measured at specific time points.
Incidence Of Clinically Significant 12-Lead Electrocardiogram (ECG) Findings
Time frame: Up to Day 28
Number of participants per cohort with clinically significant ECG findings.
Participants Experiencing Anti-drug Antibodies (ADAs)
Time frame: Day -3, Day 1, Day 7, and Day 28
Number of participants who developed ADAs to PB2452.
Number of Participants With Adverse Events During Physical Examination
Time frame: Baseline through Day 28
Participants with adverse events noted during physical exam between baseline and end of study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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?
A Phase 2 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.
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 19 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 1 May 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 1 May 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 Treatment-emergent Adverse Events (TEAEs) And Serious Adverse Events (SAEs) (time frame: Day -3 up to Day 28). The study lists 15 primary outcomes in all. 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 1 May 2024.