| Primary | Number of Participants With Serious Adverse Events (SAE) and Treatment-Emergent Adverse Events (TEAE) | A SAE was any adverse experience occurring at any dose that resulted in any of the following outcomes: Death, Life-threatening experience, required inpatient hospitalization or prolongation of existing hospitalization. Resulted in persistent or significant disability or incapacity. Was a congenital anomaly or birth defect. Was considered to be an important medical event. An AE was considered treatment-emergent if the onset time was after administration of study drug through the Day 120 post-dose final follow-up visit or, in the event that onset time preceded study drug administration, the AE increased in severity during the 120-day post-dose follow-up period. | Safety Population included all randomized participants who received at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | From Day 1 up to final follow-up (Day 123) | | | | ID | Title | Description |
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| OG000 | DX-2930, Cohort 1 | Participants received 30 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. | | OG001 | DX-2930, Cohort 2 | Participants received 100 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. | | OG002 | DX-2930, Cohort 3 | Participants received 300 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. | | OG003 | DX-2930, Cohort 4 | Participants received 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. | | OG004 | Placebo | Participants received placebo matched to 30, 100, 300 and 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. |
| | | Title | Denominators | Categories |
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| Serious Adverse Events | | |
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| Secondary | Maximum Plasma Concentration (Cmax) | Pharmacokinetic (PK) parameter Cmax data were reported. | Pharmacokinectic (PK) population included all randomized HAE participants in the safety population who had sufficient blood samples to obtain a plasma concentration versus time profile. | Posted | | Mean | Standard Deviation | Nanogram per milliliter (ng/mL) | | Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120 | | | | ID | Title | Description |
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| OG000 | DX-2930, Cohort 1 | Participants received 30 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. | | OG001 | DX-2930, Cohort 2 | Participants received 100 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. | | OG002 | DX-2930, Cohort 3 | Participants received 300 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. | | OG003 | DX-2930, Cohort 4 | |
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| Secondary | Time to Maximum Plasma Concentration (Tmax) | PK parameter Tmax data were reported. | Pharmacokinectic (PK) population included all randomized HAE participants in the safety population who had sufficient blood samples to obtain a plasma concentration versus time profile. | Posted | | Mean | Standard Deviation | Days | | Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120 | | | | ID | Title | Description |
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| OG000 | DX-2930, Cohort 1 | Participants received 30 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. | | OG001 | DX-2930, Cohort 2 | Participants received 100 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. | | OG002 | DX-2930, Cohort 3 | Participants received 300 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. | | OG003 | DX-2930, Cohort 4 | Participants received 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. |
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| Secondary | Area Under the Plasma Concentration-Time Curve (AUC) | PK paramenter AUC data were reported. | Pharmacokinectic (PK) population included all randomized HAE participants in the safety population who had sufficient blood samples to obtain a plasma concentration versus time profile. | Posted | | Mean | Standard Deviation | day*nanogram per milliliter (day*ng/mL) | | Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120 | | | | ID | Title | Description |
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| OG000 | DX-2930, Cohort 1 | Participants received 30 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. | | OG001 | DX-2930, Cohort 2 | Participants received 100 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. | | OG002 | DX-2930, Cohort 3 | Participants received 300 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. | | OG003 | DX-2930, Cohort 4 | |
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| Secondary | Apparent Clearance (CL/F) | PK parameter CL/F data were reported. | Pharmacokinectic (PK) population included all randomized HAE participants in the safety population who had sufficient blood samples to obtain a plasma concentration versus time profile. | Posted | | Mean | Standard Deviation | Liter per day (L/day) | | Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120 | | | | ID | Title | Description |
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| OG000 | DX-2930, Cohort 1 | Participants received 30 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. | | OG001 | DX-2930, Cohort 2 | Participants received 100 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. | | OG002 | DX-2930, Cohort 3 | Participants received 300 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. | | OG003 | DX-2930, Cohort 4 | Participants received 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. |
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| Secondary | Apparent Volume of Distribution (Vd/F) | PK parameter Vd/F data were reported. | Pharmacokinectic (PK) population included all randomized HAE participants in the safety population who had sufficient blood samples to obtain a plasma concentration versus time profile. | Posted | | Mean | Standard Deviation | Liter (L) | | Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120 | | | | ID | Title | Description |
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| OG000 | DX-2930, Cohort 1 | Participants received 30 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. | | OG001 | DX-2930, Cohort 2 | Participants received 100 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. | | OG002 | DX-2930, Cohort 3 | Participants received 300 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. | | OG003 | DX-2930, Cohort 4 | Participants received 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. |
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| Secondary | Terminal Elimination Half-Life (t1/2) | PK parameter t(1/2) data were reported. | Pharmacokinectic (PK) population included all randomized HAE participants in the safety population who had sufficient blood samples to obtain a plasma concentration versus time profile. | Posted | | Mean | Standard Deviation | Day | | Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120 | | | | ID | Title | Description |
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| OG000 | DX-2930, Cohort 1 | Participants received 30 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. | | OG001 | DX-2930, Cohort 2 | Participants received 100 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. | | OG002 | DX-2930, Cohort 3 | Participants received 300 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. | | OG003 | DX-2930, Cohort 4 | Participants received 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. |
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| Other Pre-specified | HAE Attack Rate Per Week From Day 8 to Day 50 | Analysis of this outcome measure was based on participants in the 300 mg, 400 mg, and placebo dose groups with a historical baseline attack rate of at least 2 attacks over the last 3 months prior to enrollment. The result is based on General Estimating Equation (GEE) analysis of repeated counts per week during the pre-specified assessment period (Days 8 to 50; predicted to correspond to a period of notable drug exposure). Baseline HAE attack rate per week was a covariate, treatment group is a fixed effect, and participant was a random effect in the GEE model with independence working correlation structure. | All randomized participants in the 300 mg, 400 mg, and placebo groups who received at least 1 dose of study drug and who had a historical baseline attack rate of at least 2 attacks in the 3 months prior to enrollment. | Posted | | Mean | Standard Error | HAE attacks per week | | Day 8 to Day 50 | | | | ID | Title | Description |
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| OG000 | DX-2930, Cohort 3 | Participants received 300 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. | | OG001 | DX-2930, Cohort 4 | Participants received 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. | | OG002 |
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| Other Pre-specified | HAE Attacks Per Week From Day 8 to Day 92 | This endpoint analysis was based on participants in the 300 mg, 400 mg, and placebo dose groups with a historical baseline attack rate of at least 2 attacks over the last 3 months prior to enrollment. The result is based on General Estimating Equation (GEE) analysis of repeated counts per week during the prespecified assessment period (Day 8 to Day 92 predicted to correspond to a period of notable drug exposure). Baseline HAE attack rate per week is a covariate, treatment group is a fixed effect, and participant is a random effect in the GEE model with independence working correlation structure. | All randomized participants in the 300 mg, 400 mg, and placebo groups who received at least 1 dose of study drug and who had a historical baseline attack rate of at least 2 attacks in the 3 months prior to enrollment. | Posted | | Mean | Standard Deviation | HAE Attacks per Week | | Day 8 to Day 92 | | | | ID | Title | Description |
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| OG000 | DX-2930, Cohort 3 | Participants received 300 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. | | OG001 | DX-2930, Cohort 4 | Participants received 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. | | OG002 |
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| Other Pre-specified | HAE Attacks Per Week From Day 8 to Day 64 | This endpoint analysis was based on participants in the 300 mg, 400 mg, and placebo dose groups with a historical baseline attack rate of at least 2 attacks over the last 3 months prior to enrollment. The result is based on General Estimating Equation (GEE) analysis of repeated counts per week during the prespecified assessment period (Day 8 to Day 64 predicted to correspond to a period of notable drug exposure). Baseline HAE attack rate per week is a covariate, treatment group is a fixed effect, and participant is a random effect in the GEE model with independence working correlation structure. | All randomized participants in the 300 mg, 400 mg, and placebo groups who received at least 1 dose of study drug and who had a historical baseline attack rate of at least 2 attacks in the 3 months prior to enrollment. | Posted | | Mean | Standard Deviation | HAE Attacks per Week | | Day 8 to Day 64 | | | | ID | Title | Description |
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| OG000 | DX-2930, Cohort 3 | Participants received 300 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. | | OG001 | DX-2930, Cohort 4 | Participants received 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. | | OG002 |
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| Other Pre-specified | HAE Attack Rate Per Week From Day 1 to Day 50 | This endpoint analysis was based on participants in the 300 mg, 400 mg, and placebo dose groups with a historical baseline attack rate of at least 2 attacks over the last 3 months prior to enrollment. The result is based on General Estimating Equation (GEE) analysis of repeated counts per week during the prespecified assessment period (Day 1 to Day 50 predicted to correspond to a period of notable drug exposure). Baseline HAE attack rate per week is a covariate, treatment group is a fixed effect, and participant is a random effect in the GEE model with independence working correlation structure. | All randomized participants in the 300 mg, 400 mg, and placebo groups who received at least 1 dose of study drug and who had a historical baseline attack rate of at least 2 attacks in the 3 months prior to enrollment. | Posted | | Mean | Standard Deviation | HAE attacks per week | | Day 1 to Day 50 | | | | ID | Title | Description |
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| OG000 | DX-2930, Cohort 3 | Participants received 300 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. | | OG001 | DX-2930, Cohort 4 | Participants received 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. | | OG002 |
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