Trial Outcomes & Findings for Safety of PZ-128 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention (NCT NCT02561000)

Last Updated: 2025-04-16

Results Overview

All suspected bleeding events positively adjudicated by CEC in a blinded fashion, were used in the reporting of the number/percentage of observed participants with a first occurrence of a TIMI major or minor bleeding event.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

100 participants

Primary outcome timeframe

From initiation of study drug up to 30 days following study drug

Results posted on

2025-04-16

Participant Flow

NCT02561000: Study TMC-PZ128-02 (TRIP-PCI Trial) was conducted at 3 centers in the U.S. between 27 May 2016 and 25 May 2018. A total of 3056 patients were screened for study and 100 patients were randomly assigned to treatment.

Of the 3056 patients pre-screened for study, 2956 patients were pre-screening failures, and 100 patients were randomly assigned to treatment. Of the 100 patients, 3 never received study drug (2 withdrew following randomization and 1 experienced an adverse event pre-dose), leaving 97 patients valid for the primary safety analysis. All randomized patients with at least 1 follow-up assessment (98 patients) were included in the intent-to-treat (ITT) analysis set for secondary efficacy analyses.

Participant milestones

Participant milestones
Measure	Placebo Placebo, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion Placebo	PZ-128 0.3 mg/kg PZ-128, 0.3 mg/kg, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion PZ-128	PZ-128 0.5 mg/kg PZ-128, 0.5 mg/kg, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion PZ-128
Overall Study STARTED	34	35	31
Overall Study Safety Population	35	31	31
Overall Study Intent-to-Treat (ITT) Population at 30 Days	34	33	31
Overall Study Intent-to-Treat (ITT) Population at 90 Days	33	31	31
Overall Study COMPLETED	32	31	31
Overall Study NOT COMPLETED	2	4	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion Placebo	PZ-128 0.3 mg/kg PZ-128, 0.3 mg/kg, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion PZ-128	PZ-128 0.5 mg/kg PZ-128, 0.5 mg/kg, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion PZ-128
Overall Study Withdrawal by Subject	2	3	0
Overall Study Adverse Event	0	1	0

Baseline Characteristics

Safety of PZ-128 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=34 Participants Placebo, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion Placebo	PZ-128 0.3 mg/kg n=35 Participants PZ-128, 0.3 mg/kg, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion PZ-128	PZ-128 0.5 mg/kg n=31 Participants PZ-128, 0.5 mg/kg, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion PZ-128	Total n=100 Participants Total of all reporting groups
Age, Continuous	59.2 years STANDARD_DEVIATION 12.1 • n=5 Participants	62.4 years STANDARD_DEVIATION 11.0 • n=7 Participants	63.2 years STANDARD_DEVIATION 8.6 • n=5 Participants	61.5 years STANDARD_DEVIATION 10.8 • n=4 Participants
Age, Customized <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Customized Between 18 and 65 years	20 Participants n=5 Participants	13 Participants n=7 Participants	14 Participants n=5 Participants	47 Participants n=4 Participants
Age, Customized >=65 years	10 Participants n=5 Participants	17 Participants n=7 Participants	14 Participants n=5 Participants	41 Participants n=4 Participants
Age, Customized >=75 years	4 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	12 Participants n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants	16 Participants n=4 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	33 Participants n=7 Participants	24 Participants n=5 Participants	84 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants	35 Participants n=7 Participants	30 Participants n=5 Participants	97 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants	29 Participants n=7 Participants	30 Participants n=5 Participants	89 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	34 participants n=5 Participants	35 participants n=7 Participants	31 participants n=5 Participants	100 participants n=4 Participants

PRIMARY outcome

Timeframe: From initiation of study drug up to 30 days following study drug

Population: The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated). Four patients assigned to PZ-128 0.3 mg/kg did not receive randomized treatment allocation: 1 patient received placebo in error and was evaluated as placebo for primary safety outcome and adverse events; 2 patients withdrew consent right after randomization; and 1 patient had an adverse event prior to receiving any study drug.

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants Placebo, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion Placebo	PZ-128 0.3 mg/kg n=31 Participants PZ-128, 0.3 mg/kg, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion PZ-128	PZ-128 0.5 mg/kg n=31 Participants PZ-128, 0.5 mg/kg, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion PZ-128
First Occurrence of Major Plus Minor Thrombolysis in Myocardial Infarction (TIMI) Bleeding Events; Number/Percentage of Observed Participants With Outcome Measure Events During the Study (Primary Safety)	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From randomization up to 30 days following study drug

Population: The Intent-to-treat (ITT) population included all randomized participants, regardless of study drug intake, who underwent at least 1 follow-up assessment within 30 days after study drug dosing. Two patients (PZ-128 0.3 mg/kg) could not be evaluated for the 30-day outcome due to complete study withdrawal shortly after randomization.

All suspected MACE events positively adjudicated by Clinical Events Committee (CEC) in a blinded fashion, were used in the reporting of the number/percentage of observed participants with a first occurrence of the composite cardiovascular (CV) outcome measure comprised of CV death, non-fatal Myocardial Infarction (MI), non-fatal stroke (ischemic, hemorrhagic or unknown), recurrent ischemia requiring hospitalization, or urgent coronary revascularization. The number/percentage of observed participants with outcome measure events during the study were reported.

Outcome measures

Outcome measures
Measure	Placebo n=34 Participants Placebo, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion Placebo	PZ-128 0.3 mg/kg n=33 Participants PZ-128, 0.3 mg/kg, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion PZ-128	PZ-128 0.5 mg/kg n=31 Participants PZ-128, 0.5 mg/kg, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion PZ-128
First Occurrence of Major Adverse Cardiovascular Event (MACE); Number/Percentage of Observed Participants With Outcome Measure Events During the Study (Secondary Efficacy)	2 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From randomization up to 90 days following study drug

Population: The Intent-to-treat (ITT) population included all randomized participants, regardless of study drug intake, who underwent at least 1 follow-up assessment after 30 days up until 90 days after study drug dosing. 5 patients could not be evaluated for the 90-day outcome: 1 placebo withdrew at 21 d; 2 PZ-128 0.3 mg/kg withdrew post randomization; 1 PZ-128 0.3 mg/kg withdrew at 7 d; and 1 PZ-128 0.3 mg/kg patient was followed only for 30 d ITT outcome (no study drug due to AE post randomization).

Outcome measures

Outcome measures
Measure	Placebo n=33 Participants Placebo, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion Placebo	PZ-128 0.3 mg/kg n=31 Participants PZ-128, 0.3 mg/kg, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion PZ-128	PZ-128 0.5 mg/kg n=31 Participants PZ-128, 0.5 mg/kg, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion PZ-128
First Occurrence of Major Adverse Cardiovascular Event (MACE); Number/Percentage of Observed Participants With Outcome Measure Events During the Study (Secondary Efficacy)	2 Participants	0 Participants	1 Participants

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

PZ-128 0.3 mg/kg

Serious events: 5 serious events

Other events: 8 other events

Deaths: 0 deaths

PZ-128 0.5 mg/kg

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=35 participants at risk Placebo, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion Placebo	PZ-128 0.3 mg/kg n=31 participants at risk PZ-128, 0.3 mg/kg, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion PZ-128	PZ-128 0.5 mg/kg n=31 participants at risk PZ-128, 0.5 mg/kg, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion PZ-128
Musculoskeletal and connective tissue disorders Muscular Weakness	2.9% 1/35 • Number of events 1 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.	0.00% 0/31 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.	0.00% 0/31 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.
Infections and infestations Pneumonia	0.00% 0/35 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.	6.5% 2/31 • Number of events 2 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.	0.00% 0/31 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.
Cardiac disorders Atrial Fibrillation	0.00% 0/35 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.	0.00% 0/31 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.	3.2% 1/31 • Number of events 1 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.
Renal and urinary disorders Nephrolithiasis	0.00% 0/35 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.	3.2% 1/31 • Number of events 1 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.	0.00% 0/31 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.
Cardiac disorders Cardiac Failure Congestive	0.00% 0/35 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.	3.2% 1/31 • Number of events 1 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.	0.00% 0/31 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.
Vascular disorders Hypotension	0.00% 0/35 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.	3.2% 1/31 • Number of events 1 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.	3.2% 1/31 • Number of events 1 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.
Cardiac disorders Aortic Valve Disease	0.00% 0/35 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.	0.00% 0/31 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.	3.2% 1/31 • Number of events 1 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.
Metabolism and nutrition disorders Fluid Overload	0.00% 0/35 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.	3.2% 1/31 • Number of events 1 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.	0.00% 0/31 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.

Other adverse events

Other adverse events
Measure	Placebo n=35 participants at risk Placebo, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion Placebo	PZ-128 0.3 mg/kg n=31 participants at risk PZ-128, 0.3 mg/kg, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion PZ-128	PZ-128 0.5 mg/kg n=31 participants at risk PZ-128, 0.5 mg/kg, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion PZ-128
Cardiac disorders Atrial Fibrillation	5.7% 2/35 • Number of events 2 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.	3.2% 1/31 • Number of events 1 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.	3.2% 1/31 • Number of events 1 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.
Nervous system disorders Headache	5.7% 2/35 • Number of events 2 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.	3.2% 1/31 • Number of events 1 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.	3.2% 1/31 • Number of events 1 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.
Nervous system disorders Hypoesthesia	5.7% 2/35 • Number of events 2 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.	0.00% 0/31 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.	3.2% 1/31 • Number of events 1 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.
Nervous system disorders Paresthesia Oral	0.00% 0/35 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.	16.1% 5/31 • Number of events 5 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.	19.4% 6/31 • Number of events 6 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.
Skin and subcutaneous tissue disorders Rash Pruritic	5.7% 2/35 • Number of events 2 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.	6.5% 2/31 • Number of events 2 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.	16.1% 5/31 • Number of events 5 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.
Vascular disorders Hypotension	0.00% 0/35 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.	0.00% 0/31 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.	16.1% 5/31 • Number of events 5 • All Adverse Events (AEs), including Serious Adverse Events (SAEs), were collected from signature of the informed consent form until 30 days post study drug regardless of relationship to Investigational Product (IP). Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the study drug dosing up to 30 days post dose). Adverse Events do not include Study Endpoint Events. The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated)- See Safety Population Milestone in Participant Flow Overview.

Additional Information

Athan Kuliopulos, MD, PhD

Tufts Medical Center

Phone: 617-636-8482

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60