Heart FailurePhase 2NCT02808585
Study to Assess the Safety, Tolerability and PK/PD After 4 Weekly SC Injections of PB1046 in Subjects With Stable HFrEF
A Phase 2 study testing PB1046 Injection in people with Heart Failure, run by PhaseBio Pharmaceuticals Inc. at 5 sites in United States.
Trial summary
This study will be a sequential multiple-dose escalation study that will enroll (randomize and dose) approximately 28 subjects in four cohorts consisting of 3 active and 1 placebo in Cohort 1 and 6 active and 2 placebo in subsequent cohorts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- PB1046 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2016to 6 Dec 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to sign a written informed consent and follow all study-related procedures,
- Male subjects and female subjects of reproductive or childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study drug,
- Body mass index ≥ 18 kg/m2 and ≤ 45 kg/m2,
- Receipt of stable pharmacological therapy(ies) for heart failure for a minimum of 1 month prior to screening and between screening and randomization and are in stable clinical condition,
- NYHA Class II or III heart failure diagnosis (ischemic or non-ischemic confirmed by medical history) at least 6 months prior to screening,
- Stable HF defined as no hospitalizations for cardiac related issues within the previous 3 months prior to the screening visit or between screening and randomization,
Show all 10Show fewer
- A screening or historical Left Ventricular Ejection Fraction ≤ 40% by centralized reading of 2-D echocardiography,
- Screening hemoglobin ≥ 9.0 g/dL secondary to the volume of blood to be collected during the study period,
- Willing and able to return to the study unit for specified study visits, and be able to self-monitor blood pressure while at home,
- Live and work in an area with reliable cellular services (e.g., Sprint®) for real time transmission of telemetry data to the core laboratory.
Who cannot join
- Have previously received PB1046 or have a known allergy to the study drug or any of its components,
- Participating in any other study and have received any other investigational medication or device within 30 days prior to screening or are taking part in a non-medication study which, in the opinion of the Investigator, would interfere with study compliance or outcome assessments,
- Diagnosed with acute coronary syndrome (ACS) or an acute myocardial infarction (MI) within 3 months of screening,
- Canadian Cardiovascular Society (CCS) Class III or IV angina necessitating frequent use of as needed short acting nitroglycerin,
- Cardiac surgery or valvuloplasty within 3 months prior to screening,
- Cerebrovascular accident or transient ischemic attack within 3 months prior to screening,
Show all 16Show fewer
- Sustained systolic blood pressure (SBP) < 110 mmHg and/or diastolic blood pressure (DBP) < 50 mmHg (confirmed by a duplicate seated reading) on at least 3 consecutive readings (self-monitored or office) prior to randomization or overt symptomatic hypotension,
- Sustained resting heart rate >100 beats per minute (BPM) at screening (V1) or prior to randomization,
- History or evidence of clinically significant arrhythmias (uncontrolled by drug therapy or use of an implantable defibrillator), long QT syndrome or evidence of QT prolongation demonstrating QTcF > 460 ms prior to randomization (Subjects with QTcF >460 ms due to electronic pacing by an implanted pacemaker/ICD device may be enrolled),
- Clinically significant renal dysfunction as measured by the estimated glomerular filtration rate (eGFR) of < 40 mL/min/1.73m2 as calculated by the CKD-EPI creatinine-cystatin C equation at screening, or a clinically significant change in renal function between screening and baseline,
- Clinically significant liver dysfunction as measured by: alanine aminotransferase >3.0 × the upper limit of normal (ULN), aspartate aminotransferase >3.0 × the ULN, or serum bilirubin ≥ 1.6 mg/dL at screening, or a clinically significant change in liver function between screening and baseline,
- Pregnant or lactating female subjects,
- Known history of or active alcohol abuse or use of illicit drugs within 1 year prior to randomization,
- Positive screening for human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C virus antibodies,
- Any major surgical procedure within 1 month prior to screening or planned surgical procedure during the study period,
- Other medical or psychiatric condition which, in the opinion of the Investigator, would place the subject at increased risk or would preclude obtaining voluntary consent/assent or would confound the secondary objectives of study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Pinnacle Research Group, LLC
Anniston, Alabama, 36207
Cardiology Associates Research Company
Daytona Beach, Florida, 32117
North Dallas Research Associates
McKinney, Texas, 75069
Revivial Research
Miami, Florida, 33173
Phoenix Medical Research
Peoria, Arizona, 85381
About this study
Official title: Randomized, Double-blind, Placebo-controlled, Multiple-Dose, Study to Assess the Safety, Tolerability, PK and PD After 4 Weeks of Once Weekly Sc. Inj. of PB1046 in Adults With Stable HFrEF, and in Subjects With Cardiac Dysfunction Secondary to DMD
This study will be a sequential multiple-dose escalation study that will enroll (randomize and dose) approximately 28 subjects in four cohorts consisting of 3 active and 1 placebo in Cohort 1 and 6 active and 2 placebo in subsequent cohorts. Randomized subjects will receive a fixed weekly dose of study drug or placebo for a 4 week dosing period.
Read the detailed description
Qualifying subjects will have a diagnosis of NYHA Class II or III heart failure with a reduced ejection fraction (HFrEF), be in stable condition, and be taking clinician-directed appropriate pharmacological therapy (e.g., angiotensin converting enzyme inhibitors, angiotensin receptor blockers or an evidence based beta blocker) for heart failure at stable doses (with the exception of diuretics) for at least 1 month prior to screening.
During the period between screening and randomization (planned first dose), the study subject will remain on stable pharmacological therapy for heart failure. Also the study subject will be in stable health with no hospitalizations or clinically significant acute illnesses between screening and randomization that would put the subject at increased risk for study participation.
Randomized subjects will receive a fixed weekly dose of study drug or placebo for a 4 week dosing period. Dose escalation in subsequent cohorts will continue if the safety and pharmacokinetic profile are deemed acceptable as assessed by the Study Review Committee.
- Conditions
- Heart Failure
- Being tested
- PB1046 Injection, Placebo Injection
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PB1046 InjectionDrug
Also called PB1046
Four weekly subcutaneous injections of PB1046.
Placebo InjectionDrug
Also called Placebo
Four weekly subcutaneous injections of placebo.
| Study group | Role | What they receive |
|---|---|---|
| PB1046 Injection, 0.2 mg/kg | Experimental | Four weekly doses of PB1046 Injection, 0.2 mg/kg Receives: Drug: PB1046 Injection |
| PB1046 Injection, 0.4 mg/kg | Experimental | Four weekly doses of PB1046 Injection, 0.4 mg/kg Receives: Drug: PB1046 Injection |
| PB1046 Injection, 0.6 mg/kg | Experimental | Four weekly doses of PB1046 Injection, 0.6 mg/kg Receives: Drug: PB1046 Injection |
| PB1046 Injection, 1.2 mg/kg | Experimental | Four weekly doses of PB1046 Injection, 1.2 mg/kg Receives: Drug: PB1046 Injection |
| Placebo Comparator | Placebo comparator | Four weekly doses of Placebo (0.9% NaCl) Injection Receives: Drug: Placebo Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Telemetry
Number of participants with rhythm abnormalities as assessed by continuous mobile telemetry monitoring.
Measured: Up to six weeks starting 7 to 10 days before first dose.
12-Lead ECG Assessment - Incidence of Clinically Significant Findings
Number of participants with a clinically significant change from baseline in 12-Lead ECG and presence of rhythm abnormalities and relationship to exposure of PB1046 compared to placebo
Measured: Seven weeks starting the first week of dosing.
12-Lead ECG - Categorical Analysis of QT/QTc Interval - Participants With Clinically Significant Findings
Number of participants with a clinically significant change from baseline in 12-Lead ECG and presence or absence of rhythm abnormalities and relationship to exposure of PB1046 compared to placebo
Measured: Seven weeks starting the first week of dosing.
Laboratory Parameters - Serum Chemistry - Participants With Clinically Significant Findings
Number of participants with clinically significant changes from baseline in laboratory parameters (serum chemistry) and the relationship to PB1046 compared to placebo
Measured: Eight weeks starting one week before first dose.
Laboratory Parameters - Hematology - Participants With Clinically Significant Findings
Number of participants with clinically significant changes from baseline in laboratory parameters (hematology) and the relationship to PB1046 compared to placebo
Measured: Eight weeks starting one week before first dose.
Laboratory Parameters - Urinalysis - Participants With Clinically Significant Findings
Number of participants with clinically significant changes from baseline in laboratory parameters (urinalysis) and the relationship to PB1046 compared to placebo
Measured: Eight weeks starting one week before first dose.
Laboratory Parameters - eGFR
Changes from baseline in laboratory parameters (eGFR) and the relationship to PB1046 compared to placebo.
Calculated using Chronic Kidney Disease Epidemiology Collaboration Equation (CKD-EPI)
Measured: Baseline, Week 2, 3, 4, 5 and 8.
Laboratory Parameters - Lipid Profile - Participants With Clinically Significant Findings
Number of participants with clinically significant changes from baseline in laboratory parameters (lipid profile) and the relationship to PB1046 compared to placebo
Measured: Eight weeks starting one week before first dose (Baseline and at Week 8).
Vital Signs - Systolic Blood Pressure
Changes from baseline in vital signs (systolic blood pressure) and the relationship to PB1046 compared to placebo.
Measured: Baseline, Day 0, Day 1, 2, 3, 5, 7, 14, 21, 22, 23, 24, 26, 28, 29, 30, 31, and 49.
Vital Signs - Heart Rate
Changes from baseline in vital signs (heart rate) and the relationship to PB1046 compared to placebo.
Measured: Baseline, Day 0, Day 1, 2, 3, 5, 7, 14, 21, 22, 23, 24, 26, 28, 29, 30, 31, and 49.
Vital Signs - Temperature
Changes from baseline in vital signs (temperature) and the relationship to PB1046 compared to placebo.
Measured: Baseline, Day 0, Day 1, 2, 3, 5, 7, 14, 21, 22, 23, 24, 26, 28, 29, 30, 31, and 49.
Vital Signs - Respiratory Rate
Changes from baseline in vital signs (respiratory rate) and the relationship to PB1046 compared to placebo.
Measured: Baseline, Day 0, Day 1, 2, 3, 5, 7, 14, 21, 22, 23, 24, 26, 28, 29, 30, 31, and 49.
Vital Signs - Diastolic Blood Pressure
Changes from baseline in vital signs (systolic blood pressure) and the relationship to PB1046 compared to placebo.
Measured: Baseline, Day 0, Day 1, 2, 3, 5, 7, 14, 21, 22, 23, 24, 26, 28, 29, 30, 31, and 49.
Secondary outcomes (8)
Pharmacokinetic Profile - Area Under the Curve Over the Dosing Interval [AUC(0-t)]
Comparison of dose exposures [AUC(0-t)] during once weekly administration of various doses of PB1046
Measured: Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31.
Pharmacokinetic Profile - Maximum Serum Concentration (Cmax)
Comparison of dose exposures (Cmax) during once weekly administration of various doses of PB1046
Measured: Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31.
Pharmacokinetic Profile - Time to Cmax (Tmax)
Comparison of dose exposures (Tmax) during once weekly administration of various doses of PB1046
Measured: Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31.
Pharmacokinetic Profile - Elimination Rate Constant (Lambda z)
Comparison of dose exposures (lambda z) during once weekly administration of various doses of PB1046
Measured: Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31.
Pharmacokinetic Profile - Elimination Half-life (t½)
Comparison of dose exposures (t½) during once weekly administration of various doses of PB1046
Measured: Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31.
Pharmacokinetic Profile - Clearance (CL/F), Uncorrected for Bioavailability
Comparison of dose exposures (CL/F) during once weekly administration of various doses of PB1046
Measured: Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31.
Pharmacokinetic Profile - Volume of Distribution (Vz/F), Uncorrected for Bioavailability (F)
Comparison of dose exposures (Vz/F) during once weekly administration of various doses of PB1046
Measured: Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31.
Immunogenicity
Number of participants reporting positive immunogenicity (four-fold increase of pre-dose titer)
Measured: Eleven weeks starting the first week of dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startJun 2016
- Primary completion6 Dec 2017
- Study completion6 Dec 2017
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 Heart FailureStudies 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- PhaseBio Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808585
- Sponsor's protocol ID
- PB1046-PT-CL-0003-P1
- Status last verified
- Jun 2022
- First submitted
- 8 Jun 2016
- Last updated
- 14 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled, Multiple-Dose, Study to Assess the Safety, Tolerability, PK and PD After 4 Weeks of Once Weekly Sc. Inj. of PB1046 in Adults With Stable HFrEF, and in Subjects With Cardiac Dysfunction Secondary to DMD
- ClinicalTrials.gov ID
- NCT02808585
- Acronym / sponsor ID
- PB1046-PT-CL-0003-P1
- Conditions
- Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- PhaseBio Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2016 (actual)
- Primary completion
- 6 Dec 2017 (actual)
- Study completion
- 6 Dec 2017 (actual)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Posted 14 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be a sequential multiple-dose escalation study that will enroll (randomize and dose) approximately 28 subjects in four cohorts consisting of 3 active and 1 placebo in Cohort 1 and 6 active and 2 placebo in subsequent cohorts. Randomized subjects will receive a fixed weekly dose of study drug or placebo for a 4 week dosing period.
Detailed description
Qualifying subjects will have a diagnosis of NYHA Class II or III heart failure with a reduced ejection fraction (HFrEF), be in stable condition, and be taking clinician-directed appropriate pharmacological therapy (e.g., angiotensin converting enzyme inhibitors, angiotensin receptor blockers or an evidence based beta blocker) for heart failure at stable doses (with the exception of diuretics) for at least 1 month prior to screening.
During the period between screening and randomization (planned first dose), the study subject will remain on stable pharmacological therapy for heart failure. Also the study subject will be in stable health with no hospitalizations or clinically significant acute illnesses between screening and randomization that would put the subject at increased risk for study participation.
Randomized subjects will receive a fixed weekly dose of study drug or placebo for a 4 week dosing period. Dose escalation in subsequent cohorts will continue if the safety and pharmacokinetic profile are deemed acceptable as assessed by the Study Review Committee.
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 |
|---|---|---|
| PB1046 Injection, 0.2 mg/kg | Experimental | Drug: PB1046 InjectionFour weekly doses of PB1046 Injection, 0.2 mg/kg |
| PB1046 Injection, 0.4 mg/kg | Experimental | Drug: PB1046 InjectionFour weekly doses of PB1046 Injection, 0.4 mg/kg |
| PB1046 Injection, 0.6 mg/kg | Experimental | Drug: PB1046 InjectionFour weekly doses of PB1046 Injection, 0.6 mg/kg |
| PB1046 Injection, 1.2 mg/kg | Experimental | Drug: PB1046 InjectionFour weekly doses of PB1046 Injection, 1.2 mg/kg |
| Placebo Comparator | Placebo comparator | Drug: Placebo InjectionFour weekly doses of Placebo (0.9% NaCl) Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Willing and able to sign a written informed consent and follow all study-related procedures,
- Male subjects and female subjects of reproductive or childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study drug,
- Body mass index ≥ 18 kg/m2 and ≤ 45 kg/m2,
- Receipt of stable pharmacological therapy(ies) for heart failure for a minimum of 1 month prior to screening and between screening and randomization and are in stable clinical condition,
- NYHA Class II or III heart failure diagnosis (ischemic or non-ischemic confirmed by medical history) at least 6 months prior to screening,
Key exclusion criteria (16 listed)
- Have previously received PB1046 or have a known allergy to the study drug or any of its components,
- Participating in any other study and have received any other investigational medication or device within 30 days prior to screening or are taking part in a non-medication study which, in the opinion of the Investigator, would interfere with study compliance or outcome assessments,
- Diagnosed with acute coronary syndrome (ACS) or an acute myocardial infarction (MI) within 3 months of screening,
- Canadian Cardiovascular Society (CCS) Class III or IV angina necessitating frequent use of as needed short acting nitroglycerin,
- Cardiac surgery or valvuloplasty within 3 months prior to screening,
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 |
|---|---|---|
| PB1046 InjectionAlso: PB1046Four weekly subcutaneous injections of PB1046. | Drug | PB1046 Injection, 0.2 mg/kg, PB1046 Injection, 0.4 mg/kg, PB1046 Injection, 0.6 mg/kg, PB1046 Injection, 1.2 mg/kg |
| Placebo InjectionAlso: PlaceboFour weekly subcutaneous injections of placebo. | Drug | Placebo Comparator |
Primary outcome
Telemetry
Time frame: Up to six weeks starting 7 to 10 days before first dose.
Number of participants with rhythm abnormalities as assessed by continuous mobile telemetry monitoring.
12-Lead ECG Assessment - Incidence of Clinically Significant Findings
Time frame: Seven weeks starting the first week of dosing.
Number of participants with a clinically significant change from baseline in 12-Lead ECG and presence of rhythm abnormalities and relationship to exposure of PB1046 compared to placebo
12-Lead ECG - Categorical Analysis of QT/QTc Interval - Participants With Clinically Significant Findings
Time frame: Seven weeks starting the first week of dosing.
Number of participants with a clinically significant change from baseline in 12-Lead ECG and presence or absence of rhythm abnormalities and relationship to exposure of PB1046 compared to placebo
Laboratory Parameters - Serum Chemistry - Participants With Clinically Significant Findings
Time frame: Eight weeks starting one week before first dose.
Number of participants with clinically significant changes from baseline in laboratory parameters (serum chemistry) and the relationship to PB1046 compared to placebo
Laboratory Parameters - Hematology - Participants With Clinically Significant Findings
Time frame: Eight weeks starting one week before first dose.
Number of participants with clinically significant changes from baseline in laboratory parameters (hematology) and the relationship to PB1046 compared to placebo
Laboratory Parameters - Urinalysis - Participants With Clinically Significant Findings
Time frame: Eight weeks starting one week before first dose.
Number of participants with clinically significant changes from baseline in laboratory parameters (urinalysis) and the relationship to PB1046 compared to placebo
Laboratory Parameters - eGFR
Time frame: Baseline, Week 2, 3, 4, 5 and 8.
Changes from baseline in laboratory parameters (eGFR) and the relationship to PB1046 compared to placebo. Calculated using Chronic Kidney Disease Epidemiology Collaboration Equation (CKD-EPI)
Laboratory Parameters - Lipid Profile - Participants With Clinically Significant Findings
Time frame: Eight weeks starting one week before first dose (Baseline and at Week 8).
Number of participants with clinically significant changes from baseline in laboratory parameters (lipid profile) and the relationship to PB1046 compared to placebo
Vital Signs - Systolic Blood Pressure
Time frame: Baseline, Day 0, Day 1, 2, 3, 5, 7, 14, 21, 22, 23, 24, 26, 28, 29, 30, 31, and 49.
Changes from baseline in vital signs (systolic blood pressure) and the relationship to PB1046 compared to placebo.
Vital Signs - Heart Rate
Time frame: Baseline, Day 0, Day 1, 2, 3, 5, 7, 14, 21, 22, 23, 24, 26, 28, 29, 30, 31, and 49.
Changes from baseline in vital signs (heart rate) and the relationship to PB1046 compared to placebo.
Vital Signs - Temperature
Time frame: Baseline, Day 0, Day 1, 2, 3, 5, 7, 14, 21, 22, 23, 24, 26, 28, 29, 30, 31, and 49.
Changes from baseline in vital signs (temperature) and the relationship to PB1046 compared to placebo.
Vital Signs - Respiratory Rate
Time frame: Baseline, Day 0, Day 1, 2, 3, 5, 7, 14, 21, 22, 23, 24, 26, 28, 29, 30, 31, and 49.
Changes from baseline in vital signs (respiratory rate) and the relationship to PB1046 compared to placebo.
Vital Signs - Diastolic Blood Pressure
Time frame: Baseline, Day 0, Day 1, 2, 3, 5, 7, 14, 21, 22, 23, 24, 26, 28, 29, 30, 31, and 49.
Changes from baseline in vital signs (systolic blood pressure) and the relationship to PB1046 compared to placebo.
8 secondary outcomes
Pharmacokinetic Profile - Area Under the Curve Over the Dosing Interval [AUC(0-t)]
Time frame: Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31.
Pharmacokinetic Profile - Maximum Serum Concentration (Cmax)
Time frame: Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31.
Pharmacokinetic Profile - Time to Cmax (Tmax)
Time frame: Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31.
Pharmacokinetic Profile - Elimination Rate Constant (Lambda z)
Time frame: Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31.
Pharmacokinetic Profile - Elimination Half-life (t½)
Time frame: Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31.
Pharmacokinetic Profile - Clearance (CL/F), Uncorrected for Bioavailability
Time frame: Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31.
Pharmacokinetic Profile - Volume of Distribution (Vz/F), Uncorrected for Bioavailability (F)
Time frame: Pre-dose, Day 1 post-dose (1, 3, 24, 48, 72, 120 hours post-dose 1), Day 7, 14, 21 (1, 3, 24, 48, 72, 120 hours post-dose 4), Day 22, 23, 24, 26, 28, 29, 30, and 31.
Immunogenicity
Time frame: Eleven weeks starting the first week of dosing.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PB1046 Injection in people with Heart Failure, run by PhaseBio Pharmaceuticals Inc. at 5 sites 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 10 inclusion and 16 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 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 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 14 Jul 2022). 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?
Telemetry (time frame: Up to six weeks starting 7 to 10 days before first dose.). The study lists 13 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 14 Jul 2022; AzTrials last refreshed its copy on 6 Nov 2026.