Trial Outcomes & Findings for A Phase Ib/II in Patients With Acute Ischemic Stroke (NCT NCT02963376)

NCT ID: NCT02963376

Last Updated: 2021-09-24

Results Overview

The primary objective of this study is to establish the Maximum Tolerated Dose (MTD) of DDFPe given intravenously at intervals of 90 ± 10 minutes x 3 doses within 12 hours after subjects have had a documented Acute Ischemic Stroke (AIS). The algorithm for determining the MTD is based on the number of subjects who experience a Dose Limiting Toxicity (DLT) in each cohort, as defined in the clinical protocol. If three or more subjects who received DDFPe in an 8 subject cohort experience a DLT, the MTD will be determined to have been exceeded and further enrollment in the cohort as well as dose escalation will stop.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 24 participants
• Primary outcome timeframe: 12 hours after subjects have had a documented Acute Ischemic Stroke (AIS)
• Results posted on: 2021-09-24

Participant Flow

During the study period, 26 patients or their legal authorized representatives were contacted and agreed to participate. Of these, 24 give written informed consent and were included in the study.

Participant milestones

Measure	0.05 mL/kg DDFPe This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. 0.05 mL/kg DDFPe: Prior to injection, DDFPe will be prepared by pharmacy staff. DDFPe will be administered based on weight. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. DDFPe dosage volume in cc for 0.05 mL/kg based on patient body weight in kilograms (kg).	0.05 mL/kg Placebo This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. 0.05 mL/kg Placebo: Prior to injection, the placebo will be prepared by pharmacy staff. The placebo will be administered based on weight at designated doses Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. The placebo dosage volume in cc for 0.05 mL/kg is based on patient body weight in kilograms (kg).	0.10 mL/kg DDFPe This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. 0.10 mL/kg DDFPe: Prior to injection, DDFPe will be prepared by pharmacy staff. DDFPe will be administered based on weight at designated doses. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. DDFPe dosage volume in cc for 0.10 mL/kg based on patient body weight in kilograms (kg).	0.10 mL/kg Placebo This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. 0.10 mL/kg Placebo: Prior to injection, the placebo will be prepared by pharmacy staff. The placebo will be administered based on weight at designated doses. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. The placebo dosage volume in cc for 0.10 mL/kg is based on patient body weight in kilograms (kg).	0.17 mL/kg DDFPe This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. 0.17 mL/kg DDFPe: Prior to injection, DDFPe will be prepared by pharmacy staff. DDFPe will be administered based on weight at designated doses. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. DDFPe dosage volume in cc for 0.17 mL/kg based on patient body weight in kilograms (kg).	0.17 mL/kg Placebo This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. 0.17 mL/kg Placebo: Prior to injection, the placebo will be prepared by pharmacy staff. The placebo will be administered based on weight at designated doses. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. The placebo dosage volume in cc for 0.17 mL/kg is based on patient body weight in kilograms (kg).
Overall Study STARTED	6	2	6	2	6	2
Overall Study COMPLETED	6	2	6	2	6	2
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase Ib/II in Patients With Acute Ischemic Stroke

Baseline characteristics by cohort

Measure	Controls (n=6) n=6 Participants This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. For analysis, all control subjects are grouped.	DDFPe - 0.05 mL/kg (n=6) n=6 Participants This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.	DDFPe - 0.10 mL/kg (n=6) n=6 Participants This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.	DDFPe - 0.17 mL/kg (n=6) n=6 Participants This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.	Total n=24 Participants Total of all reporting groups
Age, Continuous	56.0 years STANDARD_DEVIATION 7.1 • n=93 Participants	61.2 years STANDARD_DEVIATION 4.4 • n=4 Participants	53.2 years STANDARD_DEVIATION 4.8 • n=27 Participants	56.2 years STANDARD_DEVIATION 4.6 • n=483 Participants	56.6 years STANDARD_DEVIATION 2.6 • n=36 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants	2 Participants n=483 Participants	7 Participants n=36 Participants
Sex: Female, Male Male	5 Participants n=93 Participants	4 Participants n=4 Participants	4 Participants n=27 Participants	4 Participants n=483 Participants	17 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	3 Participants n=36 Participants
Race (NIH/OMB) White	5 Participants n=93 Participants	5 Participants n=4 Participants	6 Participants n=27 Participants	5 Participants n=483 Participants	21 Participants n=36 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Region of Enrollment United States	6 Participants n=93 Participants	6 Participants n=4 Participants	6 Participants n=27 Participants	6 Participants n=483 Participants	24 Participants n=36 Participants
NIHSS Assessment	9.5 units on a scale n=93 Participants	6.5 units on a scale n=4 Participants	8 units on a scale n=27 Participants	4 units on a scale n=483 Participants	6.5 units on a scale n=36 Participants

PRIMARY outcome

Timeframe: 12 hours after subjects have had a documented Acute Ischemic Stroke (AIS)

Population: No signs of dose-limiting episodes were identified at any dose level, and no MTD was defined.

The primary objective of this study is to establish the Maximum Tolerated Dose (MTD) of DDFPe given intravenously at intervals of 90 ± 10 minutes x 3 doses within 12 hours after subjects have had a documented Acute Ischemic Stroke (AIS). The algorithm for determining the MTD is based on the number of subjects who experience a Dose Limiting Toxicity (DLT) in each cohort, as defined in the clinical protocol. If three or more subjects who received DDFPe in an 8 subject cohort experience a DLT, the MTD will be determined to have been exceeded and further enrollment in the cohort as well as dose escalation will stop.

Outcome measures

Measure	0.05 mL/kg DDFPe n=6 Participants This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.	0.05 mL/kg Placebo n=2 Participants This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.	0.10 mL/kg DDFPe n=6 Participants This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.	0.10 mL/kg Placebo n=2 Participants This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.	0.17 mL/kg DDFPe n=6 Participants This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.	0.17 mL/kg Placebo n=2 Participants This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.
Maximum Tolerated Dose (MTD) of DDFPe Evaluated by Number of Dose Limiting Toxicities	0 Dose Limiting Toxicities	0 Dose Limiting Toxicities	0 Dose Limiting Toxicities	0 Dose Limiting Toxicities	0 Dose Limiting Toxicities	0 Dose Limiting Toxicities

SECONDARY outcome

Timeframe: NIHSS scores were recorded at outside hospitals when appropriate and also at the study center as inside baseline NIHSS score. Repeat NIHSS scores were recorded at 2, 3.5, and 7.5 hours after drug injection and on discharge.

Population: At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. All control subjects are grouped for the NIHSS results. DDFPe results are shown separately for each cohort as well as combined.

The NIH Stroke Scale (NIHSS) is an assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The NIHSS is a 15-item neurologic examination. Ratings for each item are scored on a 3- to 5-point scale with 0 as normal. Scores range from 0 to 42, with higher scores indicating greater severity.

Outcome measures

Measure	0.05 mL/kg DDFPe n=6 Participants This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.	0.05 mL/kg Placebo n=18 Participants This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.	0.10 mL/kg DDFPe n=6 Participants This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.	0.10 mL/kg Placebo n=6 Participants This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.	0.17 mL/kg DDFPe n=6 Participants This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.	0.17 mL/kg Placebo This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.
NIHSS Assessment Baseline (PreRx)	9.5 units on a scale Interval 3.0 to 17.0	6.5 units on a scale Interval 0.0 to 14.0	6.5 units on a scale Interval 0.0 to 12.0	8 units on a scale Interval 4.0 to 13.0	4 units on a scale Interval 2.0 to 14.0	—
NIHSS Assessment 2 hours	8 units on a scale Interval 3.0 to 17.0	5 units on a scale Interval 0.0 to 15.0	6 units on a scale Interval 0.0 to 14.0	6.5 units on a scale Interval 1.0 to 15.0	2 units on a scale Interval 0.0 to 6.0	—
NIHSS Assessment 3.5 hours	5.5 units on a scale Interval 3.0 to 14.0	4.5 units on a scale Interval 0.0 to 15.0	5.5 units on a scale Interval 0.0 to 12.0	7 units on a scale Interval 1.0 to 15.0	2.5 units on a scale Interval 0.0 to 5.0	—
NIHSS Assessment 7.5 hours	4.5 units on a scale Interval 2.0 to 14.0	2.5 units on a scale Interval 0.0 to 13.0	5.5 units on a scale Interval 0.0 to 9.0	5.5 units on a scale Interval 1.0 to 13.0	2 units on a scale Interval 0.0 to 4.0	—
NIHSS Assessment Day 7 or Day of Discharge	3.5 units on a scale Interval 1.0 to 11.0	1 units on a scale Interval 0.0 to 11.0	2 units on a scale Interval 0.0 to 5.0	4 units on a scale Interval 0.0 to 11.0	1 units on a scale Interval 0.0 to 2.0	—

SECONDARY outcome

Timeframe: mRS values were obtained on Day 7 or Day of Discharge, Day 30 and Day 90.

Population: At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. All control subjects are grouped for the mRS results. DDFPe results are shown separately for each cohort as well as combined.

The modified Rankin Scale is a measure of the degree of disability in patients who have had a stroke with 0 being no symptoms at all to 6 being death. Thus, a higher score indicates greater severity.

Outcome measures

Measure	0.05 mL/kg DDFPe n=6 Participants This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.	0.05 mL/kg Placebo n=18 Participants This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.	0.10 mL/kg DDFPe n=6 Participants This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.	0.10 mL/kg Placebo n=6 Participants This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.	0.17 mL/kg DDFPe n=6 Participants This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.	0.17 mL/kg Placebo This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.
Modified Rankin Scale (mRS) Day 7 or Day of Discharge	2 units on a scale Interval 1.0 to 4.0	2 units on a scale Interval 0.0 to 4.0	2 units on a scale Interval 0.0 to 3.0	3 units on a scale Interval 0.0 to 4.0	1.5 units on a scale Interval 0.0 to 2.0	—
Modified Rankin Scale (mRS) 30 day	2.5 units on a scale Interval 1.0 to 6.0	1 units on a scale Interval 0.0 to 6.0	2 units on a scale Interval 0.0 to 6.0	2 units on a scale Interval 0.0 to 4.0	0 units on a scale Interval 0.0 to 1.0	—
Modified Rankin Scale (mRS) 90 day	3 units on a scale Interval 0.0 to 6.0	1 units on a scale Interval 0.0 to 6.0	1.5 units on a scale Interval 0.0 to 6.0	2 units on a scale Interval 0.0 to 3.0	0 units on a scale Interval 0.0 to 1.0	—

Adverse Events

Controls (n=6)

Serious events: 3 serious events

Other events: 6 other events

Deaths: 1 deaths

DDFPe - 0.05 mL/kg (n=6)

Serious events: 1 serious events

Other events: 6 other events

Deaths: 1 deaths

DDFPe - 0.10 mL/kg (n=6)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

DDFPe - 0.17 mL/kg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

DDFPe Total (n=18)

Serious events: 1 serious events

Other events: 15 other events

Deaths: 1 deaths

Serious adverse events

Measure	Controls (n=6) n=6 participants at risk This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. For this reason, all control subjects are grouped.	DDFPe - 0.05 mL/kg (n=6) n=6 participants at risk This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.	DDFPe - 0.10 mL/kg (n=6) n=6 participants at risk This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.	DDFPe - 0.17 mL/kg n=6 participants at risk This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.	DDFPe Total (n=18) n=18 participants at risk This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.
Psychiatric disorders Confusional State	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/18 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Psychiatric disorders Depression	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/18 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Surgical and medical procedures Cardiac Pacemaker Replacement	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/18 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Gastrointestinal disorders Abdominal Pain	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/18 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Nervous system disorders Cerebrovascular Accident, Secondary Stroke	33.3% 2/6 • Number of events 2 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/18 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Infections and infestations Pneumonia	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	5.6% 1/18 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Nervous system disorders Migraine	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/18 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.

Other adverse events

Measure	Controls (n=6) n=6 participants at risk This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo. For this reason, all control subjects are grouped.	DDFPe - 0.05 mL/kg (n=6) n=6 participants at risk This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.	DDFPe - 0.10 mL/kg (n=6) n=6 participants at risk This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.	DDFPe - 0.17 mL/kg n=6 participants at risk This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.	DDFPe Total (n=18) n=18 participants at risk This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.
Blood and lymphatic system disorders Anemia	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	5.6% 1/18 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	5.6% 1/18 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Cardiac disorders Arrythmia	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	16.7% 1/6 • Number of events 4 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	5.6% 1/18 • Number of events 4 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Cardiac disorders Cardiac Failure Congestive	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	5.6% 1/18 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Cardiac disorders Electrocardiogram Abnormal	16.7% 1/6 • Number of events 2 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/18 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Cardiac disorders Sinus Bradycardia	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	5.6% 1/18 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Cardiac disorders Myocardial Infarction	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	5.6% 1/18 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Gastrointestinal disorders Nausea	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	33.3% 2/6 • Number of events 2 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	11.1% 2/18 • Number of events 2 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
General disorders Infusion Related Reaction	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	33.3% 2/6 • Number of events 4 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	11.1% 2/18 • Number of events 4 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
General disorders Oedema Peripheral	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	5.6% 1/18 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
General disorders Pyrexia	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	5.6% 1/18 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
General disorders Vascular device occlusion	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	16.7% 1/6 • Number of events 2 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	5.6% 1/18 • Number of events 2 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Injury, poisoning and procedural complications Fall	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	33.3% 2/6 • Number of events 2 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	11.1% 2/18 • Number of events 2 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Injury, poisoning and procedural complications Thermal Burn	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	5.6% 1/18 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	5.6% 1/18 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Musculoskeletal and connective tissue disorders Back Pain	16.7% 1/6 • Number of events 2 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	33.3% 2/6 • Number of events 2 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	11.1% 2/18 • Number of events 2 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	5.6% 1/18 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Nervous system disorders Akathisia	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	5.6% 1/18 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Nervous system disorders Cerebrovascular Accident	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	5.6% 1/18 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Nervous system disorders Dizziness	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/18 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Nervous system disorders Headache	33.3% 2/6 • Number of events 2 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	16.7% 1/6 • Number of events 2 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	33.3% 2/6 • Number of events 3 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	16.7% 3/18 • Number of events 5 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Nervous system disorders Hypoaesthesia	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	5.6% 1/18 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Nervous system disorders Neuralgia	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	5.6% 1/18 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Psychiatric disorders Agitation	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/18 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Renal and urinary disorders Acute Kidney Injury	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	5.6% 1/18 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	33.3% 2/6 • Number of events 2 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	22.2% 4/18 • Number of events 4 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	5.6% 1/18 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Respiratory, thoracic and mediastinal disorders Respiration abnormal	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	5.6% 1/18 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Respiratory, thoracic and mediastinal disorders Sleep Apnoea Syndrome	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	5.6% 1/18 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Respiratory, thoracic and mediastinal disorders Tachypnea	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	5.6% 1/18 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	5.6% 1/18 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Surgical and medical procedures Carotid Endarterectomy	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	5.6% 1/18 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Vascular disorders Flushing	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	33.3% 2/6 • Number of events 5 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	11.1% 2/18 • Number of events 5 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Vascular disorders Haemorrhoids	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	5.6% 1/18 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Vascular disorders Hypertension	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	33.3% 2/6 • Number of events 6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	33.3% 2/6 • Number of events 2 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	22.2% 4/18 • Number of events 8 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.
Vascular disorders Hypotension	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	16.7% 1/6 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	0.00% 0/6 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.	5.6% 1/18 • Number of events 1 • The study treatment follow-up was within 90 days following the last administration of study treatment. At each of the three dose levels (0.05, 0.10, 0.17 mL/kg) six subjects received DDFPe and two received placebo in this study. For this reason, all control subjects are grouped.

Additional Information

Evan Unger, MD

NuvOx Pharma

Phone: 520-624-6688

Email: eunger@nuvoxpharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place