Trial Outcomes & Findings for Dose-ranging Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema (NCT NCT04618211)

Results Overview

The primary endpoint of the study was the change of the VAS-3 (3-symptom composite visual analogue scale) score from pre-treatment to 4 hours post-treatment. The VAS-3 was calculated as the mean of the VAS scores of the 3 major HAE symptoms: skin swelling, skin pain, and abdominal pain. The VAS scores of the 3 major HAE symptoms (skin swelling, skin pain, and abdominal pain) could range between 0 (No swelling/No pain) and 100 (Extreme swelling/Excruciating pain)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

74 participants

Primary outcome timeframe

Assessed from pre-treatment to 4 hours post-treatment

Results posted on

2025-12-17

Participant Flow

A total of 89 patients were screened, of which 74 patients were enrolled and randomized to the 3 PHA-022121 cohorts as follows: 25 participants to the 30 mg cohort, 25 participants to the 20 mg cohort, and 24 participants to the 10 mg cohort. From Part I to Part II, participants remained at their randomly assigned dose level. The majority of screen failures were due to inclusion criterion not met.

In Part I, participants in a quiescent state received a single dose of PHA-022121 at the assigned dose (10, 20, or 30 mg) to assess PK and safety. In Part II, participants received 2 single doses of PHA-022121 (10, 20, or 30 mg) and one single dose of placebo to assess efficacy and safety. Each participant administered their randomly assigned dose (either 10, 20, or 30 mg) for each of the 3 qualifying HAE attacks according to 1 of the 3 randomly assigned treatment sequences (crossover design).

Participant milestones

Participant milestones
Measure	PHA-022121 Low Dose - 10 mg Part I: Single low dose of PHA-022121 (10 mg), non-attack state. Part II: 2 single low doses of PHA-022121 (10 mg) and one single dose of placebo in a 3-way crossover design, administered in the following sequence: 1. Low dose / Low dose / Placebo 2. Low dose / Placebo / Low dose 3. Placebo / Low dose / Low dose Participants in Part I assigned to the Low Dose cohort remain in the Low Dose cohort in Part II.	PHA-022121 Medium Dose - 20 mg Part I: Single medium dose of PHA-022121 (20 mg), non-attack state. Part II: 2 single medium doses of PHA-022121 (20 mg) and one single dose of placebo in a 3-way crossover design: 1. Medium dose / Medium dose / Placebo 2. Medium dose / Placebo / Medium dose 3. Placebo / Medium dose / Medium dose Participants in Part I assigned to the Medium Dose cohort remain in the Medium Dose cohort in Part II.	PHA-022121 High Dose - 30 mg Part I: Single high dose of PHA-022121 (30 mg), non-attack state. Part II: 2 single high doses of PHA-022121 (30 mg) and one single dose of placebo in a 3-way crossover design: 1. High dose / High dose / Placebo 2. High dose / Placebo / High dose 3. Placebo / High dose / High dose Participants in Part I assigned to the High Dose cohort remain in the High Dose cohort in Part II.
Part I (Non-Attack, Safety) STARTED	24	25	25
Part I (Non-Attack, Safety) COMPLETED	24	24	25
Part I (Non-Attack, Safety) NOT COMPLETED	0	1	0
Part II (Self-administration, Efficacy) STARTED	24	24	25
Part II (Self-administration, Efficacy) Attack 1 - PHA-022121	16	13	17
Part II (Self-administration, Efficacy) Attack 1 - Placebo	6	6	6
Part II (Self-administration, Efficacy) Attack 2 - PHA-022121	12	8	12
Part II (Self-administration, Efficacy) Attack 2 - Placebo	7	8	7
Part II (Self-administration, Efficacy) Attack 3 - PHA-022121	11	10	10
Part II (Self-administration, Efficacy) Attack 3 - Placebo	7	3	6
Part II (Self-administration, Efficacy) COMPLETED	16	12	12
Part II (Self-administration, Efficacy) NOT COMPLETED	8	12	13

Reasons for withdrawal

Reasons for withdrawal
Measure	PHA-022121 Low Dose - 10 mg Part I: Single low dose of PHA-022121 (10 mg), non-attack state. Part II: 2 single low doses of PHA-022121 (10 mg) and one single dose of placebo in a 3-way crossover design, administered in the following sequence: 1. Low dose / Low dose / Placebo 2. Low dose / Placebo / Low dose 3. Placebo / Low dose / Low dose Participants in Part I assigned to the Low Dose cohort remain in the Low Dose cohort in Part II.	PHA-022121 Medium Dose - 20 mg Part I: Single medium dose of PHA-022121 (20 mg), non-attack state. Part II: 2 single medium doses of PHA-022121 (20 mg) and one single dose of placebo in a 3-way crossover design: 1. Medium dose / Medium dose / Placebo 2. Medium dose / Placebo / Medium dose 3. Placebo / Medium dose / Medium dose Participants in Part I assigned to the Medium Dose cohort remain in the Medium Dose cohort in Part II.	PHA-022121 High Dose - 30 mg Part I: Single high dose of PHA-022121 (30 mg), non-attack state. Part II: 2 single high doses of PHA-022121 (30 mg) and one single dose of placebo in a 3-way crossover design: 1. High dose / High dose / Placebo 2. High dose / Placebo / High dose 3. Placebo / High dose / High dose Participants in Part I assigned to the High Dose cohort remain in the High Dose cohort in Part II.
Part I (Non-Attack, Safety) Withdrawal by Subject	0	1	0
Part II (Self-administration, Efficacy) Withdrawal by Subject	2	3	5
Part II (Self-administration, Efficacy) Participants Met Primary Analysis Criteria	6	9	8

Baseline Characteristics

Dose-ranging Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PHA-022121 Low Dose - 10 mg n=24 Participants Part I: Single low dose of PHA-022121 (10 mg), non-attack state.	PHA-022121 Medium Dose - 20 mg n=25 Participants Part I: Single medium dose of PHA-022121 (20 mg), non-attack state.	PHA-022121 High Dose - 30 mg n=25 Participants Part I: Single high dose of PHA-022121 (30 mg), non-attack state.	Total n=74 Participants Total of all reporting groups
Age, Continuous	42.9 years STANDARD_DEVIATION 14.15 • n=6 Participants	45.7 years STANDARD_DEVIATION 13.89 • n=5 Participants	41.4 years STANDARD_DEVIATION 15.38 • n=5 Participants	43.3 years STANDARD_DEVIATION 14.41 • n=122 Participants
Age, Customized Adults (18-64 years)	22 Participants n=6 Participants	24 Participants n=5 Participants	23 Participants n=5 Participants	69 Participants n=122 Participants
Age, Customized From 65-84 years	2 Participants n=6 Participants	1 Participants n=5 Participants	2 Participants n=5 Participants	5 Participants n=122 Participants
Sex: Female, Male Female	17 Participants n=6 Participants	17 Participants n=5 Participants	15 Participants n=5 Participants	49 Participants n=122 Participants
Sex: Female, Male Male	7 Participants n=6 Participants	8 Participants n=5 Participants	10 Participants n=5 Participants	25 Participants n=122 Participants
Race/Ethnicity, Customized White	22 Participants n=6 Participants	24 Participants n=5 Participants	25 Participants n=5 Participants	71 Participants n=122 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants	1 Participants n=122 Participants
Race/Ethnicity, Customized Asian	1 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants	1 Participants n=122 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=122 Participants
Race/Ethnicity, Customized Other	0 Participants n=6 Participants	1 Participants n=5 Participants	0 Participants n=5 Participants	1 Participants n=122 Participants
Race/Ethnicity, Customized Hispanic or Latino	3 Participants n=6 Participants	2 Participants n=5 Participants	0 Participants n=5 Participants	5 Participants n=122 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	18 Participants n=6 Participants	22 Participants n=5 Participants	24 Participants n=5 Participants	64 Participants n=122 Participants
Race/Ethnicity, Customized Not Reported	3 Participants n=6 Participants	1 Participants n=5 Participants	1 Participants n=5 Participants	5 Participants n=122 Participants

PRIMARY outcome

Timeframe: Assessed from pre-treatment to 4 hours post-treatment

Population: Part I efficacy data not collected, consistent with and pre-specified in the study protocol. Includes all participants with evaluable data who completed the relevant assessment time point.

The primary endpoint of the study was the change of the VAS-3 (3-symptom composite visual analogue scale) score from pre-treatment to 4 hours post-treatment. The VAS-3 was calculated as the mean of the VAS scores of the 3 major HAE symptoms: skin swelling, skin pain, and abdominal pain. The VAS scores of the 3 major HAE symptoms (skin swelling, skin pain, and abdominal pain) could range between 0 (No swelling/No pain) and 100 (Extreme swelling/Excruciating pain)

Outcome measures

Outcome measures
Measure	PHA-022121 Low Dose - 10 mg n=21 Participants Part II: 2 single low doses of PHA-022121 (10 mg) and one single dose of placebo in a 3-way crossover design: 1. Low dose / Low dose / Placebo 2. Low dose / Placebo / Low dose 3. Placebo / Low dose / Low dose Part II efficacy data utilized for the analysis.	PHA-022121 Medium Dose - 20 mg n=16 Participants Part II: 2 single medium doses of PHA-022121 (20 mg) and one single dose of placebo in a 3-way crossover design: 1. Medium dose / Medium dose / Placebo 2. Medium dose / Placebo / Medium dose 3. Placebo / Medium dose / Medium dose Part II efficacy data utilized for the analysis.	PHA-022121 High Dose - 30 mg n=20 Participants Part II: 2 single high doses of PHA-022121 (30 mg) and one single dose of placebo in a 3-way crossover design: 1. High dose / High dose / Placebo 2. High dose / Placebo / High dose 3. Placebo / High dose / High dose Part II efficacy data utilized for the analysis.	Placebo n=51 Participants Part II: 2 single high doses of PHA-022121 (10, 20, or 30 mg) and one single dose of placebo in a 3-way crossover design: 1. PHA-022121 dose / PHA-022121 dose / Placebo 2. PHA-022121 dose / Placebo / PHA-022121 dose 3. Placebo / PHA-022121 dose / PHA-022121 dose Part II efficacy data utilized for the analysis.
Change of the 3-symptom Composite Visual Analogue Scale (VAS-3) Score From Pre-treatment to 4 Hours Post-treatment	-14.83 Score on a scale Standard Error 1.833	-13.10 Score on a scale Standard Error 2.111	-14.37 Score on a scale Standard Error 1.975	1.92 Score on a scale Standard Error 1.596

SECONDARY outcome

Timeframe: Assessed from pre-treatment to 48-hours post-treatment

Population: Part I efficacy data not collected, consistent with and pre-specified in the study protocol. Includes all participants with evaluable data who completed the relevant assessment time point.

VAS-3 scores range between 0 and 100.

Outcome measures

Outcome measures
Measure	PHA-022121 Low Dose - 10 mg n=21 Participants Part II: 2 single low doses of PHA-022121 (10 mg) and one single dose of placebo in a 3-way crossover design: 1. Low dose / Low dose / Placebo 2. Low dose / Placebo / Low dose 3. Placebo / Low dose / Low dose Part II efficacy data utilized for the analysis.	PHA-022121 Medium Dose - 20 mg n=16 Participants Part II: 2 single medium doses of PHA-022121 (20 mg) and one single dose of placebo in a 3-way crossover design: 1. Medium dose / Medium dose / Placebo 2. Medium dose / Placebo / Medium dose 3. Placebo / Medium dose / Medium dose Part II efficacy data utilized for the analysis.	PHA-022121 High Dose - 30 mg n=20 Participants Part II: 2 single high doses of PHA-022121 (30 mg) and one single dose of placebo in a 3-way crossover design: 1. High dose / High dose / Placebo 2. High dose / Placebo / High dose 3. Placebo / High dose / High dose Part II efficacy data utilized for the analysis.	Placebo n=51 Participants Part II: 2 single high doses of PHA-022121 (10, 20, or 30 mg) and one single dose of placebo in a 3-way crossover design: 1. PHA-022121 dose / PHA-022121 dose / Placebo 2. PHA-022121 dose / Placebo / PHA-022121 dose 3. Placebo / PHA-022121 dose / PHA-022121 dose Part II efficacy data utilized for the analysis.
Time to Onset of Symptom Relief by ≥30% Reduction in Visual Analogue Scale (VAS-3) Composite Score From the Pre-treatment Score	2.1 Hours Interval 1.5 to 2.9	2.7 Hours Interval 1.9 to 3.5	2.5 Hours Interval 1.9 to 3.8	8.0 Hours Interval 7.6 to 48.0

SECONDARY outcome

Timeframe: Assessed from pre-treatment to 48 hours post-treatment

Population: Part I efficacy data not collected, consistent with and pre-specified in the study protocol. Includes all participants with evaluable data who completed the relevant assessment time point.

VAS scores range between 0 and 100. Almost complete symptom relief is defined as all 3 individual VAS scores of the VAS-3 having a value \< 10. Complete symptom relief is defined as all 3 individual VAS scores are of the VAS-3 having a value of 0.

Outcome measures

Outcome measures
Measure	PHA-022121 Low Dose - 10 mg n=21 Participants Part II: 2 single low doses of PHA-022121 (10 mg) and one single dose of placebo in a 3-way crossover design: 1. Low dose / Low dose / Placebo 2. Low dose / Placebo / Low dose 3. Placebo / Low dose / Low dose Part II efficacy data utilized for the analysis.	PHA-022121 Medium Dose - 20 mg n=16 Participants Part II: 2 single medium doses of PHA-022121 (20 mg) and one single dose of placebo in a 3-way crossover design: 1. Medium dose / Medium dose / Placebo 2. Medium dose / Placebo / Medium dose 3. Placebo / Medium dose / Medium dose Part II efficacy data utilized for the analysis.	PHA-022121 High Dose - 30 mg n=20 Participants Part II: 2 single high doses of PHA-022121 (30 mg) and one single dose of placebo in a 3-way crossover design: 1. High dose / High dose / Placebo 2. High dose / Placebo / High dose 3. Placebo / High dose / High dose Part II efficacy data utilized for the analysis.	Placebo n=51 Participants Part II: 2 single high doses of PHA-022121 (10, 20, or 30 mg) and one single dose of placebo in a 3-way crossover design: 1. PHA-022121 dose / PHA-022121 dose / Placebo 2. PHA-022121 dose / Placebo / PHA-022121 dose 3. Placebo / PHA-022121 dose / PHA-022121 dose Part II efficacy data utilized for the analysis.
Time to Onset of Almost Complete or Complete Symptom Relief by Visual Analogue Scale (VAS-3)	5.8 Hours Interval 3.6 to 7.5	20.0 Hours Interval 4.5 to 20.0	20.0 Hours Interval 6.0 to 20.1	42.0 Hours Interval 22.0 to 48.0

SECONDARY outcome

Timeframe: Assessed from pre-treatment to 48 hours post-treatment

Population: Part I efficacy data not collected, consistent with and pre-specified in the study protocol. Includes all participants with evaluable data who completed the relevant assessment time point.

Time to a ≥50% reduction in VAS-3 composite score from the pre-treatment score.

Outcome measures

Outcome measures
Measure	PHA-022121 Low Dose - 10 mg n=21 Participants Part II: 2 single low doses of PHA-022121 (10 mg) and one single dose of placebo in a 3-way crossover design: 1. Low dose / Low dose / Placebo 2. Low dose / Placebo / Low dose 3. Placebo / Low dose / Low dose Part II efficacy data utilized for the analysis.	PHA-022121 Medium Dose - 20 mg n=16 Participants Part II: 2 single medium doses of PHA-022121 (20 mg) and one single dose of placebo in a 3-way crossover design: 1. Medium dose / Medium dose / Placebo 2. Medium dose / Placebo / Medium dose 3. Placebo / Medium dose / Medium dose Part II efficacy data utilized for the analysis.	PHA-022121 High Dose - 30 mg n=20 Participants Part II: 2 single high doses of PHA-022121 (30 mg) and one single dose of placebo in a 3-way crossover design: 1. High dose / High dose / Placebo 2. High dose / Placebo / High dose 3. Placebo / High dose / High dose Part II efficacy data utilized for the analysis.	Placebo n=51 Participants Part II: 2 single high doses of PHA-022121 (10, 20, or 30 mg) and one single dose of placebo in a 3-way crossover design: 1. PHA-022121 dose / PHA-022121 dose / Placebo 2. PHA-022121 dose / Placebo / PHA-022121 dose 3. Placebo / PHA-022121 dose / PHA-022121 dose Part II efficacy data utilized for the analysis.
Time to a ≥50% Reduction in VAS-3 Composite Score From the Pre-treatment Score	3.3 Hours Interval 2.4 to 3.9	4.0 Hours Interval 2.9 to 6.0	4.0 Hours Interval 3.3 to 5.8	22.8 Hours Interval 20.0 to 24.1

SECONDARY outcome

Timeframe: Pre-treatment and 4 hours post-treatment

Population: Part I efficacy data not collected, consistent with and pre-specified in the study protocol. Includes all participants with evaluable data who completed the relevant assessment time point.

MSCS scores range between 0 and 3. A higher score means a worse outcome.

Outcome measures

Outcome measures
Measure	PHA-022121 Low Dose - 10 mg n=21 Participants Part II: 2 single low doses of PHA-022121 (10 mg) and one single dose of placebo in a 3-way crossover design: 1. Low dose / Low dose / Placebo 2. Low dose / Placebo / Low dose 3. Placebo / Low dose / Low dose Part II efficacy data utilized for the analysis.	PHA-022121 Medium Dose - 20 mg n=16 Participants Part II: 2 single medium doses of PHA-022121 (20 mg) and one single dose of placebo in a 3-way crossover design: 1. Medium dose / Medium dose / Placebo 2. Medium dose / Placebo / Medium dose 3. Placebo / Medium dose / Medium dose Part II efficacy data utilized for the analysis.	PHA-022121 High Dose - 30 mg n=20 Participants Part II: 2 single high doses of PHA-022121 (30 mg) and one single dose of placebo in a 3-way crossover design: 1. High dose / High dose / Placebo 2. High dose / Placebo / High dose 3. Placebo / High dose / High dose Part II efficacy data utilized for the analysis.	Placebo n=51 Participants Part II: 2 single high doses of PHA-022121 (10, 20, or 30 mg) and one single dose of placebo in a 3-way crossover design: 1. PHA-022121 dose / PHA-022121 dose / Placebo 2. PHA-022121 dose / Placebo / PHA-022121 dose 3. Placebo / PHA-022121 dose / PHA-022121 dose Part II efficacy data utilized for the analysis.
Change in the Mean Symptom Complex Severity (MSCS) Score From Pre-treatment to 4 Hours Post-treatment	-1.08 Score on a scale Interval -1.33 to -0.83	-0.91 Score on a scale Interval -1.19 to -0.62	-0.68 Score on a scale Interval -0.95 to -0.4	-0.29 Score on a scale Interval -0.51 to -0.08

SECONDARY outcome

Timeframe: 4 hours post-treatment

Population: Part I efficacy data not collected, consistent with and pre-specified in the study protocol. Includes all participants with evaluable data who completed the relevant assessment time point.

TOS range between -100 and 100. A positive score indicates improvement, a score of 0 indicates no change, and a negative score indicates worsening compared to pre-treatment.

Outcome measures

Outcome measures
Measure	PHA-022121 Low Dose - 10 mg n=21 Participants Part II: 2 single low doses of PHA-022121 (10 mg) and one single dose of placebo in a 3-way crossover design: 1. Low dose / Low dose / Placebo 2. Low dose / Placebo / Low dose 3. Placebo / Low dose / Low dose Part II efficacy data utilized for the analysis.	PHA-022121 Medium Dose - 20 mg n=16 Participants Part II: 2 single medium doses of PHA-022121 (20 mg) and one single dose of placebo in a 3-way crossover design: 1. Medium dose / Medium dose / Placebo 2. Medium dose / Placebo / Medium dose 3. Placebo / Medium dose / Medium dose Part II efficacy data utilized for the analysis.	PHA-022121 High Dose - 30 mg n=20 Participants Part II: 2 single high doses of PHA-022121 (30 mg) and one single dose of placebo in a 3-way crossover design: 1. High dose / High dose / Placebo 2. High dose / Placebo / High dose 3. Placebo / High dose / High dose Part II efficacy data utilized for the analysis.	Placebo n=51 Participants Part II: 2 single high doses of PHA-022121 (10, 20, or 30 mg) and one single dose of placebo in a 3-way crossover design: 1. PHA-022121 dose / PHA-022121 dose / Placebo 2. PHA-022121 dose / Placebo / PHA-022121 dose 3. Placebo / PHA-022121 dose / PHA-022121 dose Part II efficacy data utilized for the analysis.
Treatment Outcome Score (TOS) at 4 Hours Post-treatment	60.52 Score on a scale Interval 41.74 to 79.29	59.08 Score on a scale Interval 37.58 to 80.57	67.44 Score on a scale Interval 47.15 to 87.74	-3.62 Score on a scale Interval -19.68 to 12.45

SECONDARY outcome

Timeframe: Within 48 hours post-treatment

Population: Part I efficacy data not collected, consistent with and pre-specified in the study protocol. Includes all participants with evaluable data who completed the relevant assessment time point.

Time to onset of primary symptom relief assessed by a 30% reduction in the VAS for the primary symptom within 48 hours post-treatment

Outcome measures

Outcome measures
Measure	PHA-022121 Low Dose - 10 mg n=21 Participants Part II: 2 single low doses of PHA-022121 (10 mg) and one single dose of placebo in a 3-way crossover design: 1. Low dose / Low dose / Placebo 2. Low dose / Placebo / Low dose 3. Placebo / Low dose / Low dose Part II efficacy data utilized for the analysis.	PHA-022121 Medium Dose - 20 mg n=16 Participants Part II: 2 single medium doses of PHA-022121 (20 mg) and one single dose of placebo in a 3-way crossover design: 1. Medium dose / Medium dose / Placebo 2. Medium dose / Placebo / Medium dose 3. Placebo / Medium dose / Medium dose Part II efficacy data utilized for the analysis.	PHA-022121 High Dose - 30 mg n=20 Participants Part II: 2 single high doses of PHA-022121 (30 mg) and one single dose of placebo in a 3-way crossover design: 1. High dose / High dose / Placebo 2. High dose / Placebo / High dose 3. Placebo / High dose / High dose Part II efficacy data utilized for the analysis.	Placebo n=51 Participants Part II: 2 single high doses of PHA-022121 (10, 20, or 30 mg) and one single dose of placebo in a 3-way crossover design: 1. PHA-022121 dose / PHA-022121 dose / Placebo 2. PHA-022121 dose / Placebo / PHA-022121 dose 3. Placebo / PHA-022121 dose / PHA-022121 dose Part II efficacy data utilized for the analysis.
Time to Onset of Primary Symptom Relief Assessed by a 30% Reduction in the VAS for the Primary Symptom	2.0 Hours Interval 1.4 to 2.4	3.0 Hours Interval 1.9 to 4.1	2.9 Hours Interval 1.9 to 3.9	23.3 Hours Interval 6.1 to Insufficient number of participants with events.

SECONDARY outcome

Timeframe: Assessed at 12 hours post study drug treatment

Population: Part I efficacy data not collected, consistent with and pre-specified in the study protocol. Includes all participants with evaluable data who completed the relevant assessment time point.

Proportion of blinded study drug treated attacks requiring HAE rescue medication within 12 hours post-treatment.

Outcome measures

Outcome measures
Measure	PHA-022121 Low Dose - 10 mg n=37 Number of Treated Attacks Part II: 2 single low doses of PHA-022121 (10 mg) and one single dose of placebo in a 3-way crossover design: 1. Low dose / Low dose / Placebo 2. Low dose / Placebo / Low dose 3. Placebo / Low dose / Low dose Part II efficacy data utilized for the analysis.	PHA-022121 Medium Dose - 20 mg n=28 Number of Treated Attacks Part II: 2 single medium doses of PHA-022121 (20 mg) and one single dose of placebo in a 3-way crossover design: 1. Medium dose / Medium dose / Placebo 2. Medium dose / Placebo / Medium dose 3. Placebo / Medium dose / Medium dose Part II efficacy data utilized for the analysis.	PHA-022121 High Dose - 30 mg n=31 Number of Treated Attacks Part II: 2 single high doses of PHA-022121 (30 mg) and one single dose of placebo in a 3-way crossover design: 1. High dose / High dose / Placebo 2. High dose / Placebo / High dose 3. Placebo / High dose / High dose Part II efficacy data utilized for the analysis.	Placebo n=51 Number of Treated Attacks Part II: 2 single high doses of PHA-022121 (10, 20, or 30 mg) and one single dose of placebo in a 3-way crossover design: 1. PHA-022121 dose / PHA-022121 dose / Placebo 2. PHA-022121 dose / Placebo / PHA-022121 dose 3. Placebo / PHA-022121 dose / PHA-022121 dose Part II efficacy data utilized for the analysis.
Proportion of Study Drug Treated Attacks Requiring HAE Rescue Medication Within 12 Hours.	7 Attacks requiring HAE rescue medication	3 Attacks requiring HAE rescue medication	2 Attacks requiring HAE rescue medication	31 Attacks requiring HAE rescue medication

SECONDARY outcome

Timeframe: Assessed at 48 hours post study drug treatment

Population: Part I efficacy data not collected, consistent with and pre-specified in the study protocol. Includes all participants with evaluable data who completed the relevant assessment time point. Medians are as follows: Low Dose 10 mg - NA (

The proportion of treated attacks with first use of HAE rescue medication within 48 hours post-treatment with PHA-022121.

Outcome measures

Outcome measures
Measure	PHA-022121 Low Dose - 10 mg n=21 Participants Part II: 2 single low doses of PHA-022121 (10 mg) and one single dose of placebo in a 3-way crossover design: 1. Low dose / Low dose / Placebo 2. Low dose / Placebo / Low dose 3. Placebo / Low dose / Low dose Part II efficacy data utilized for the analysis.	PHA-022121 Medium Dose - 20 mg n=16 Participants Part II: 2 single medium doses of PHA-022121 (20 mg) and one single dose of placebo in a 3-way crossover design: 1. Medium dose / Medium dose / Placebo 2. Medium dose / Placebo / Medium dose 3. Placebo / Medium dose / Medium dose Part II efficacy data utilized for the analysis.	PHA-022121 High Dose - 30 mg n=20 Participants Part II: 2 single high doses of PHA-022121 (30 mg) and one single dose of placebo in a 3-way crossover design: 1. High dose / High dose / Placebo 2. High dose / Placebo / High dose 3. Placebo / High dose / High dose Part II efficacy data utilized for the analysis.	Placebo n=51 Participants Part II: 2 single high doses of PHA-022121 (10, 20, or 30 mg) and one single dose of placebo in a 3-way crossover design: 1. PHA-022121 dose / PHA-022121 dose / Placebo 2. PHA-022121 dose / Placebo / PHA-022121 dose 3. Placebo / PHA-022121 dose / PHA-022121 dose Part II efficacy data utilized for the analysis.
Time to First HAE Rescue Medication Use for Study Drug-treated Attacks Within 48 Hours Post-treatment	NA Hours Insufficient number of participants with events.	NA Hours Insufficient number of participants with events.	NA Hours Insufficient number of participants with events.	6.0 Hours Interval 4.4 to 13.1

SECONDARY outcome

Timeframe: Within 48 hours post treatment

Population: Part I efficacy data not collected, consistent with and pre-specified in the study protocol. Includes all participants with evaluable data who completed the relevant assessment time point.

Time to change in the VAS score for Skin Pain Score - 30% reduction within 48-hours post-treatment. VAS-3 scores range between 0 and 100. A larger reduction means a better outcome.

Outcome measures

Outcome measures
Measure	PHA-022121 Low Dose - 10 mg n=17 Participants Part II: 2 single low doses of PHA-022121 (10 mg) and one single dose of placebo in a 3-way crossover design: 1. Low dose / Low dose / Placebo 2. Low dose / Placebo / Low dose 3. Placebo / Low dose / Low dose Part II efficacy data utilized for the analysis.	PHA-022121 Medium Dose - 20 mg n=10 Participants Part II: 2 single medium doses of PHA-022121 (20 mg) and one single dose of placebo in a 3-way crossover design: 1. Medium dose / Medium dose / Placebo 2. Medium dose / Placebo / Medium dose 3. Placebo / Medium dose / Medium dose Part II efficacy data utilized for the analysis.	PHA-022121 High Dose - 30 mg n=17 Participants Part II: 2 single high doses of PHA-022121 (30 mg) and one single dose of placebo in a 3-way crossover design: 1. High dose / High dose / Placebo 2. High dose / Placebo / High dose 3. Placebo / High dose / High dose Part II efficacy data utilized for the analysis.	Placebo n=34 Participants Part II: 2 single high doses of PHA-022121 (10, 20, or 30 mg) and one single dose of placebo in a 3-way crossover design: 1. PHA-022121 dose / PHA-022121 dose / Placebo 2. PHA-022121 dose / Placebo / PHA-022121 dose 3. Placebo / PHA-022121 dose / PHA-022121 dose Part II efficacy data utilized for the analysis.
Time to Change in the VAS Score for Skin Pain Score - 30% Reduction	2.9 Hours Interval 1.9 to 5.7	3.4 Hours Interval 1.9 to 6.0	2.7 Hours Interval 1.9 to 3.9	22.8 Hours Interval 8.7 to Insufficient number of participants with events.

SECONDARY outcome

Timeframe: 24 hours post-treatment

Population: Part I efficacy data not collected, consistent with and pre-specified in the study protocol. Includes all participants with evaluable data who completed the relevant assessment time point.

Change in the Mean Symptom Complex Severity (MSCS) score from pre-treatment to 24 hours post-treatment. A lower MSCS score indicates a better outcome.

Outcome measures

Outcome measures
Measure	PHA-022121 Low Dose - 10 mg n=21 Participants Part II: 2 single low doses of PHA-022121 (10 mg) and one single dose of placebo in a 3-way crossover design: 1. Low dose / Low dose / Placebo 2. Low dose / Placebo / Low dose 3. Placebo / Low dose / Low dose Part II efficacy data utilized for the analysis.	PHA-022121 Medium Dose - 20 mg n=16 Participants Part II: 2 single medium doses of PHA-022121 (20 mg) and one single dose of placebo in a 3-way crossover design: 1. Medium dose / Medium dose / Placebo 2. Medium dose / Placebo / Medium dose 3. Placebo / Medium dose / Medium dose Part II efficacy data utilized for the analysis.	PHA-022121 High Dose - 30 mg n=20 Participants Part II: 2 single high doses of PHA-022121 (30 mg) and one single dose of placebo in a 3-way crossover design: 1. High dose / High dose / Placebo 2. High dose / Placebo / High dose 3. Placebo / High dose / High dose Part II efficacy data utilized for the analysis.	Placebo n=51 Participants Part II: 2 single high doses of PHA-022121 (10, 20, or 30 mg) and one single dose of placebo in a 3-way crossover design: 1. PHA-022121 dose / PHA-022121 dose / Placebo 2. PHA-022121 dose / Placebo / PHA-022121 dose 3. Placebo / PHA-022121 dose / PHA-022121 dose Part II efficacy data utilized for the analysis.
Change in Mean Symptom Complex Severity Score From Pre-treatment to 24 Hours Post-treatment	-1.65 Score on a scale Standard Error 0.117	-1.50 Score on a scale Standard Error 0.123	-1.68 Score on a scale Standard Error 0.122	-1.20 Score on a scale Standard Error 0.163

SECONDARY outcome

Timeframe: Assessed within 24 hours post treatment

Population: Part I efficacy data not collected, consistent with and pre-specified in the study protocol. Includes all participants with evaluable data who completed the relevant assessment time point.

Treatment outcome score at 24 hours post-treatment. A higher score indicates improvement.

Outcome measures

Outcome measures
Measure	PHA-022121 Low Dose - 10 mg n=21 Participants Part II: 2 single low doses of PHA-022121 (10 mg) and one single dose of placebo in a 3-way crossover design: 1. Low dose / Low dose / Placebo 2. Low dose / Placebo / Low dose 3. Placebo / Low dose / Low dose Part II efficacy data utilized for the analysis.	PHA-022121 Medium Dose - 20 mg n=16 Participants Part II: 2 single medium doses of PHA-022121 (20 mg) and one single dose of placebo in a 3-way crossover design: 1. Medium dose / Medium dose / Placebo 2. Medium dose / Placebo / Medium dose 3. Placebo / Medium dose / Medium dose Part II efficacy data utilized for the analysis.	PHA-022121 High Dose - 30 mg n=20 Participants Part II: 2 single high doses of PHA-022121 (30 mg) and one single dose of placebo in a 3-way crossover design: 1. High dose / High dose / Placebo 2. High dose / Placebo / High dose 3. Placebo / High dose / High dose Part II efficacy data utilized for the analysis.	Placebo n=51 Participants Part II: 2 single high doses of PHA-022121 (10, 20, or 30 mg) and one single dose of placebo in a 3-way crossover design: 1. PHA-022121 dose / PHA-022121 dose / Placebo 2. PHA-022121 dose / Placebo / PHA-022121 dose 3. Placebo / PHA-022121 dose / PHA-022121 dose Part II efficacy data utilized for the analysis.
TOS at 24 Hours Post-treatment	94.44 Score on a scale Standard Deviation 21.183	93.60 Score on a scale Standard Deviation 21.190	94.44 Score on a scale Standard Deviation 16.013	76.92 Score on a scale Standard Deviation 38.813

SECONDARY outcome

Timeframe: 48 hours post-treatment

Population: Part I efficacy data not collected, consistent with and pre-specified in the study protocol. Includes all participants with evaluable data who completed the relevant assessment time point.

MMRM analysis of Treatment Satisfaction Questionnaire for Medication (TSQM) at 48 hours post-treatment. The 11-item TSQM (version II) evaluated participant treatment satisfaction with the medication for the following scales: effectiveness, side effects, convenience, and overall satisfaction Scale scores were transformed into scores ranging from 0 to 100 and could be used to calculate a total composite score, a higher score indicating greater satisfaction.

Outcome measures

Outcome measures
Measure	PHA-022121 Low Dose - 10 mg n=21 Participants Part II: 2 single low doses of PHA-022121 (10 mg) and one single dose of placebo in a 3-way crossover design: 1. Low dose / Low dose / Placebo 2. Low dose / Placebo / Low dose 3. Placebo / Low dose / Low dose Part II efficacy data utilized for the analysis.	PHA-022121 Medium Dose - 20 mg n=16 Participants Part II: 2 single medium doses of PHA-022121 (20 mg) and one single dose of placebo in a 3-way crossover design: 1. Medium dose / Medium dose / Placebo 2. Medium dose / Placebo / Medium dose 3. Placebo / Medium dose / Medium dose Part II efficacy data utilized for the analysis.	PHA-022121 High Dose - 30 mg n=20 Participants Part II: 2 single high doses of PHA-022121 (30 mg) and one single dose of placebo in a 3-way crossover design: 1. High dose / High dose / Placebo 2. High dose / Placebo / High dose 3. Placebo / High dose / High dose Part II efficacy data utilized for the analysis.	Placebo n=51 Participants Part II: 2 single high doses of PHA-022121 (10, 20, or 30 mg) and one single dose of placebo in a 3-way crossover design: 1. PHA-022121 dose / PHA-022121 dose / Placebo 2. PHA-022121 dose / Placebo / PHA-022121 dose 3. Placebo / PHA-022121 dose / PHA-022121 dose Part II efficacy data utilized for the analysis.
Treatment Satisfaction Questionnaire for Medication Scores at 48 Hours Post-treatment - Effectiveness Domain Score	79.17 Score on a scale Standard Deviation 23.179	70.45 Score on a scale Standard Deviation 30.290	72.92 Score on a scale Standard Deviation 23.085	65.38 Score on a scale Standard Deviation 23.532

SECONDARY outcome

Timeframe: Within 48 hours post-treatment

Population: Part I efficacy data not collected, consistent with and pre-specified in the study protocol. Includes all participants with evaluable data who completed the relevant assessment time point.

Time to Onset of Primary Symptom Relief by 50% Reduction in VAS Score within 48 hours post-treatment. VAS-3 scores range between 0 and 100. A larger reduction means a better outcome.

Outcome measures

Outcome measures
Measure	PHA-022121 Low Dose - 10 mg n=21 Participants Part II: 2 single low doses of PHA-022121 (10 mg) and one single dose of placebo in a 3-way crossover design: 1. Low dose / Low dose / Placebo 2. Low dose / Placebo / Low dose 3. Placebo / Low dose / Low dose Part II efficacy data utilized for the analysis.	PHA-022121 Medium Dose - 20 mg n=16 Participants Part II: 2 single medium doses of PHA-022121 (20 mg) and one single dose of placebo in a 3-way crossover design: 1. Medium dose / Medium dose / Placebo 2. Medium dose / Placebo / Medium dose 3. Placebo / Medium dose / Medium dose Part II efficacy data utilized for the analysis.	PHA-022121 High Dose - 30 mg n=20 Participants Part II: 2 single high doses of PHA-022121 (30 mg) and one single dose of placebo in a 3-way crossover design: 1. High dose / High dose / Placebo 2. High dose / Placebo / High dose 3. Placebo / High dose / High dose Part II efficacy data utilized for the analysis.	Placebo n=51 Participants Part II: 2 single high doses of PHA-022121 (10, 20, or 30 mg) and one single dose of placebo in a 3-way crossover design: 1. PHA-022121 dose / PHA-022121 dose / Placebo 2. PHA-022121 dose / Placebo / PHA-022121 dose 3. Placebo / PHA-022121 dose / PHA-022121 dose Part II efficacy data utilized for the analysis.
Time to Onset of Primary Symptom Relief by 50% Reduction in VAS Score	2.9 Hours Interval 2.4 to 3.9	4.5 Hours Interval 2.9 to 8.5	4.0 Hours Interval 2.5 to 5.8	22.8 Hours Interval 5.8 to 24.1

SECONDARY outcome

Timeframe: Assessed at 24 hours post-study drug treatment

Population: Part I efficacy data not collected, consistent with and pre-specified in the study protocol. Includes all participants with evaluable data who completed the relevant assessment time point.

Qualifying attacks treated with study drug may use approved rescue medication if no symptom relief within 4 hours has been experienced.

Outcome measures

Outcome measures
Measure	PHA-022121 Low Dose - 10 mg n=21 Participants Part II: 2 single low doses of PHA-022121 (10 mg) and one single dose of placebo in a 3-way crossover design: 1. Low dose / Low dose / Placebo 2. Low dose / Placebo / Low dose 3. Placebo / Low dose / Low dose Part II efficacy data utilized for the analysis.	PHA-022121 Medium Dose - 20 mg n=16 Participants Part II: 2 single medium doses of PHA-022121 (20 mg) and one single dose of placebo in a 3-way crossover design: 1. Medium dose / Medium dose / Placebo 2. Medium dose / Placebo / Medium dose 3. Placebo / Medium dose / Medium dose Part II efficacy data utilized for the analysis.	PHA-022121 High Dose - 30 mg n=20 Participants Part II: 2 single high doses of PHA-022121 (30 mg) and one single dose of placebo in a 3-way crossover design: 1. High dose / High dose / Placebo 2. High dose / Placebo / High dose 3. Placebo / High dose / High dose Part II efficacy data utilized for the analysis.	Placebo n=51 Participants Part II: 2 single high doses of PHA-022121 (10, 20, or 30 mg) and one single dose of placebo in a 3-way crossover design: 1. PHA-022121 dose / PHA-022121 dose / Placebo 2. PHA-022121 dose / Placebo / PHA-022121 dose 3. Placebo / PHA-022121 dose / PHA-022121 dose Part II efficacy data utilized for the analysis.
Proportion of Study Drug Treated Attacks Requiring HAE Rescue Medication Within 24 Hours. Number of treated attacks	37 Attacks requiring HAE rescue medication	28 Attacks requiring HAE rescue medication	31 Attacks requiring HAE rescue medication	51 Attacks requiring HAE rescue medication
Proportion of Study Drug Treated Attacks Requiring HAE Rescue Medication Within 24 Hours. Number of treated attacks requiring HAE rescue medication	9 Attacks requiring HAE rescue medication	3 Attacks requiring HAE rescue medication	4 Attacks requiring HAE rescue medication	37 Attacks requiring HAE rescue medication

SECONDARY outcome

Timeframe: Assessed at 48 hours post-study drug treatment

Population: Part I efficacy data not collected, consistent with and pre-specified in the study protocol. Includes all participants with evaluable data who completed the relevant assessment time point.

Qualifying attacks treated with study drug may use approved rescue medication if no symptom relief within 4 hours has been experienced.

Outcome measures

Outcome measures
Measure	PHA-022121 Low Dose - 10 mg n=37 Number of Treated Attacks Part II: 2 single low doses of PHA-022121 (10 mg) and one single dose of placebo in a 3-way crossover design: 1. Low dose / Low dose / Placebo 2. Low dose / Placebo / Low dose 3. Placebo / Low dose / Low dose Part II efficacy data utilized for the analysis.	PHA-022121 Medium Dose - 20 mg n=28 Number of Treated Attacks Part II: 2 single medium doses of PHA-022121 (20 mg) and one single dose of placebo in a 3-way crossover design: 1. Medium dose / Medium dose / Placebo 2. Medium dose / Placebo / Medium dose 3. Placebo / Medium dose / Medium dose Part II efficacy data utilized for the analysis.	PHA-022121 High Dose - 30 mg n=31 Number of Treated Attacks Part II: 2 single high doses of PHA-022121 (30 mg) and one single dose of placebo in a 3-way crossover design: 1. High dose / High dose / Placebo 2. High dose / Placebo / High dose 3. Placebo / High dose / High dose Part II efficacy data utilized for the analysis.	Placebo n=51 Number of Treated Attacks Part II: 2 single high doses of PHA-022121 (10, 20, or 30 mg) and one single dose of placebo in a 3-way crossover design: 1. PHA-022121 dose / PHA-022121 dose / Placebo 2. PHA-022121 dose / Placebo / PHA-022121 dose 3. Placebo / PHA-022121 dose / PHA-022121 dose Part II efficacy data utilized for the analysis.
Proportion of Study Drug Treated Attacks Requiring HAE Rescue Medication Within 48 Hours Number of treated attacks	37 Attacks requiring HAE rescue medication	28 Attacks requiring HAE rescue medication	31 Attacks requiring HAE rescue medication	51 Attacks requiring HAE rescue medication
Proportion of Study Drug Treated Attacks Requiring HAE Rescue Medication Within 48 Hours Number of treated attacks requiring HAE rescue medication	9 Attacks requiring HAE rescue medication	4 Attacks requiring HAE rescue medication	5 Attacks requiring HAE rescue medication	37 Attacks requiring HAE rescue medication

SECONDARY outcome

Timeframe: 48 hours post-treatment

Population: Part I efficacy data not collected, consistent with and pre-specified in the study protocol. Includes all participants with evaluable data who completed the relevant assessment time point.

MMRM analysis of Treatment Satisfaction Questionnaire for Medication (TSQM) at 48 hours post-treatment. The 11-item TSQM (version II) evaluated participant treatment satisfaction with the medication for the following scales: effectiveness, side effects, convenience, and overall satisfaction Scale scores were transformed into scores ranging from 0 to 100 and could be used to calculate a total composite score, a higher score indicating greater satisfaction.

Outcome measures

Outcome measures
Measure	PHA-022121 Low Dose - 10 mg n=21 Participants Part II: 2 single low doses of PHA-022121 (10 mg) and one single dose of placebo in a 3-way crossover design: 1. Low dose / Low dose / Placebo 2. Low dose / Placebo / Low dose 3. Placebo / Low dose / Low dose Part II efficacy data utilized for the analysis.	PHA-022121 Medium Dose - 20 mg n=16 Participants Part II: 2 single medium doses of PHA-022121 (20 mg) and one single dose of placebo in a 3-way crossover design: 1. Medium dose / Medium dose / Placebo 2. Medium dose / Placebo / Medium dose 3. Placebo / Medium dose / Medium dose Part II efficacy data utilized for the analysis.	PHA-022121 High Dose - 30 mg n=20 Participants Part II: 2 single high doses of PHA-022121 (30 mg) and one single dose of placebo in a 3-way crossover design: 1. High dose / High dose / Placebo 2. High dose / Placebo / High dose 3. Placebo / High dose / High dose Part II efficacy data utilized for the analysis.	Placebo n=51 Participants Part II: 2 single high doses of PHA-022121 (10, 20, or 30 mg) and one single dose of placebo in a 3-way crossover design: 1. PHA-022121 dose / PHA-022121 dose / Placebo 2. PHA-022121 dose / Placebo / PHA-022121 dose 3. Placebo / PHA-022121 dose / PHA-022121 dose Part II efficacy data utilized for the analysis.
Treatment Satisfaction Questionnaire for Medication Scores at 48 Hours Post-treatment - Convenience Domain Score	80.56 Score on a scale Standard Deviation 16.569	83.08 Score on a scale Standard Deviation 23.096	77.55 Score on a scale Standard Deviation 20.229	76.07 Score on a scale Standard Deviation 27.441

SECONDARY outcome

Timeframe: 48 hours post-treatment

Population: Part I efficacy data not collected, consistent with and pre-specified in the study protocol. Includes all participants with evaluable data who completed the relevant assessment time point.

MMRM analysis of Treatment Satisfaction Questionnaire for Medication (TSQM) at 48 hours post-treatment. The 11-item TSQM (version II) evaluated participant treatment satisfaction with the medication for the following scales: effectiveness, side effects, convenience, and overall satisfaction Scale scores were transformed into scores ranging from 0 to 100 and could be used to calculate a total composite score, a higher score indicating greater satisfaction.

Outcome measures

Outcome measures
Measure	PHA-022121 Low Dose - 10 mg n=21 Participants Part II: 2 single low doses of PHA-022121 (10 mg) and one single dose of placebo in a 3-way crossover design: 1. Low dose / Low dose / Placebo 2. Low dose / Placebo / Low dose 3. Placebo / Low dose / Low dose Part II efficacy data utilized for the analysis.	PHA-022121 Medium Dose - 20 mg n=16 Participants Part II: 2 single medium doses of PHA-022121 (20 mg) and one single dose of placebo in a 3-way crossover design: 1. Medium dose / Medium dose / Placebo 2. Medium dose / Placebo / Medium dose 3. Placebo / Medium dose / Medium dose Part II efficacy data utilized for the analysis.	PHA-022121 High Dose - 30 mg n=20 Participants Part II: 2 single high doses of PHA-022121 (30 mg) and one single dose of placebo in a 3-way crossover design: 1. High dose / High dose / Placebo 2. High dose / Placebo / High dose 3. Placebo / High dose / High dose Part II efficacy data utilized for the analysis.	Placebo n=51 Participants Part II: 2 single high doses of PHA-022121 (10, 20, or 30 mg) and one single dose of placebo in a 3-way crossover design: 1. PHA-022121 dose / PHA-022121 dose / Placebo 2. PHA-022121 dose / Placebo / PHA-022121 dose 3. Placebo / PHA-022121 dose / PHA-022121 dose Part II efficacy data utilized for the analysis.
Treatment Satisfaction Questionnaire for Medication Scores at 48 Hours Post-treatment - Satisfaction Domain Score	82.50 Score on a scale Standard Deviation 18.907	80.68 Score on a scale Standard Deviation 29.702	76.74 Score on a scale Standard Deviation 22.113	64.10 Score on a scale Standard Deviation 24.623

SECONDARY outcome

Timeframe: Within 48 hours post-treatment

Population: Part I efficacy data not collected, consistent with and pre-specified in the study protocol. Includes all participants with evaluable data who completed the relevant assessment time point.

Time to change in the VAS score for Skin Swelling Score - 30% reduction within 48 hours post-treatment. VAS-3 scores range between 0 and 100. A larger reduction means a better outcome.

Outcome measures

Outcome measures
Measure	PHA-022121 Low Dose - 10 mg n=17 Participants Part II: 2 single low doses of PHA-022121 (10 mg) and one single dose of placebo in a 3-way crossover design: 1. Low dose / Low dose / Placebo 2. Low dose / Placebo / Low dose 3. Placebo / Low dose / Low dose Part II efficacy data utilized for the analysis.	PHA-022121 Medium Dose - 20 mg n=12 Participants Part II: 2 single medium doses of PHA-022121 (20 mg) and one single dose of placebo in a 3-way crossover design: 1. Medium dose / Medium dose / Placebo 2. Medium dose / Placebo / Medium dose 3. Placebo / Medium dose / Medium dose Part II efficacy data utilized for the analysis.	PHA-022121 High Dose - 30 mg n=18 Participants Part II: 2 single high doses of PHA-022121 (30 mg) and one single dose of placebo in a 3-way crossover design: 1. High dose / High dose / Placebo 2. High dose / Placebo / High dose 3. Placebo / High dose / High dose Part II efficacy data utilized for the analysis.	Placebo n=40 Participants Part II: 2 single high doses of PHA-022121 (10, 20, or 30 mg) and one single dose of placebo in a 3-way crossover design: 1. PHA-022121 dose / PHA-022121 dose / Placebo 2. PHA-022121 dose / Placebo / PHA-022121 dose 3. Placebo / PHA-022121 dose / PHA-022121 dose Part II efficacy data utilized for the analysis.
Time to Change in the VAS Score for Skin Swelling Score - 30% Reduction	2.5 Hours Interval 1.4 to 5.8	3.5 Hours Interval 2.2 to 20.0	3.8 Hours Interval 1.9 to 4.8	23.3 Hours Interval 3.9 to Insufficient number of participants with events.

SECONDARY outcome

Timeframe: Within 48 hours post-treatment

Population: Part I efficacy data not collected, consistent with and pre-specified in the study protocol. Includes all participants with evaluable data who completed the relevant assessment time point.

Time to change in the VAS score for Abdominal Pain Score - 30% reduction within 48 hours post-treatment. VAS-3 scores range between 0 and 100. A larger reduction means a better outcome.

Outcome measures

Outcome measures
Measure	PHA-022121 Low Dose - 10 mg n=12 Participants Part II: 2 single low doses of PHA-022121 (10 mg) and one single dose of placebo in a 3-way crossover design: 1. Low dose / Low dose / Placebo 2. Low dose / Placebo / Low dose 3. Placebo / Low dose / Low dose Part II efficacy data utilized for the analysis.	PHA-022121 Medium Dose - 20 mg n=8 Participants Part II: 2 single medium doses of PHA-022121 (20 mg) and one single dose of placebo in a 3-way crossover design: 1. Medium dose / Medium dose / Placebo 2. Medium dose / Placebo / Medium dose 3. Placebo / Medium dose / Medium dose Part II efficacy data utilized for the analysis.	PHA-022121 High Dose - 30 mg n=9 Participants Part II: 2 single high doses of PHA-022121 (30 mg) and one single dose of placebo in a 3-way crossover design: 1. High dose / High dose / Placebo 2. High dose / Placebo / High dose 3. Placebo / High dose / High dose Part II efficacy data utilized for the analysis.	Placebo n=20 Participants Part II: 2 single high doses of PHA-022121 (10, 20, or 30 mg) and one single dose of placebo in a 3-way crossover design: 1. PHA-022121 dose / PHA-022121 dose / Placebo 2. PHA-022121 dose / Placebo / PHA-022121 dose 3. Placebo / PHA-022121 dose / PHA-022121 dose Part II efficacy data utilized for the analysis.
Time to Change in the VAS Score for Abdominal Pain Score - 30% Reduction	1.9 Hours Interval 1.1 to 2.1	1.4 Hours Interval 0.9 to 2.5	2.9 Hours Interval 1.9 to 7.5	20.0 Hours Interval 2.9 to Insufficient number of participants with events.

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Part I PHA-022121 Low Dose - 10 mg n=23 participants at risk Part I: Single low dose of PHA-022121 (10 mg), non-attack state.	Part I PHA-022121 Medium Dose - 20 mg n=24 participants at risk Part I: Single medium dose of PHA-022121 (20 mg), non-attack state.	Part I PHA-022121 High Dose - 30 mg n=25 participants at risk Part I: Single high dose of PHA-022121 (30 mg), non-attack state.	Part II PHA-022121 Low Dose - 10 mg Study Drug Treated Attacks n=38 participants at risk Part II: 2 single low doses of PHA-022121 (10 mg) and one single dose of placebo in a 3-way crossover design: 1. Low dose / Low dose / Placebo 2. Low dose / Placebo / Low dose 3. Placebo / Low dose / Low dose Number at risk reflects number of study drug treated attacks.	Part II PHA-022121 Medium Dose - 20 mg Study Drug Treated Attacks n=29 participants at risk Part II: 2 single medium doses of PHA-022121 (20 mg) and one single dose of placebo in a 3-way crossover design: 1. Medium dose / Medium dose / Placebo 2. Medium dose / Placebo / Medium dose 3. Placebo / Medium dose / Medium dose Number at risk reflects number of study drug treated attacks.	Part II PHA-022121 High Dose - 30 mg Study Drug Treated Attacks n=36 participants at risk Part II: 2 single high doses of PHA-022121 (30 mg) and one single dose of placebo in a 3-way crossover design: 1. High dose / High dose / Placebo 2. High dose / Placebo / High dose 3. Placebo / High dose / High dose Number at risk reflects number of study drug treated attacks.	Part II PHA-022121 Low Dose - 10 mg Participants n=21 participants at risk Part II: 2 single low doses of PHA-022121 (10 mg) and one single dose of placebo in a 3-way crossover design: 1. Low dose / Low dose / Placebo 2. Low dose / Placebo / Low dose 3. Placebo / Low dose / Low dose Number at risk reflects number of participants at risk.	Part II PHA-022121 Medium Dose - 20 mg Participants n=16 participants at risk Part II: 2 single medium doses of PHA-022121 (20 mg) and one single dose of placebo in a 3-way crossover design: 1. Medium dose / Medium dose / Placebo 2. Medium dose / Placebo / Medium dose 3. Placebo / Medium dose / Medium dose Number at risk reflects number of participants at risk.	Part II PHA-022121 High Dose - 30 mg Participants n=22 participants at risk Part II: 2 single high doses of PHA-022121 (30 mg) and one single dose of placebo in a 3-way crossover design: 1. High dose / High dose / Placebo 2. High dose / Placebo / High dose 3. Placebo / High dose / High dose Number at risk reflects number of participants at risk.	Part II Placebo n=53 participants at risk Part II: 2 single high doses of PHA-022121 (10, 20, or 30 mg) and one single dose of placebo in a 3-way crossover design: 1. PHA-022121 dose / PHA-022121 dose / Placebo 2. PHA-022121 dose / Placebo / PHA-022121 dose 3. Placebo / PHA-022121 dose / PHA-022121 dose
Investigations Blood bilirubin increased	0.00% 0/23 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/24 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/25 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/38 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/29 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	2.8% 1/36 • Number of events 1 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/21 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/16 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	4.5% 1/22 • Number of events 1 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/53 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.
Nervous system disorders Headache	0.00% 0/23 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	4.2% 1/24 • Number of events 1 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	8.0% 2/25 • Number of events 2 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/38 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/29 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/36 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/21 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/16 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/22 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/53 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.
General disorders Fatigue	0.00% 0/23 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/24 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/25 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	2.6% 1/38 • Number of events 1 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/29 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	2.8% 1/36 • Number of events 1 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	4.8% 1/21 • Number of events 1 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/16 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	4.5% 1/22 • Number of events 1 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/53 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.
Gastrointestinal disorders Nausea	4.3% 1/23 • Number of events 1 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/24 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/25 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/38 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/29 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	2.8% 1/36 • Number of events 1 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/21 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/16 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	4.5% 1/22 • Number of events 1 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/53 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.
Gastrointestinal disorders Vomiting	0.00% 0/23 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/24 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/25 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/38 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/29 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	2.8% 1/36 • Number of events 1 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/21 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/16 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	4.5% 1/22 • Number of events 1 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/53 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.
Renal and urinary disorders Lower urinary tract symptoms	0.00% 0/23 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/24 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/25 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/38 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	3.4% 1/29 • Number of events 1 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/36 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/21 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	6.2% 1/16 • Number of events 1 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/22 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/53 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.
Infections and infestations Gastrointestinal infection	0.00% 0/23 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/24 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/25 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	2.6% 1/38 • Number of events 1 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/29 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/36 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	4.8% 1/21 • Number of events 1 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/16 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/22 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/53 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.
Infections and infestations Nasopharyngitis	0.00% 0/23 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/24 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	8.0% 2/25 • Number of events 2 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	2.6% 1/38 • Number of events 1 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/29 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/36 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	4.8% 1/21 • Number of events 1 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/16 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/22 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/53 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.
Gastrointestinal disorders Dental caries	0.00% 0/23 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	4.2% 1/24 • Number of events 1 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/25 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/38 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/29 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/36 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/21 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/16 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/22 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/53 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.
Infections and infestations Viral Infection	4.3% 1/23 • Number of events 1 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/24 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/25 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/38 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/29 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/36 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/21 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/16 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/22 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/53 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.
Infections and infestations Sinusitis	0.00% 0/23 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/24 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/25 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/38 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/29 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/36 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/21 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/16 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/22 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	1.9% 1/53 • Number of events 1 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.
Skin and subcutaneous tissue disorders Blister	0.00% 0/23 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/24 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/25 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/38 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/29 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/36 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/21 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/16 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/22 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	1.9% 1/53 • Number of events 1 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.
Investigations Mean cell hemoglobin decreased	0.00% 0/23 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/24 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/25 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/38 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/29 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/36 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/21 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/16 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/22 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	1.9% 1/53 • Number of events 1 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.
Investigations Mean cell volume decreased	0.00% 0/23 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/24 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/25 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/38 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/29 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/36 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/21 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/16 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/22 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	1.9% 1/53 • Number of events 1 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/23 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/24 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	4.0% 1/25 • Number of events 1 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/38 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/29 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/36 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/21 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/16 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/22 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.	0.00% 0/53 • All AEs (including SAEs) recorded from the time of signing informed consent until the end-of-study visit. Timeframe for reporting adverse events: 5 days post-treatment. Adverse events are reported separately for Part I (non-attack) and Part II within the table below, as in Part I, study participants administered a single dose of study drug to assess PK and safety, and in Part II, study participants administered study drug to treat up to 3 qualified HAE attacks. For Part II, total participants at risk and total number of attacks at risk are reported separately. Part II total participants at risk reflect randomized treatment assignments and pooled attacks.

Additional Information

Pharvaris Clinical

Pharvaris Netherlands B.V.

Phone: 31 712036410

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place