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HealthyPhase 1NCT05162131

Study to Evaluate the Safety, Tolerability, PK, and PD of PB2452 With and Without Ticagrelor Pretreatment in Chinese Healthy Volunteers

A Phase 1 study of Healthy, run by SFJ Pharmaceuticals, Inc. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 20 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
34 participants
Where
1 siteChina
Study dates
25 Dec 2021to 30 Dec 2022
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 20 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • The subject is born in China to parents and grandparents of Chinese descent. Have not resided more than 5 years outside of China at the time of consent.
  • The subject is male or female 20 ≤ age ≤ 64.
  • The subject has a body mass index 18 ≤ BMI ≤35 kg/m2 and a weight of ≥45 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 aminotransaminase (AST), alanine aminotransaminase (ALT), total serum bilirubin and alkaline phosphatase levels without clinically significant abnormality per investigator's discretion
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  • White blood cell (WBC) count, platelet count, hemoglobin level without clinically significant abnormality per investigator's discretion
  • Thyroid stimulating hormone (TSH) level without clinically significant abnormality per investigator's discretion at screening
  • Prothrombin time (PT) and partial thromboplastin time (PTT) level without clinically significant abnormality per investigator's discretion
  • 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 (hormonal contraceptives [i.e., oral, implantable, patch, or injectable contraceptives, hormone-containing intrauterine device that has been in place for at least 2 months prior to screening] in combination with a barrier method [i.e., condoms, sponge, diaphragm, or cervical cap with spermicidal gels or cream]) from 30 days before study drug administration through the end of the study. Double barrier method of condom and spermicide without hormonal contraceptives, or confirmation of sexual abstinence is acceptable, as well as vasectomy for male subjects or male partners of female subjects. Women are considered not to be of childbearing potential if they have fulfilled one of the following criteria: documentation of irreversible surgical sterilization (i.e., 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 (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 to refrain from donating sperm for at least 7 days prior to the dose of study drug and 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 (i.e., estimated glomerular filtration rate <60 ml/min/1.73m2), or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
  • Specific exclusionary criteria for ECG parameters at screening or check-in are any of the following:
  • Prolonged Fridericia-corrected QT interval (QTcF) >450 milliseconds (msec), shortened QTcF <340 msec, or pause >3 seconds, or family history of long QT syndrome
  • Prolonged PR (PQ) interval >240 msec, intermittent second- or third-degree atrioventricular (AV) block or AV dissociation, or shortened PR interval <120 msec
  • Incomplete, full, or intermittent bundle branch block (QRS <110 msec with normal QRS and T wave morphology is acceptable if there is no evidence of left ventricular hypertrophy
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  • 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 (e.g., 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 anticoagulants including low molecular-weight heparin, or other antiplatelet agents
  • 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.
  • 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.
  • Any prescription or over-the-counter medications (except paracetamol [up to 2 g per day] or as indicated per protocol e.g. for birth control), 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 (e.g., marmalade), or alcohol-, or xanthine-containing products within 48 hours before dosing with study drug.
  • The subject is participating in any other study within 30 days of the administration of study drug in this study.
  • The subject 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 administration of study drug in this study or 5 half-lives of the experimental medication, whichever is longer.
  • The subject has involvement with any sponsor or study site employee or their close relatives (e.g., spouse, parents, siblings, or children whether biological or legally adopted).
  • The subject has previously received PB2452 or had been randomized to receive study drug in an earlier cohort for this study.
  • The subject is a smoker or has used nicotine or nicotine-containing products (e.g., snuff, nicotine patch, nicotine chewing gum, e- cigarettes, mock cigarettes, or inhalers) within 3 months before the infusion of study drug.
  • The subject has a known or suspected history of alcohol/drug abuse or has a positive test result for drugs of abuse, alcohol, or cotinine at screening or check-in.
  • The subject has been involved in strenuous activity or contact sports within 48 hours before the admission 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 infusion 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.

China1 site

  • Beijing Friendship Hospital

    Tongzhou, Beijing Municipality

Other trials in China

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 PB2452 (Bentracimab) With and Without Ticagrelor Pretreatment in Chinese Healthy Volunteers

This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose, sequential group study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PB2452 (Bentracimab) with and without ticagrelor pretreatment when administered to Chinese healthy male and female subjects.

Up to 6 dose levels will be evaluated. This study will have 5 cohorts and a total of 40 subjects with 8 healthy subjects per cohort. Cohort 1 will be split into 3 parts, Cohort 1-a, 1-b and 1-c. The starting dose of PB2452 will be 100 mg and the planned doses for subsequent parts or cohorts are 300, 1000, 3000, 9000, and 18000 mg.

Read the detailed description

The study will consist of a screening period (Days -28 to -4), check-in/pretreatment (Day -3 to -1), an in-house treatment period (Days 1 through 4), and follow-up visits (Days 7 and 28 (+2 days)). Subjects will receive an IV dose of study drug on Day 1.

On Day 1, subjects who meet all of the inclusion criteria and none of the exclusion criteria will be assigned to treatment before dosing. For Cohorts 1-c and 2 to 5, subjects will be randomly assigned to receive PB2452 or placebo in a ratio of 3:1.

Conditions
Healthy
Being tested
Bentracimab (PB2452) 100 mg or Placebo, Bentracimab (PB2452) 300 mg or Placebo, Bentracimab (PB2452) 1000 mg or Placebo, Bentracimab (PB2452) 1000 mg or Placebo (With Ticagrelor Pre-Treatment), Bentracimab (PB2452) 3000 mg or Placebo (With Ticagrelor Pre-Treatment)
Keywords
Ticagrelor, Platelet Aggregation Inhibitors, P2Y12 Receptor Antagonists

What participants receive

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

  • Bentracimab (PB2452) 100 mg or PlaceboDrug

    Experiment 1-a: 100 mg Bentracimab (PB2452) (no Placebo, no Ticagrelor)

    Drug: PB2452 infusion 30 minute - 12-hour infusion

  • Bentracimab (PB2452) 300 mg or PlaceboDrug

    Experiment 1-b: 300 mg Bentracimab (PB2452) (no Placebo, no Ticagrelor)

    Drug: PB2452 infusion 30 minute - 12-hour infusion

  • Bentracimab (PB2452) 1000 mg or PlaceboDrug

    Experiment 1-c: 1000 mg Bentracimab (PB2452) or Placebo (no Ticagrelor)

    Drug: PB2452 Infusion 30 minute - 12-hour infusion

    Drug: Placebo - Sodium Chloride 30 minute - 12-hour infusion

  • Bentracimab (PB2452) 1000 mg or Placebo (With Ticagrelor Pre-Treatment)Drug

    Experiment 2: 1000 mg Bentracimab (PB2452) or Placebo (Ticagrelor Pre-treatment)

    Drug: PB2452 infusion 30 minute - 12-hour infusion

    Drug: Placebo - Sodium Chloride 30 minute - 12-hour infusion

    Drug: Ticagrelor Oral Tablet - Pre-treatment Ticagrelor 180 mg + 90 mg bid for 5 doses prior to PB2452 or Placebo

  • Bentracimab (PB2452) 3000 mg or Placebo (With Ticagrelor Pre-Treatment)Drug

    Experiment 3: 3000 mg Bentracimab (PB2452) or Placebo (Ticagrelor Pre-treatment)

    Drug: PB2452 infusion 30 minute - 12-hour infusion

    Drug: Placebo - Sodium Chloride 30 minute - 12-hour infusion

    Drug: Ticagrelor Oral Tablet - Pre-treatment Ticagrelor 180 mg + 90 mg bid for 5 doses prior to PB2452 or Placebo

  • Bentracimab (PB2452) 9000 mg or Placebo (With Ticagrelor Pre-Treatment)Drug

    Experiment 4: 9000 mg Bentracimab (PB2452) or Placebo (Ticagrelor Pre-treatment)

    Drug: PB2452 infusion 30 minute - 12-hour infusion

    Drug: Placebo - Sodium Chloride 30 minute - 12-hour infusion

    Drug: Ticagrelor Oral Tablet - Pre-treatment Ticagrelor 180 mg + 90 mg bid for 5 doses prior to PB2452 or Placebo

  • Bentracimab (PB2452) 18000 mg or Placebo (With Ticagrelor Pre-Treatment)Drug

    Experiment 5: 18000 mg Bentracimab (PB2452) or Placebo (Ticagrelor Pre-treatment)

    Drug: PB2452 infusion 30 minute - 12-hour infusion

    Drug: Placebo - Sodium Chloride 30 minute - 12-hour infusion

    Drug: Ticagrelor Oral Tablet - Pre-treatment Ticagrelor 180 mg + 90 mg bid for 5 doses prior to PB2452 or Placebo

Study groups in NCT05162131
Study groupRoleWhat they receive
1-a: 100 mg Bentracimab (PB2452) (no Placebo, no Ticagrelor)ExperimentalPB2452 Infusion
Receives: Drug: Bentracimab (PB2452) 100 mg or Placebo
1-b: 300 mg Bentracimab (PB2452) (no Placebo, no Ticagrelor)ExperimentalPB2452 Infusion
Receives: Drug: Bentracimab (PB2452) 300 mg or Placebo
1-c: 1000 mg Bentracimab (PB2452) or Placebo (no Ticagrelor)ExperimentalPB2452 Infusion or Placebo - Sodium Chloride
Receives: Drug: Bentracimab (PB2452) 1000 mg or Placebo
2: 1000 mg Bentracimab (PB2452) or Placebo (Ticagrelor Pre-treatment)ExperimentalPB2452 Infusion or Placebo - Sodium Chloride with Ticagrelor Oral Tablet: 180 mg + 90 mg bid for a total of 5 doses
Receives: Drug: Bentracimab (PB2452) 1000 mg or Placebo (With Ticagrelor Pre-Treatment)
3: 3000 mg Bentracimab (PB2452) or Placebo (Ticagrelor Pre-treatment)ExperimentalPB2452 Infusion or Placebo - Sodium Chloride with Ticagrelor Oral Tablet: 180 mg + 90 mg bid for a total of 5 doses
Receives: Drug: Bentracimab (PB2452) 3000 mg or Placebo (With Ticagrelor Pre-Treatment)
4: 9000 mg Bentracimab (PB2452) or Placebo (Ticagrelor Pre-treatment)ExperimentalPB2452 Infusion or Placebo - Sodium Chloride with Ticagrelor Oral Tablet: 180 mg + 90 mg bid for a total of 5 doses
Receives: Drug: Bentracimab (PB2452) 9000 mg or Placebo (With Ticagrelor Pre-Treatment)
5: 18000 mg Bentracimab (PB2452) or Placebo (Ticagrelor Pre-treatment)ExperimentalPB2452 Infusion or Placebo - Sodium Chloride with Ticagrelor Oral Tablet: 180 mg + 90 mg bid for a total of 5 doses
Receives: Drug: Bentracimab (PB2452) 18000 mg or Placebo (With Ticagrelor Pre-Treatment)

What is being measured

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

  1. Incidence and severity of AEs

    Measured: Time Frame: 60 days - Starting up to 28 days prior to dosing

  2. Incidence of Clinical Laboratory Abnormalities

    Measured: 30 Day - Starting day of dosing

  3. Vital Sign Measurements - Changes in Diastolic Blood Pressure

    Measured: 60 days - Starting up to 28 days prior to dosing

  4. Vital Sign Measurements - Changes in Systolic Blood Pressure

    Measured: 60 days - Starting up to 28 days prior to dosing

  5. Vital Sign Measurements - Changes in Axillary Temperature

    Measured: 60 days - Starting up to 28 days prior to dosing

  6. Vital Sign Measurements - Changes in Respiratory Rate

    Measured: 60 days - Starting up to 28 days prior to dosing

  7. Vital Sign Measurements - Changes in Heart Rate

    Measured: 60 days - Starting up to 28 days prior to dosing

  8. 12-Lead ECG - Incidence of clinically significant findings

    Measured: 60 days - Starting up to 28 days prior to dosing

  9. Cardiac Telemetry Monitoring - Incidence of clinically significant findings

    Measured: 3 Days - Starting day 1 day prior to dosing up to 2 days after dosing

  10. Physical examination - Incidence of clinically significant findings

    Measured: 3 Days - Starting day 1 day prior to dosing up to 2 days after dosing

  11. Immunogenicity

    Incidence of Immunogenicity

    Measured: 60 days

Secondary outcomes (74)

  1. PB2452 Pharmacokinetic profile - (AUC) (Cohort 1-4)

    Area under the plasma concentration versus time curve (AUC)

    Measured: -10 minutes,0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours and 7 days

  2. PB2452 Pharmacokinetic profile - (AUC) (Cohort 5)

    Area under the plasma concentration versus time curve (AUC)

    Measured: -10 minutes,10 minutes, 30 minutes, 1, 2, 4, 8, 12, 16, 18, 20, 24, 28, 32, 36, 48, 72 hours and 7 days

  3. PB2452 Pharmacokinetic profile - (AUC0-t) (Cohort 1-4)

    Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration (AUC0-t)

    Measured: -10 minutes,0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours and 7 days

  4. PB2452 Pharmacokinetic profile - (AUC0-t) (Cohort 5)

    Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration (AUC0-t)

    Measured: -10 minutes,10 minutes, 30 minutes, 1, 2, 4, 8, 12, 16, 18, 20, 24, 28, 32, 36, 48, 72 hours and 7 days

  5. PB2452 Pharmacokinetic profile - Cmax (Cohorts 1-4)

    Observed maximum plasma concentration

    Measured: -10 minutes,0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours and 7 days

  6. PB2452 Pharmacokinetic profile - Cmax (Cohort 5)

    Observed maximum plasma concentration

    Measured: -10 minutes,10 minutes, 30 minutes, 1, 2, 4, 8, 12, 16, 18, 20, 24, 28, 32, 36, 48, 72 hours and 7 days

  7. PB2452 Pharmacokinetic profile - Tmax (Cohorts 1-4)

    Time to reach the observed maximum plasma concentration

    Measured: -10 minutes,0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours and 7 days

  8. PB2452 Pharmacokinetic profile - Tmax (Cohort 5)

    Time to reach the observed maximum plasma concentration

    Measured: -10 minutes,10 minutes, 30 minutes, 1, 2, 4, 8, 12, 16, 18, 20, 24, 28, 32, 36, 48, 72 hours and 7 days

  9. PB2452 Pharmacokinetic profile - AUC(0-inf) (Cohorts 1-4)

    AUC from time 0 extrapolated to infinity

    Measured: -10 minutes,0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours and 7 days

  10. PB2452 Pharmacokinetic profile - AUC(0-inf) (Cohort 5)

    AUC from time 0 extrapolated to infinity

    Measured: -10 minutes, 10 minutes, 30 minutes, 1, 2, 4, 8, 12, 16, 18, 20, 24, 28, 32, 36, 48, 72 hours and 7 days

  11. PB2452 Pharmacokinetic profile - t½ (Cohorts 1-4)

    Terminal elimination half-life

    Measured: -10 minutes,0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours and 7 days

  12. PB2452 Pharmacokinetic profile - t½ (Cohort 5)

    Terminal elimination half-life

    Measured: -10 minutes,10 minutes, 30 minutes, 1, 2, 4, 8, 12, 16, 18, 20, 24, 28, 32, 36, 48, 72 hours and 7 days

  13. PB2452 Pharmacokinetic profile - CL (Cohorts 1-4)

    Apparent clearance

    Measured: -10 minutes,0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours and 7 days

  14. PB2452 Pharmacokinetic profile - CL (Cohort 5)

    Apparent clearance

    Measured: -10 minutes,10 minutes, 30 minutes, 1, 2, 4, 8, 12, 16, 18, 20, 24, 28, 32, 36, 48, 72 hours and 7 days

  15. Ticagrelor and Ticagrelor Active Metabolite (TAM) Pharmacokinetic profile - Cmax (Cohorts 2-4)

    Observed maximum plasma concentration

    Measured: -10 minutes,0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours

  16. Ticagrelor and Ticagrelor Active Metabolite (TAM) Pharmacokinetic profile - Cmax (Cohort 5)

    Observed maximum plasma concentration

    Measured: -10 minutes,10 minutes, 30 minutes, 1, 2, 4, 8, 12, 16, 18, 20, 24, 28, 32, 36, 48 hours

  17. Ticagrelor and Ticagrelor Active Metabolite (TAM) Pharmacokinetic profile - Tmax (Cohorts 2-4)

    Time to reach the observed maximum plasma concentration

    Measured: -10 minutes,0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours

  18. Ticagrelor and Ticagrelor Active Metabolite (TAM) Pharmacokinetic profile - Tmax (Cohort 5)

    Time to reach the observed maximum plasma concentration

    Measured: -10 minutes,10 minutes, 30 minutes, 1, 2, 4, 8, 12, 16, 18, 20, 24, 28, 32, 36, 48 hours

  19. Ticagrelor and Ticagrelor Active Metabolite (TAM) Pharmacokinetic profile - AUC(0-12) (Cohorts 2-4)

    AUC from time 0 to 12 hours after dosing

    Measured: -10 minutes,0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours

  20. Ticagrelor and Ticagrelor Active Metabolite (TAM) Pharmacokinetic profile - AUC(0-12) (Cohort 5)

    AUC from time 0 to 12 hours after dosing

    Measured: -10 minutes,10 minutes, 30 minutes, 1, 2, 4, 8, 12, 16, 18, 20, 24, 28, 32, 36, 48 hours

  21. Ticagrelor and Ticagrelor Active Metabolite (TAM) Pharmacokinetic profile - AUC(0-24) (Cohorts 2-4)

    AUC from time 0 to 24 hours after dosing

    Measured: -10 minutes,0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours

  22. Ticagrelor and Ticagrelor Active Metabolite (TAM) Pharmacokinetic profile - AUC(0-24) (Cohort 5)

    AUC from time 0 to 24 hours after dosing

    Measured: -10 minutes,10 minutes, 30 minutes, 1, 2, 4, 8, 12, 16, 18, 20, 24, 28, 32, 36, 48 hours

  23. Ticagrelor and Ticagrelor Active Metabolite (TAM) Pharmacokinetic profile - AUC(0-48) (Cohorts 2-4)

    AUC from time 0 to 48 hours after dosing

    Measured: -10 minutes,0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours

  24. Ticagrelor and Ticagrelor Active Metabolite (TAM) Pharmacokinetic profile - AUC(0-48) (Cohort 5)

    AUC from time 0 to 48 hours after dosing

    Measured: -10 minutes,10 minutes, 30 minutes, 1, 2, 4, 8, 12, 16, 18, 20, 24, 28, 32, 36, 48 hours

  25. Ticagrelor and Ticagrelor Active Metabolite (TAM) Pharmacokinetic profile - (Clast) AUC(0-t) (Cohorts 2-4)

    AUC from time 0 to the time of last quantifiable concentration

    Measured: -10 minutes,0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours

  26. Ticagrelor and Ticagrelor Active Metabolite (TAM) Pharmacokinetic profile - (Clast) AUC(0-t) (Cohort 5)

    AUC from time 0 to the time of last quantifiable concentration

    Measured: -10 minutes,10 minutes, 30 minutes, 1, 2, 4, 8, 12, 16, 18, 20, 24, 28, 32, 36, 48 hours

  27. Ticagrelor and Ticagrelor Active Metabolite (TAM) Pharmacokinetic profile - AUC0-inf (Cohorts 2-4)

    AUC from time 0 extrapolated to infinity

    Measured: -10 minutes,0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours

  28. Ticagrelor and Ticagrelor Active Metabolite (TAM) Pharmacokinetic profile - AUC0-inf (Cohort 5)

    AUC from time 0 extrapolated to infinity

    Measured: -10 minutes,10 minutes, 30 minutes, 1, 2, 4, 8, 12, 16, 18, 20, 24, 28, 32, 36, 48 hours

  29. Ticagrelor and Ticagrelor Active Metabolite (TAM) Pharmacokinetic profile - t½ (Cohorts 2-4)

    Terminal elimination half-life (if data permit)

    Measured: -10 minutes,0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours

  30. Ticagrelor and Ticagrelor Active Metabolite (TAM) Pharmacokinetic profile - t½ (Cohort 5)

    Terminal elimination half-life

    Measured: -10 minutes,10 minutes, 30 minutes, 1, 2, 4, 8, 12, 16, 18, 20, 24, 28, 32, 36, 48 hours

  31. Urine Pharmacokinetic profile - Ae24 (Cohorts 1-5)

    Total amount of drug excreted in urine at 24 hours after dosing

    Measured: Before dosing (Pre-dose) and 0 to 6, 6 to 12, 12 to 24 hours, and 24 to 48 hours after the initiation of the study drug infusion

  32. Urine Pharmacokinetic profile - Ae48 (Cohorts 1-5)

    Total amount of drug excreted in urine at 48 hours after dosing

    Measured: Before dosing (Pre-dose) and 0 to 6, 6 to 12 , 12 to 24, and 24 to 48 hours after the initiation of the study drug infusion

  33. Urine Pharmacokinetic profile - (Ae t1 - t2 hours) (Cohorts 1-5)

    Total amount of drug excreted in urine at 48 hours after dosing

    Measured: 0 to 6 hours, 6 to 12 hours, 12 to 24 and 24 to 48 hours after the initiation of the study drug infusion

  34. Urine Pharmacokinetic profile - Fe24 (Cohorts 1-5)

    Fraction excreted in urine

    Measured: 1 to 24 hours after dosing

  35. Urine Pharmacokinetic profile - Fe48 (Cohorts 1-5)

    Fraction excreted in urine

    Measured: 1 to 48 hours after dosing

  36. Urine Pharmacokinetic profile - Renal clearance (CLr) for 24 hours (Cohorts 1-5)

    Renal clearance

    Measured: 24 hours after dosing

  37. Urine Pharmacokinetic profile - Renal clearance (CLr) for 48 hours (Cohorts 1-5)

    Renal clearance

    Measured: 48 hours after dosing

  38. Ticagrelor and Ticagrelor Active Metabolite (TAM) Urine Pharmacokinetic profile - Ae24 (Cohorts 2-5)

    Total amount of drug excreted in urine

    Measured: 24 hours after dosing

  39. Ticagrelor and Ticagrelor Active Metabolite (TAM) Urine Pharmacokinetic profile - Ae48 (Cohorts 2-5)

    Total amount of drug excreted in urine

    Measured: 48 hours after dosing

  40. Ticagrelor and Ticagrelor Active Metabolite (TAM) Urine Pharmacokinetic profile - Aet1-t2 (Cohorts 2-5)

    Ae from time t1 to t2 hours

    Measured: 0 to 6, 6 to 12,12 to 24 and 24 to 48 hours

  41. Ticagrelor and Ticagrelor Active Metabolite (TAM) Urine Pharmacokinetic profile - Fe24 (Cohorts 2-5)

    Fraction excreted in urine

    Measured: 1 to 24 hours after dosing

  42. Ticagrelor and Ticagrelor Active Metabolite (TAM) Urine Pharmacokinetic profile - Fe48 (Cohorts 2-5)

    Fraction excreted in urine

    Measured: 1 to 48 hours after dosing

  43. Ticagrelor and Ticagrelor Active Metabolite (TAM) Urine Pharmacokinetic profile - Renal clearance (CLr) for 24 hours (Cohorts 2-5)

    Renal clearance

    Measured: 24 hours after dosing

  44. Ticagrelor and Ticagrelor Active Metabolite (TAM) Urine Pharmacokinetic profile - Renal clearance (CLr) for 48 hours (Cohorts 2-5)

    Renal clearance

    Measured: 48 hours after dosing

  45. Effectiveness of single ascending doses of PB2452 - PRU at each assessment point - P2Y12 Reaction Units with VerifyNow™ PRUTest™ (Cohorts 2-4)

    Measured: Day -2 (60 minutes prior to first ticagrelor dose) and Day 1 (-10 minutes, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours)

  46. Effectiveness of single ascending doses of PB2452 - PRU at each assessment point - P2Y12 Reaction Units with VerifyNow™ PRUTest™ (Cohort 5)

    Measured: Day -2 (60 minutes prior to first ticagrelor dose) and Day 1 (-10 minutes, 10 minutes, 30 minutes, 1, 2, 4, 8, 12, 16, 18, 20, 24, 28, 32, 36 and 48 hours)

  47. Effectiveness of single ascending doses of PB2452 - Percent of baseline in PRU - P2Y12 Reaction Units with VerifyNow™ PRUTest™ (Cohorts 2-4)

    Measured: Day -2 (60 minutes prior to first ticagrelor dose) and Day 1 (-10 minutes, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours)

  48. Percent of baseline in PRU - P2Y12 Reaction Units with VerifyNow™ PRUTest™ (Cohort 5)

    Effectiveness of single ascending doses of PB2452 -

    Measured: Day -2 (60 minutes prior to first ticagrelor dose) and Day 1 (-10 minutes, 10 minutes, 30 minutes, 1, 2, 4, 8, 12, 16, 18, 20, 24, 28, 32, 36 and 48 hours)

  49. Maximal PRU - P2Y12 Reaction Units with VerifyNow™ PRUTest™ (Cohorts 2-4)

    Effectiveness of single ascending doses of PB2452

    Measured: Day -2 (60 minutes prior to first ticagrelor dose) and Day 1 (-10 minutes, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours)

  50. Maximal PRU - P2Y12 Reaction Units with VerifyNow™ PRUTest™ (Cohort 5)

    Effectiveness of single ascending doses of PB2452

    Measured: Day -2 (60 minutes prior to first ticagrelor dose) and Day 1 (-10 minutes, 10 minutes, 30 minutes, 1, 2, 4, 8, 12, 16, 18, 20, 24, 28, 32, 36 and 48 hours)

  51. Time to maximal PRU - P2Y12 Reaction Units with VerifyNow™ PRUTest™ (Cohorts 2-4)

    Effectiveness of single ascending doses of PB2452

    Measured: Day -2 (60 minutes prior to first ticagrelor dose) and Day 1 (-10 minutes, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours)

  52. Time to maximal PRU - P2Y12 Reaction Units with VerifyNow™ PRUTest™ (Cohort 5)

    Effectiveness of single ascending doses of PB2452

    Measured: Day -2 (60 minutes prior to first ticagrelor dose) and Day 1 (-10 minutes, 10 minutes, 30 minutes, 1, 2, 4, 8, 12, 16, 18, 20, 24, 28, 32, 36 and 48 hours)

  53. Time to 200 or greater PRU - P2Y12 Reaction Units with VerifyNow™ PRUTest™ (Cohorts 2-4)

    Effectiveness of single ascending doses of PB2452 -

    Measured: Day -2 (60 minutes prior to first ticagrelor dose) and Day 1 (-10 minutes, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours)

  54. Time to 200 or greater PRU - P2Y12 Reaction Units with VerifyNow™ PRUTest™ (Cohort 5)

    Effectiveness of single ascending doses of PB2452

    Measured: Day -2 (60 minutes prior to first ticagrelor dose) and Day 1 (-10 minutes, 10 minutes, 30 minutes, 1, 2, 4, 8, 12, 16, 18, 20, 24, 28, 32, 36 and 48 hours)

  55. Time to 60% or greater of baseline PRU - P2Y12 Reaction Units with VerifyNow™ PRUTest™ (Cohorts 2-4)

    Effectiveness of single ascending doses of PB2452

    Measured: Day -2 (60 minutes prior to first ticagrelor dose) and Day 1 (-10 minutes, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours)

  56. Time to 60% or greater of baseline PRU - P2Y12 Reaction Units with VerifyNow™ PRUTest™ (Cohort 5)

    Effectiveness of single ascending doses of PB2452

    Measured: Day -2 (60 minutes prior to first ticagrelor dose) and Day 1 (-10 minutes, 10 minutes, 30 minutes, 1, 2, 4, 8, 12, 16, 18, 20, 24, 28, 32, 36 and 48 hours)

  57. Time to 80% or greater of baseline PRU - P2Y12 Reaction Units with VerifyNow™ PRUTest™ (Cohorts 2-4)

    Effectiveness of single ascending doses of PB2452

    Measured: Day -2 (60 minutes prior to first ticagrelor dose) and Day 1 (-10 minutes, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours)

  58. Time to 80% or greater of baseline PRU - P2Y12 Reaction Units with VerifyNow™ PRUTest™ (Cohort 5)

    Effectiveness of single ascending doses of PB2452

    Measured: Day -2 (60 minutes prior to first ticagrelor dose) and Day 1 (-10 minutes, 10 minutes, 30 minutes, 1, 2, 4, 8, 12, 16, 18, 20, 24, 28, 32, 36 and 48 hours)

  59. Time to 90% or greater of baseline PRU - P2Y12 Reaction Units with VerifyNow™ PRUTest™ (Cohorts 2-4)

    Effectiveness of single ascending doses of PB2452

    Measured: Day -2 (60 minutes prior to first ticagrelor dose) and Day 1 (-10 minutes, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours)

  60. Time to 90% or greater of baseline PRU - P2Y12 Reaction Units with VerifyNow™ PRUTest™ (Cohort 5)

    Effectiveness of single ascending doses of PB2452

    Measured: Day -2 (60 minutes prior to first ticagrelor dose) and Day 1 (-10 minutes, 10 minutes, 30 minutes, 1, 2, 4, 8, 12, 16, 18, 20, 24, 28, 32, 36 and 48 hours)

  61. PRI at each assessment point - Vasodilator stimulated response by ELISA (Cohorts 2-4)

    Effectiveness of single ascending doses of PB2452

    Measured: Day -2 (60 minutes prior to first ticagrelor dose) and Day 1 (-10 minutes, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours)

  62. PRI at each assessment point - Vasodilator stimulated response (VASP) by ELISA (Cohort 5)

    Effectiveness of single ascending doses of PB2452

    Measured: Day -2 (60 minutes prior to first ticagrelor dose) and Day 1 (-10 minutes, 10 minutes, 30 minutes, 1, 2, 4, 8, 12, 16, 18, 20, 24, 28, 32, 36 and 48 hours)

  63. Percent of baseline in PRI - Vasodilator stimulated response (VASP) by ELISA (Cohorts 2-4)

    Effectiveness of single ascending doses of PB2452

    Measured: Day -2 (60 minutes prior to first ticagrelor dose) and Day 1 (-10 minutes, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours)

  64. Percent of baseline in PRI - Vasodilator stimulated response (VASP) by ELISA (Cohort 5)

    Effectiveness of single ascending doses of PB2452

    Measured: Day -2 (60 minutes prior to first ticagrelor dose) and Day 1 (-10 minutes, 10 minutes, 30 minutes, 1, 2, 4, 8, 12, 16, 18, 20, 24, 28, 32, 36 and 48 hours)

  65. Maximal PRI - Vasodilator stimulated response (VASP) by ELISA (Cohorts 2-4)

    Effectiveness of single ascending doses of PB2452

    Measured: Day -2 (60 minutes prior to first ticagrelor dose) and Day 1 (-10 minutes, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours)

  66. Maximal PRI - Vasodilator stimulated response (VASP) by ELISA (Cohort 5)

    Effectiveness of single ascending doses of PB2452

    Measured: Day -2 (60 minutes prior to first ticagrelor dose) and Day 1 (-10 minutes, 10 minutes, 30 minutes, 1, 2, 4, 8, 12, 16, 18, 20, 24, 28, 32, 36 and 48 hours)

  67. Time to maximal PRI - Vasodilator stimulated response (VASP) by ELISA (Cohorts 2-4)

    Effectiveness of single ascending doses of PB2452

    Measured: Day -2 (60 minutes prior to first ticagrelor dose) and Day 1 (-10 minutes, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours)

  68. Time to maximal PRI - Vasodilator stimulated response (VASP) by ELISA (Cohort 5)

    Effectiveness of single ascending doses of PB2452

    Measured: Day -2 (60 minutes prior to first ticagrelor dose) and Day 1 (-10 minutes, 10 minutes, 30 minutes, 1, 2, 4, 8, 12, 16, 18, 20, 24, 28, 32, 36 and 48 hours)

  69. Time to 60% or greater of baseline PRI - Vasodilator stimulated response (VASP) by ELISA (Cohorts 2-4)

    Effectiveness of single ascending doses of PB2452

    Measured: Day -2 (60 minutes prior to first ticagrelor dose) and Day 1 (-10 minutes, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours)

  70. Time to 60% or greater of baseline PRI - Vasodilator stimulated response (VASP) by ELISA (Cohort 5)

    Effectiveness of single ascending doses of PB2452

    Measured: Day -2 (60 minutes prior to first ticagrelor dose) and Day 1 (-10 minutes, 10 minutes, 30 minutes, 1, 2, 4, 8, 12, 16, 18, 20, 24, 28, 32, 36 and 48 hours)

  71. Time to 80% or greater of baseline PRI - Vasodilator stimulated response (VASP) by ELISA (Cohort 5)

    Effectiveness of single ascending doses of PB2452

    Measured: Day -2 (60 minutes prior to first ticagrelor dose) and Day 1 (-10 minutes, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours)

  72. Time to 80% or greater of baseline PRI- Vasodilator stimulated response (VASP) by ELISA (Cohort 5)

    Effectiveness of single ascending doses of PB2452

    Measured: Day -2 (60 minutes prior to first ticagrelor dose) and Day 1 (-10 minutes, 10 minutes, 30 minutes, 1, 2, 4, 8, 12, 16, 18, 20, 24, 28, 32, 36 and 48 hours)

  73. Time to 90% or greater of baseline PRI - Vasodilator stimulated response (VASP) by ELISA (Cohorts 2-4)

    Effectiveness of single ascending doses of PB2452

    Measured: Day -2 (60 minutes prior to first ticagrelor dose) and Day 1 (-10 minutes, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hours)

  74. Time to 90% or greater of baseline PRI - Vasodilator stimulated response (VASP) by ELISA (Cohort 5)

    Effectiveness of single ascending doses of PB2452

    Measured: Day -2 (60 minutes prior to first ticagrelor dose) and Day 1 (-10 minutes, 10 minutes, 30 minutes, 1, 2, 4, 8, 12, 16, 18, 20, 24, 28, 32, 36 and 48 hours)

Timeline

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

  1. First posted17 Dec 2021
  2. Study start25 Dec 2021
  3. Primary completion30 Dec 2022
  4. Study completion30 Dec 2022

Why it stopped: After recruitment of Cohorts 1-4 was completed, Sponsor decided to terminate study, initially due to COVID and then considering that PK data from the dose planned to be tested in Cohort 5 (18000 mg) would be available from the ongoing Phase 3 study.

Resources

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
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05162131
Sponsor's protocol ID
PB2452-PT-CL-0006
Status last verified
Jan 2024
First submitted
2 Dec 2021
Last updated
22 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study of Healthy, run by SFJ Pharmaceuticals, Inc. at 1 site in China.

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 12 inclusion and 30 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: stopped early, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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?

The study was stopped early (reason given: After recruitment of Cohorts 1-4 was completed, Sponsor decided to terminate study, initially due to COVID and then considering that PK data from the dose planned to be tested in Cohort 5 (18000 mg) would be available from the ongoing Phase 3 study.). Results are not available in the source record.

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?

Incidence and severity of AEs (time frame: Time Frame: 60 days - Starting up to 28 days prior to dosing). The study lists 11 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 NCT05162131.

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 22 Jan 2024.

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