Trial Outcomes & Findings for Phase 2 Study of Apixaban Reversal by Ciraparantag as Measured by WBCT (NCT NCT03288454)

NCT ID: NCT03288454

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/PBO administration

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 60 participants
• Primary outcome timeframe: Within 1 Hour
• Results posted on: 2025-09-02

Participant Flow

One study site in the US enrolled subjects between August 2017 and August 2019.

60 subjects enrolled; 49 subjects were randomized and eleven subjects were not randomized. Of the 11 subjects not randomized, 9 did not achieve a sufficient level of anticoagulation per protocol and 2 had adverse events (AEs) during apixaban administration causing discontinuation (headache and electrocardiogram abnormal).

Participant milestones

Measure	Placebo Subjects received 10 mg apixaban twice daily on Days 1-3 and once on the morning of Day 4. On Day 4, approximately 3 hours after last apixaban dose, a single IV dose of saline for injection (placebo) was administered.	Ciraparantag 30mg Subjects received 10 mg apixaban twice daily on Days 1-3 and once on the morning of Day 4. On Day 4, approximately 3 hours after last apixaban dose, a single IV dose of 30 mg ciraparantag was administered.	Ciraparantag 60 mg Subjects received 10 mg apixaban twice daily on Days 1-3 and once on the morning of Day 4. On Day 4, approximately 3 hours after last apixaban dose, a single IV dose of 60mg ciraparantag was administered.	Ciraparantag 120 mg Subjects received 10 mg apixaban twice daily on Days 1-3 and once on the morning of Day 4. On Day 4, approximately 3 hours after last apixaban dose, a single IV dose of 120mg ciraparantag was administered.
Overall Study STARTED	13	12	12	12
Overall Study COMPLETED	13	12	12	12
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacodynamic Population included all subjects who received administration of ciraparantag/placebo and provided at least one on-treatment WBCT measurement without protocol deviations with potential to affect these measurements.

Baseline characteristics by cohort

Measure	Placebo n=13 Participants Subjects received 10 mg apixaban twice daily on Days 1-3 and once on the morning of Day 4. On Day 4, approximately 3 hours after last apixaban dose, a single IV dose of saline for injection (placebo) was administered.	Ciraparantag 30 mg n=12 Participants Subjects received 10 mg apixaban twice daily on Days 1-3 and once on the morning of Day 4. On Day 4, approximately 3 hours after last apixaban dose, a single IV dose of 30mg ciraparantag was administered.	Ciraparantag 60 mg n=12 Participants Subjects received 10 mg apixaban twice daily on Days 1-3 and once on the morning of Day 4. On Day 4, approximately 3 hours after last apixaban dose, a single IV dose of 60mg ciraparantag was administered.	Ciraparantag 120 mg n=12 Participants Subjects received 10 mg apixaban twice daily on Days 1-3 and once on the morning of Day 4. On Day 4, approximately 3 hours after last apixaban dose, a single IV dose of 120mg ciraparantag was administered.	Total n=49 Participants Total of all reporting groups
Age, Customized	57.2 years STANDARD_DEVIATION 6.90 • n=13 Participants	55.8 years STANDARD_DEVIATION 5.72 • n=12 Participants	54.4 years STANDARD_DEVIATION 3.87 • n=12 Participants	53.9 years STANDARD_DEVIATION 4.13 • n=12 Participants	55.4 years STANDARD_DEVIATION 5.05 • n=49 Participants
Sex: Female, Male Female	3 Participants n=13 Participants	4 Participants n=12 Participants	3 Participants n=12 Participants	1 Participants n=12 Participants	11 Participants n=49 Participants
Sex: Female, Male Male	10 Participants n=13 Participants	8 Participants n=12 Participants	9 Participants n=12 Participants	11 Participants n=12 Participants	38 Participants n=49 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=13 Participants	2 Participants n=12 Participants	4 Participants n=12 Participants	3 Participants n=12 Participants	14 Participants n=49 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=13 Participants	10 Participants n=12 Participants	8 Participants n=12 Participants	9 Participants n=12 Participants	35 Participants n=49 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=13 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=49 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=13 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=49 Participants
Race (NIH/OMB) Asian	0 Participants n=13 Participants	1 Participants n=12 Participants	1 Participants n=12 Participants	0 Participants n=12 Participants	2 Participants n=49 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=13 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=49 Participants
Race (NIH/OMB) Black or African American	5 Participants n=13 Participants	4 Participants n=12 Participants	3 Participants n=12 Participants	9 Participants n=12 Participants	21 Participants n=49 Participants
Race (NIH/OMB) White	8 Participants n=13 Participants	7 Participants n=12 Participants	8 Participants n=12 Participants	3 Participants n=12 Participants	26 Participants n=49 Participants
Race (NIH/OMB) More than one race	0 Participants n=13 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=49 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=13 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=49 Participants
BMI	27.36 kg/m^2 STANDARD_DEVIATION 3.70 • n=13 Participants	26.22 kg/m^2 STANDARD_DEVIATION 3.03 • n=12 Participants	26.40 kg/m^2 STANDARD_DEVIATION 2.47 • n=12 Participants	26.59 kg/m^2 STANDARD_DEVIATION 2.98 • n=12 Participants	26.66 kg/m^2 STANDARD_DEVIATION 3.03 • n=49 Participants
Baseline Whole Blood Clotting Time (WBCT, manual method)	7.4 minutes STANDARD_DEVIATION 0.29 • n=12 Participants • Pharmacodynamic Population included all subjects who received administration of ciraparantag/placebo and provided at least one on-treatment WBCT measurement without protocol deviations with potential to affect these measurements.	7.7 minutes STANDARD_DEVIATION 0.33 • n=12 Participants • Pharmacodynamic Population included all subjects who received administration of ciraparantag/placebo and provided at least one on-treatment WBCT measurement without protocol deviations with potential to affect these measurements.	7.3 minutes STANDARD_DEVIATION 0.26 • n=12 Participants • Pharmacodynamic Population included all subjects who received administration of ciraparantag/placebo and provided at least one on-treatment WBCT measurement without protocol deviations with potential to affect these measurements.	7.5 minutes STANDARD_DEVIATION 0.33 • n=12 Participants • Pharmacodynamic Population included all subjects who received administration of ciraparantag/placebo and provided at least one on-treatment WBCT measurement without protocol deviations with potential to affect these measurements.	7.5 minutes STANDARD_DEVIATION 0.30 • n=48 Participants • Pharmacodynamic Population included all subjects who received administration of ciraparantag/placebo and provided at least one on-treatment WBCT measurement without protocol deviations with potential to affect these measurements.

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/PBO administration

Outcome measures

Measure	Placebo n=12 Participants Subjects received 10 mg apixaban twice daily on Days 1-3 and once on the morning of Day 4. On Day 4, approximately 3 hours after last apixaban dose, a single IV dose of saline for injection (placebo) was administered.	Ciraparantag 30 mg n=12 Participants Subjects received 10 mg apixaban twice daily on Days 1-3 and once on the morning of Day 4. On Day 4, approximately 3 hours after last apixaban dose, a single IV dose of 30mg ciraparantag was administered.	Ciraparantag 60 mg n=12 Participants Subjects received 10 mg apixaban twice daily on Days 1-3 and once on the morning of Day 4. On Day 4, approximately 3 hours after last apixaban dose, a single IV dose of 60mg ciraparantag was administered.	Ciraparantag 120 mg n=12 Participants Subjects received 10 mg apixaban twice daily on Days 1-3 and once on the morning of Day 4. On Day 4, approximately 3 hours after last apixaban dose, a single IV dose of 120mg ciraparantag was administered.
Subjects Achieving Complete Reversal of Anticoagulation (WBCT is ≤ 110% of Baseline)	2 Participants	9 Participants	12 Participants	12 Participants

PRIMARY outcome

Timeframe: Between 1 and 5 Hours

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 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 5 hours (inclusive) following ciraparantag/placebo administration.

Outcome measures

Measure	Placebo n=12 Participants Subjects received 10 mg apixaban twice daily on Days 1-3 and once on the morning of Day 4. On Day 4, approximately 3 hours after last apixaban dose, a single IV dose of saline for injection (placebo) was administered.	Ciraparantag 30 mg n=12 Participants Subjects received 10 mg apixaban twice daily on Days 1-3 and once on the morning of Day 4. On Day 4, approximately 3 hours after last apixaban dose, a single IV dose of 30mg ciraparantag was administered.	Ciraparantag 60 mg n=12 Participants Subjects received 10 mg apixaban twice daily on Days 1-3 and once on the morning of Day 4. On Day 4, approximately 3 hours after last apixaban dose, a single IV dose of 60mg ciraparantag was administered.	Ciraparantag 120 mg n=12 Participants Subjects received 10 mg apixaban twice daily on Days 1-3 and once on the morning of Day 4. On Day 4, approximately 3 hours after last apixaban dose, a single IV dose of 120mg ciraparantag was administered.
Subjects Achieving Complete and Sustained Reversal of Anticoagulation (WBCT is ≤115% of Baseline)	4 Participants	10 Participants	12 Participants	12 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Ciraparantag 30 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Ciraparantag 60 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Ciraparantag 120 mg

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Enrolled But Not Randomized Participants

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=13 participants at risk Subjects received 10 mg apixaban twice daily on Days 1-3 and once on the morning of Day 4. On Day 4, approximately 3 hours after last apixaban dose, a single IV dose of saline for injection (placebo) was administered.	Ciraparantag 30 mg n=12 participants at risk Subjects received 10 mg apixaban twice daily on Days 1-3 and once on the morning of Day 4. On Day 4, approximately 3 hours after last apixaban dose, a single IV dose of 30mg ciraparantag was administered.	Ciraparantag 60 mg n=12 participants at risk Subjects received 10 mg apixaban twice daily on Days 1-3 and once on the morning of Day 4. On Day 4, approximately 3 hours after last apixaban dose, a single IV dose of 60mg ciraparantag was administered.	Ciraparantag 120 mg n=12 participants at risk Subjects received 10 mg apixaban twice daily on Days 1-3 and once on the morning of Day 4. On Day 4, approximately 3 hours after last apixaban dose, a single IV dose of 120mg ciraparantag was administered.	Enrolled But Not Randomized Participants n=11 participants at risk Subjects received 10 mg apixaban twice daily on Days 1-3 and once on the morning of Day 4. On Day 4, the subjects were not randomized due to WBCT below required threshold or subject discontinued early due to adverse event.
Vascular disorders Hot flush	0.00% 0/13 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/11 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.
General disorders Feeling hot	0.00% 0/13 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.	25.0% 3/12 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/11 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.
General disorders Chills	0.00% 0/13 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/11 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.
General disorders Discomfort	0.00% 0/13 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/11 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.
General disorders Feeling cold	0.00% 0/13 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/11 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.
General disorders Injection site pain	0.00% 0/13 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/11 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.
Gastrointestinal disorders Hypoesthesia oral	0.00% 0/13 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/11 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.
Gastrointestinal disorders Abdominal Pain	0.00% 0/13 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.	9.1% 1/11 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.
Nervous system disorders Dizziness	0.00% 0/13 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.	9.1% 1/11 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.
Gastrointestinal disorders Vomiting	0.00% 0/13 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.	9.1% 1/11 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.
Nervous system disorders Headache	0.00% 0/13 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.	9.1% 1/11 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.
Gastrointestinal disorders Nausea	0.00% 0/13 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.	9.1% 1/11 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/13 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.	9.1% 1/11 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/13 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.	9.1% 1/11 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.
Nervous system disorders Paraesthesia	0.00% 0/13 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.	9.1% 1/11 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.
Injury, poisoning and procedural complications Scratch	0.00% 0/13 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.	9.1% 1/11 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.
Investigations Electrocardiogram abnormal	0.00% 0/13 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.	9.1% 1/11 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.
Musculoskeletal and connective tissue disorders Back pain	7.7% 1/13 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/11 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/13 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/11 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.
Nervous system disorders Somnolence	0.00% 0/13 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/11 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.
Nervous system disorders Sinus headache	0.00% 0/13 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/11 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.
General disorders Fatigue	0.00% 0/13 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/11 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/13 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. 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 (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.	0.00% 0/11 • All AEs occurring after the subject signed the informed consent through the last study visit (follow-up phone call occurring 7 to 10 days following ciraparantag/PBO administration), whether observed by the Investigator or reported by the subject, were collected. SAEs occurring up to 30 calendar days post treatment were collected.

Additional Information

Scientific Advisor

Apollo Investment Management

Phone: +352 2088 1301

Email: rchari@kaiperheathcare.com

Results disclosure agreements

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