Trial Outcomes & Findings for Phase 2 Study of Rivaroxaban Reversal by Ciraparantag as Measured by WBCT (NCT NCT03172910)

Last Updated: 2025-09-02

Results Overview

Complete reversal is achieved if WBCT (manual method) is ≤ 110% of baseline at any post-baseline time point up to and including 1 hour following ciraparantag/placebo administration)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

69 participants

Primary outcome timeframe

Within 1 Hour

Results posted on

2025-09-02

Participant Flow

One study site in the US enrolled subjects between May 2017 and November 2019

69 subjects enrolled; 64 subjects were randomized and 5 subjects were not randomized. Of the 5 subjects not randomized, 2 did not achieve a sufficient level of anticoagulation per protocol, 1 was withdrawn by Investigator decision (due to an asymptomatic low heart rate), 1 subject withdrew consent, and 1 had an AE during the rivaroxaban administration period causing discontinuation (T wave inversion observed on ECG).

Participant milestones

Participant milestones
Measure	Placebo Subjects received 20 mg rivaroxaban once daily in the morning on Days 1-3. On Day 3, approximately 4 hours after last rivaroxaban dose, a single IV dose of saline for injection (placebo) was administered.	Ciraparantag 30mg Subjects received 20 mg rivaroxaban once daily in the morning on Days 1-3. On Day 3, approximately 4 hours after last rivaroxaban dose, a single IV dose of 30 mg ciraparantag was administered.	Ciraparantag 60 mg Subjects received 20 mg rivaroxaban once daily in the morning on Days 1-3. On Day 3, approximately 4 hours after last rivaroxaban dose, a single IV dose of 60 mg ciraparantag was administered.	Ciraparantag 120 mg Subjects received 20 mg rivaroxaban once daily in the morning on Days 1-3. On Day 3, approximately 4 hours after last rivaroxaban dose, a single IV dose of 120 mg ciraparantag was administered.	Ciraparantag 180 mg Subjects received 20 mg rivaroxaban once daily in the morning on Days 1-3. On Day 3, approximately 4 hours after last rivaroxaban dose, a single IV dose of 180 mg ciraparantag was administered.
Overall Study STARTED	16	12	12	12	12
Overall Study COMPLETED	16	12	12	12	11
Overall Study NOT COMPLETED	0	0	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Subjects received 20 mg rivaroxaban once daily in the morning on Days 1-3. On Day 3, approximately 4 hours after last rivaroxaban dose, a single IV dose of saline for injection (placebo) was administered.	Ciraparantag 30mg Subjects received 20 mg rivaroxaban once daily in the morning on Days 1-3. On Day 3, approximately 4 hours after last rivaroxaban dose, a single IV dose of 30 mg ciraparantag was administered.	Ciraparantag 60 mg Subjects received 20 mg rivaroxaban once daily in the morning on Days 1-3. On Day 3, approximately 4 hours after last rivaroxaban dose, a single IV dose of 60 mg ciraparantag was administered.	Ciraparantag 120 mg Subjects received 20 mg rivaroxaban once daily in the morning on Days 1-3. On Day 3, approximately 4 hours after last rivaroxaban dose, a single IV dose of 120 mg ciraparantag was administered.	Ciraparantag 180 mg Subjects received 20 mg rivaroxaban once daily in the morning on Days 1-3. On Day 3, approximately 4 hours after last rivaroxaban dose, a single IV dose of 180 mg ciraparantag was administered.
Overall Study Adverse Event	0	0	0	0	1

Baseline Characteristics

Phase 2 Study of Rivaroxaban Reversal by Ciraparantag as Measured by WBCT

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=16 Participants Subjects received 20 mg rivaroxaban once daily in the morning on Days 1-3. On Day 3, approximately 4 hours after last rivaroxaban dose, a single IV dose of saline for injection (placebo) was administered.	Ciraparantag 30 mg n=12 Participants Subjects received 20 mg rivaroxaban once daily in the morning on Days 1-3. On Day 3, approximately 4 hours after last rivaroxaban dose, a single IV dose of 30 mg ciraparantag was administered.	Ciraparantag 60 mg n=12 Participants Subjects received 20 mg rivaroxaban once daily in the morning on Days 1-3. On Day 3, approximately 4 hours after last rivaroxaban dose, a single IV dose of 60 mg ciraparantag was administered.	Ciraparantag 120 mg n=12 Participants Subjects received 20 mg rivaroxaban once daily in the morning on Days 1-3. On Day 3, approximately 4 hours after last rivaroxaban dose, a single IV dose of 120 mg ciraparantag was administered.	Ciraparantag 180 mg n=12 Participants Subjects received 20 mg rivaroxaban once daily in the morning on Days 1-3. On Day 3, approximately 4 hours after last rivaroxaban dose, a single IV dose of 180 mg ciraparantag was administered.	Total n=64 Participants Total of all reporting groups
Age, Continuous	54.3 years STANDARD_DEVIATION 3.89 • n=5 Participants	57.8 years STANDARD_DEVIATION 5.67 • n=7 Participants	56.1 years STANDARD_DEVIATION 6.73 • n=5 Participants	53.8 years STANDARD_DEVIATION 3.10 • n=4 Participants	55.9 years STANDARD_DEVIATION 4.89 • n=21 Participants	55.5 years STANDARD_DEVIATION 5.00 • n=8 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants	9 Participants n=8 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	12 Participants n=4 Participants	9 Participants n=21 Participants	55 Participants n=8 Participants
Race/Ethnicity, Customized White	8 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	5 Participants n=21 Participants	32 Participants n=8 Participants
Race/Ethnicity, Customized Black or African American	8 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	5 Participants n=21 Participants	30 Participants n=8 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants
Region of Enrollment United States	16 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	12 Participants n=4 Participants	12 Participants n=21 Participants	64 Participants n=8 Participants
Baseline Whole Blood Clotting Time (WBCT, manual method)	7.8 minutes STANDARD_DEVIATION 0.36 • n=5 Participants	8.1 minutes STANDARD_DEVIATION 0.42 • n=7 Participants	7.8 minutes STANDARD_DEVIATION 0.25 • n=5 Participants	7.8 minutes STANDARD_DEVIATION 0.33 • n=4 Participants	7.9 minutes STANDARD_DEVIATION 0.36 • n=21 Participants	7.9 minutes STANDARD_DEVIATION .34 • n=8 Participants

PRIMARY outcome

Timeframe: Within 1 Hour

Population: Pharmacodynamic population: all subjects who receive administration of study drug and provide at least one on-treatment whole blood clotting time measurement without protocol deviations with potential to affect these measurements.

Complete reversal is achieved if WBCT (manual method) is ≤ 110% of baseline at any post-baseline time point up to and including 1 hour following ciraparantag/placebo administration)

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants Placebo (saline for injection) Placebo: Saline for injection Rivaroxaban: Rivaroxaban 20 mg given once per day (QD) in the morning	Ciraparantag 30 mg n=12 Participants Subjects received 20 mg rivaroxaban once daily in the morning on Days 1-3. On Day 3, approximately 4 hours after last rivaroxaban dose, a single IV dose of 30 mg ciraparantag was administered.	Ciraparantag 60 mg n=12 Participants Subjects received 20 mg rivaroxaban once daily in the morning on Days 1-3. On Day 3, approximately 4 hours after last rivaroxaban dose, a single IV dose of 60 mg ciraparantag was administered.	Ciraparantag 120 mg n=12 Participants Subjects received 20 mg rivaroxaban once daily in the morning on Days 1-3. On Day 3, approximately 4 hours after last rivaroxaban dose, a single IV dose of 120 mg ciraparantag was administered.	Ciraparantag 180 mg n=12 Participants Subjects received 20 mg rivaroxaban once daily in the morning on Days 1-3. On Day 3, approximately 4 hours after last rivaroxaban dose, a single IV dose of 180 mg ciraparantag was administered.
Subjects Achieving Complete Reversal of Anticoagulation (WBCT is ≤ 110% of Baseline)	3 Participants	7 Participants	11 Participants	11 Participants	12 Participants

PRIMARY outcome

Timeframe: Between 1 and 8 Hours

Complete and sustained reversal of anticoagulation is achieved for a subject if WBCT (manual method) is ≤ 115% of baseline at all time points between 1 and 8 hours (inclusive) following ciraparantag/placebo administration.

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants Placebo (saline for injection) Placebo: Saline for injection Rivaroxaban: Rivaroxaban 20 mg given once per day (QD) in the morning	Ciraparantag 30 mg n=12 Participants Subjects received 20 mg rivaroxaban once daily in the morning on Days 1-3. On Day 3, approximately 4 hours after last rivaroxaban dose, a single IV dose of 30 mg ciraparantag was administered.	Ciraparantag 60 mg n=12 Participants Subjects received 20 mg rivaroxaban once daily in the morning on Days 1-3. On Day 3, approximately 4 hours after last rivaroxaban dose, a single IV dose of 60 mg ciraparantag was administered.	Ciraparantag 120 mg n=12 Participants Subjects received 20 mg rivaroxaban once daily in the morning on Days 1-3. On Day 3, approximately 4 hours after last rivaroxaban dose, a single IV dose of 120 mg ciraparantag was administered.	Ciraparantag 180 mg n=12 Participants Subjects received 20 mg rivaroxaban once daily in the morning on Days 1-3. On Day 3, approximately 4 hours after last rivaroxaban dose, a single IV dose of 180 mg ciraparantag was administered.
Subjects Achieving Complete and Sustained Reversal of Anticoagulation (WBCT is ≤115%of Baseline)	3 Participants	8 Participants	11 Participants	11 Participants	12 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Ciraparantag 30 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ciraparantag 60 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Ciraparantag 120 mg

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Ciraparantag 180 mg

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Enrolled Not Randomized

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=16 participants at risk Subjects received 20 mg rivaroxaban once daily in the morning on Days 1-3. On Day 3, approximately 4 hours after last rivaroxaban dose, a single IV dose of saline for injection (placebo) was administered.	Ciraparantag 30 mg n=12 participants at risk Subjects received 20 mg rivaroxaban once daily in the morning on Days 1-3. On Day 3, approximately 4 hours after last rivaroxaban dose, a single IV dose of 30 mg ciraparantag was administered.	Ciraparantag 60 mg n=12 participants at risk Subjects received 20 mg rivaroxaban once daily in the morning on Days 1-3. On Day 3, approximately 4 hours after last rivaroxaban dose, a single IV dose of 60 mg ciraparantag was administered.	Ciraparantag 120 mg n=12 participants at risk Subjects received 20 mg rivaroxaban once daily in the morning on Days 1-3. On Day 3, approximately 4 hours after last rivaroxaban dose, a single IV dose of 120 mg ciraparantag was administered.	Ciraparantag 180 mg n=12 participants at risk Subjects received 20 mg rivaroxaban once daily in the morning on Days 1-3. On Day 3, approximately 4 hours after last rivaroxaban dose, a single IV dose of 180 mg ciraparantag was administered.	Enrolled Not Randomized n=5 participants at risk Subjects received 20 mg rivaroxaban once daily in the morning on Days 1 up to Day 3. Subjects were not randomized and discontinued the study early (prior to treatment with ciraparantag) due to PI decision, subject withdraw, AE, or WBCT did not meet required threshold.
Cardiac disorders Supraventricular Tachycardia	0.00% 0/16 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	8.3% 1/12 • Number of events 1 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/5 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.

Other adverse events

Other adverse events
Measure	Placebo n=16 participants at risk Subjects received 20 mg rivaroxaban once daily in the morning on Days 1-3. On Day 3, approximately 4 hours after last rivaroxaban dose, a single IV dose of saline for injection (placebo) was administered.	Ciraparantag 30 mg n=12 participants at risk Subjects received 20 mg rivaroxaban once daily in the morning on Days 1-3. On Day 3, approximately 4 hours after last rivaroxaban dose, a single IV dose of 30 mg ciraparantag was administered.	Ciraparantag 60 mg n=12 participants at risk Subjects received 20 mg rivaroxaban once daily in the morning on Days 1-3. On Day 3, approximately 4 hours after last rivaroxaban dose, a single IV dose of 60 mg ciraparantag was administered.	Ciraparantag 120 mg n=12 participants at risk Subjects received 20 mg rivaroxaban once daily in the morning on Days 1-3. On Day 3, approximately 4 hours after last rivaroxaban dose, a single IV dose of 120 mg ciraparantag was administered.	Ciraparantag 180 mg n=12 participants at risk Subjects received 20 mg rivaroxaban once daily in the morning on Days 1-3. On Day 3, approximately 4 hours after last rivaroxaban dose, a single IV dose of 180 mg ciraparantag was administered.	Enrolled Not Randomized n=5 participants at risk Subjects received 20 mg rivaroxaban once daily in the morning on Days 1 up to Day 3. Subjects were not randomized and discontinued the study early (prior to treatment with ciraparantag) due to PI decision, subject withdraw, AE, or WBCT did not meet required threshold.
Vascular disorders Hot Flush	0.00% 0/16 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	33.3% 4/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	41.7% 5/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/5 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.
Vascular disorders Flushing	0.00% 0/16 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	8.3% 1/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	8.3% 1/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/5 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.
Nervous system disorders Paraesthesia	0.00% 0/16 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	8.3% 1/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	16.7% 2/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/5 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.
Nervous system disorders Dizziness	0.00% 0/16 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	16.7% 2/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/5 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.
Nervous system disorders Dysgeusia	0.00% 0/16 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	8.3% 1/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	8.3% 1/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/5 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.
Nervous system disorders Headache	6.2% 1/16 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	8.3% 1/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	8.3% 1/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/5 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.
General disorders Feeling cold	0.00% 0/16 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	8.3% 1/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	8.3% 1/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	16.7% 2/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/5 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.
General disorders Feeling hot	0.00% 0/16 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	16.7% 2/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/5 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.
General disorders Chest discomfort	0.00% 0/16 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	8.3% 1/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/5 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.
General disorders Injection site discomfort	0.00% 0/16 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	8.3% 1/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/5 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.
General disorders Vessel puncture site bruise	6.2% 1/16 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/5 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.
General disorders Vessel puncture site haematoma	6.2% 1/16 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/5 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.
Gastrointestinal disorders Diarrhea	0.00% 0/16 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	8.3% 1/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/5 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.
Gastrointestinal disorders Dry mouth	0.00% 0/16 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	8.3% 1/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/5 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.
Cardiac disorders Atrioventricular block first degree	0.00% 0/16 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	8.3% 1/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/5 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.
Cardiac disorders Supraventricular tachycardia	0.00% 0/16 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	8.3% 1/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/5 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.
Investigations Alanine aminotransferase increased	0.00% 0/16 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	8.3% 1/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/5 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.
Musculoskeletal and connective tissue disorders Muscle tightness	0.00% 0/16 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	8.3% 1/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/5 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/16 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	8.3% 1/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/5 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.
Metabolism and nutrition disorders Dehydration	6.2% 1/16 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/5 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.
Renal and urinary disorders Renal impairment	6.2% 1/16 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/5 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.
Investigations Electrocardiogram T wave inversion	0.00% 0/16 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/12 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.	20.0% 1/5 • All AEs occurring after the subject signed the informed consent through the last study visit 7 to 10 days following ciraparantag/PBO administration). SAEs occurring up to 30 calendar days post treatment were collected.

Additional Information

Scientific Advisor

Apollo Investment Management

Phone: +352 2088 1301

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place