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This is a Phase 1, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of single ascending doses (SADs) of ALXN1910 subcutaneous (SC) and SAD of ALXN1910 intravenous (IV).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Participants will receive a single dose of 5 mg of ALXN1910 IV or Placebo IV. |
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| Cohort 2 | Experimental | Participants will receive a single dose of 15 mg of ALXN1910 SC or Placebo SC. |
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| Cohort 3 | Experimental | Participant will receive a single dose of 15 mg of ALXN1910 IV or Placebo IV. |
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| Cohort 4 | Experimental | Japanese participants will receive a single dose of 15 mg of ALXN1910 SC or Placebo SC. |
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| Cohort 5 | Experimental | Participants will receive a single dose of 45 mg of ALXN1910 SC or Placebo SC. |
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| Cohort 6 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALXN1910 | Drug | Participants will receive a single dose of ALXN1910 IV or ALXN1910 SC according to their assigned cohort. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | The safety and tolerability of ALXN1910 was assessed. | Day 1 (postdose) through Day 75 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) | The Cmax was assessed as PK parameter of single ascending doses of ALXN1910. | Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75 |
| Time to Maximum Observed Serum Concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Harrow | HA1 3UJ | United Kingdom |
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| Label | URL |
|---|---|
| Related Info | View source |
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The screening period was up to 28 days. Informed consent form (ICF) was signed prior to screening procedures. Subjects received study drug in a randomised order. All the study assessments were performed as per the schedule of assessment.
Subjects who met all the inclusion and none of the exclusion criteria were randomized in 1 site. The study was conducted from 12 Apr 2022 to 07 Feb 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1- 5 mg | Participants received a single dose of 5 mg of ALXN1910 IV. |
| FG001 | Cohort 2- 15 mg SC | Participants received a single dose of 15 mg of ALXN1910 SC. |
| FG002 | Cohort 3- 15 mg IV | Participant received a single dose of 15 mg of ALXN1910 IV. |
| FG003 | Japanese Cohort 4- 15 mg SC | Japanese participants received a single dose of 15 mg of ALXN1910 SC. |
| FG004 | Cohort 5- 45 mg | Participants received a single dose of 45 mg of ALXN1910 SC. |
| FG005 | Cohort 6- 135 mg | Participants received a single dose of 135 mg of ALXN1910 SC. |
| FG006 | Pooled Placebo | Participants received a single dose of matching Placebo IV or SC. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All participants who receive any amount of study intervention were included in the Safety Set. Participants were analyzed according to the study intervention received.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1- 5 mg | Participants received a single dose of 5 mg of ALXN1910 IV. |
| BG001 | Cohort 2- 15 mg SC | Participants received a single dose of 15 mg of ALXN1910 SC. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | The safety and tolerability of ALXN1910 was assessed. | All participants who received any amount of study intervention were included in the Safety Analysis Set. Participants were analyzed according to the study intervention received. | Posted | Count of Participants | Participants | Day 1 (postdose) through Day 75 |
|
Day 1 (postdose) through Day 75
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1- 5 mg | Participants received a single dose of 5 mg of ALXN1910 IV. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Loss of consciousness | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Catheter site bruise | General disorders | MedDRA Version 25.1 | Non-systematic Assessment |
For Outcome measure #12 Plasma Concentration of Inorganic Pyrophosphate (PPi); #13 Plasma Concentration of Pyridoxal (PL); #14 Plasma Concentration of Pyridoxal 5-Phosphate (PLP); 15 Plasma Concentration of Pyridoxic Acid (PA); Cohort 4 Day 75 standard deviation is provided for the posting although standard deviation will not be calculated for less than 3 data points per study's Statistical Analysis Plan.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexion Pharmaceuticals, Inc. | Alexion Pharmaceuticals, Inc. | +1 855-752-2356 | clinicaltrials@alexion.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 27, 2022 | Jan 31, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 28, 2023 | Feb 7, 2025 | SAP_001.pdf |
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Participants will receive a single dose of 135 mg of ALXN1910 SC or Placebo SC. |
|
| Placebo | Drug | Participants will receive Placebo IV or Placebo SC according to their assigned cohort. |
|
The Tmax was assed as PK parameter of single ascending doses of ALXN1910. |
| Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75 |
| Apparent Terminal Elimination Half Life (t1/2) | The t1/2 was assed as PK parameter of single ascending doses of ALXN1910. | Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75 |
| Terminal-phase Elimination Rate Constant (λz) | The λz was assed as PK parameter of single ascending doses of ALXN1910. | Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75 |
| AUC From Time Zero to the Last Quantifiable Concentratio (AUCt) | The AUCt was assed as PK parameter of single ascending doses of ALXN1910. | Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75 |
| AUC From Time Zero Extrapolated to Infinity (AUC∞) | The AUC∞ was assed as PK parameter of single ascending doses of ALXN1910. | Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75 |
| AUC From Time Zero to 168h (AUC0-168) | The AUC0-168 was assed as PK parameter of single ascending doses of ALXN1910. | Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75 |
| Percentage of AUC∞ Obtained by Extrapolation Beyond Tlast (%AUCex) | The %AUCex was assed as PK parameter of single ascending doses of ALXN1910. | Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75 |
| Total Body Clearance (for IV Cohorts) or Apparent Clearance (for SC Cohorts) (CL or CL/F) | The CL or CL/F was assed as PK parameter of single ascending doses of ALXN1910. | Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75 |
| Volume of Distribution (for IV Cohorts) or Apparent Volume of Distribution (for SC Cohorts) (Vd or Vd/F) | The Vd or Vd/F was assed as PK parameter of single ascending doses of ALXN1910. | Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75 |
| Plasma Concentration of Inorganic Pyrophosphate (PPi) | The plasma concentrations of PPi was assesed. | Day 1 (predose), 2, 3, 5, 8, 15, 22, 29, 36, 43, and 75 |
| Plasma Concentration of Pyridoxal (PL) | The plasma concentrations of PL was assessed. | Day 1 (predose), 2, 3, 5, 8, 15, 22, 29, 36, 43, and 75 |
| Plasma Concentration of Pyridoxal 5-Phosphate (PLP) | The plasma concentrations of PLP was assessed. | Day 1 (predose), 2, 3, 5, 8, 15, 22, 29, 36, 43, and 75 |
| Plasma Concentration of Pyridoxic Acid (PA) | The plasma concentrations of PA was assessed. | Day 1 (predose), 2, 3, 5, 8, 15, 22, 29, 36, 43, and 75 |
| Number of Participants With Positive Treatment-Emergent Antidrug Antibodies (ADAs) | The ADAs of ALXN1910 was assessed as immunogenicity parameter. Treatment-emergent ADA Responses is defined as a positive result in the ADA assay post first dose, when baseline results are negative or missing. | Day 1 (postdose) through Day 75 |
| Geometric Mean Ratio (GMR) of Area Under the Curve (AUC∞) Values of Subcutaneous (SC) Versus Intravenous (IV) Serum Concentration of ALXN1910 | The absolute bioavailability GMR AUC∞ of ALXN1910 SC was assessed. | Up to Day 75 |
| Maximum Observed Serum Concentration (Cmax) in Japanese and Non-Japanese Participants | Quantitative assessment of PK parameter (Cmax) was assessed between Japanese and non-Japanese participants. | Up to Day 75 |
| AUC From Time Zero to the Last Quantifiable Concentration (AUCt) in Japanese and Non-Japanese Participants | Quantitative assessment of PK parameter (AUCt) was assessed between Japanese and non-Japanese participants. | Up to Day 75 |
| AUC From Time Zero Extrapolated to Infinity (AUC∞) in Japanese and Non-Japanese Participants | Quantitative assessment of PK parameter (AUC∞) was assessed between Japanese and non-Japanese participants. | Up to Day 75 |
| Change From Baseline in Inorganic Pyrophosphate Concentration in Japanese and Non-Japanese Participants | Change from baseline in PD parameter Inorganic Pyrophosphate was evaluated over time for Japanese and non-Japanese participants (Cohort 2 versus Cohort 4) on active treatment. | Day 2, 15, 22, 43, and 75 |
| Change From Baseline in Pyridoxal-5-phosphate Concentration in Japanese and Non-Japanese Participants | Change from baseline in PD parameter Pyridoxal-5-phosphate was evaluated over time for Japanese and non-Japanese participants (Cohort 2 versus Cohort 4) on active treatment | Day 2, 15, 22, 43, and 75 |
| Change From Baseline in Pyridoxal Concentration in Japanese and Non-Japanese Participants | Change from baseline in PD parameter Pyridoxal was evaluated over time for Japanese and non-Japanese participants (Cohort 2 versus Cohort 4) on active treatment. | Day 2, 15, 22, 43, and 75 |
| Change From Baseline in Pyridoxic Acid Concentration in Japanese and Non-Japanese Participants | Change from baseline in PD parameter Pyridoxic Acid was evaluated over time for Japanese and non-Japanese participants (Cohort 2 versus Cohort 4) on active treatment. | Day 2, 15, 22, 43, and 75 |
| BG002 | Cohort 3- 15 mg IV | Participant received a single dose of 15 mg of ALXN1910 IV. |
| BG003 | Japanese Cohort 4- 15 mg SC | Japanese participants received a single dose of 15 mg of ALXN1910 SC. |
| BG004 | Cohort 5- 45 mg | Participants received a single dose of 45 mg of ALXN1910 SC. |
| BG005 | Cohort 6- 135 mg | Participants received a single dose of 135 mg of ALXN1910 SC. |
| BG006 | Pooled Placebo | Participants received a single dose of matching Placebo IV or SC. |
| BG007 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | Cohort 3- 15 mg IV | Participant received a single dose of 15 mg of ALXN1910 IV. |
| OG003 | Japanese Cohort 4- 15 mg SC | Japanese participants received a single dose of 15 mg of ALXN1910 SC. |
| OG004 | Cohort 5- 45 mg | Participants received a single dose of 45 mg of ALXN1910 SC. |
| OG005 | Cohort 6- 135 mg | Participants received a single dose of 135 mg of ALXN1910 SC. |
| OG006 | Pooled Placebo | Participants received a single dose of matching Placebo IV or SC. |
|
|
| Secondary | Maximum Observed Serum Concentration (Cmax) | The Cmax was assessed as PK parameter of single ascending doses of ALXN1910. | All treated participants for whom the PK profile of ALXN1910 can be adequately characterized were included in the PK Set. PK analyses were based upon the study intervention received | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram/milliliter (μg/mL) | Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75 |
|
|
|
| Secondary | Time to Maximum Observed Serum Concentration (Tmax) | The Tmax was assed as PK parameter of single ascending doses of ALXN1910. | All treated participants for whom the PK profile of ALXN1910 can be adequately characterized were included in the PK Set. PK analyses were based upon the study intervention received | Posted | Median | Full Range | hour (h) | Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75 |
|
|
|
| Secondary | Apparent Terminal Elimination Half Life (t1/2) | The t1/2 was assed as PK parameter of single ascending doses of ALXN1910. | All treated participants for whom the PK profile of ALXN1910 can be adequately characterized were included in the PK Set. PK analyses were based upon the study intervention received. Here, Number of Participants Analyzed refers to the number of participants available for the specific Outcome measure for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour (h) | Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75 |
|
|
|
| Secondary | Terminal-phase Elimination Rate Constant (λz) | The λz was assed as PK parameter of single ascending doses of ALXN1910. | All treated participants for whom the PK profile of ALXN1910 can be adequately characterized were included in the PK Set. PK analyses were based upon the study intervention received. Here, Number of Participants Analyzed refers to the number of participants available for the specific Outcome measure for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | 1/hour (1/h) | Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75 |
|
|
|
| Secondary | AUC From Time Zero to the Last Quantifiable Concentratio (AUCt) | The AUCt was assed as PK parameter of single ascending doses of ALXN1910. | All treated participants for whom the PK profile of ALXN1910 can be adequately characterized were included in the PK Set. PK analyses were based upon the study intervention received. Here, Number of Participants Analyzed refers to the number of participants available for the specific Outcome measure for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*microgram/milliliter (h*μg/mL) | Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75 |
|
|
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| Secondary | AUC From Time Zero Extrapolated to Infinity (AUC∞) | The AUC∞ was assed as PK parameter of single ascending doses of ALXN1910. | All treated participants for whom the PK profile of ALXN1910 can be adequately characterized were included in the PK Set. PK analyses were based upon the study intervention received. Here, Number of Participants Analyzed refers to the number of participants available for the specific Outcome measure for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*microgram/milliliter (h*μg/mL) | Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75 |
|
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| Secondary | AUC From Time Zero to 168h (AUC0-168) | The AUC0-168 was assed as PK parameter of single ascending doses of ALXN1910. | All treated participants for whom the PK profile of ALXN1910 can be adequately characterized were included in the PK Set. PK analyses were based upon the study intervention received. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*microgram/milliliter (h*μg/mL) | Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75 |
|
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| Secondary | Percentage of AUC∞ Obtained by Extrapolation Beyond Tlast (%AUCex) | The %AUCex was assed as PK parameter of single ascending doses of ALXN1910. | All treated participants for whom the PK profile of ALXN1910 can be adequately characterized were included in the PK Set. PK analyses were based upon the study intervention received. Here, Number of Participants Analyzed refers to the number of participants available for the specific Outcome measure for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage (%) of AUC∞ | Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75 |
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| Secondary | Total Body Clearance (for IV Cohorts) or Apparent Clearance (for SC Cohorts) (CL or CL/F) | The CL or CL/F was assed as PK parameter of single ascending doses of ALXN1910. | All treated participants for whom the PK profile of ALXN1910 can be adequately characterized were included in the PK Set. PK analyses were based upon the study intervention received. Here, Number of Participants Analyzed refers to the number of participants available for the specific Outcome measure for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter/hour (L/h) | Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75 |
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| Secondary | Volume of Distribution (for IV Cohorts) or Apparent Volume of Distribution (for SC Cohorts) (Vd or Vd/F) | The Vd or Vd/F was assed as PK parameter of single ascending doses of ALXN1910. | All treated participants for whom the PK profile of ALXN1910 can be adequately characterized were included in the PK Set. PK analyses were based upon the study intervention received. Here, Number of Participants Analyzed refers to the number of participants available for the specific Outcome measure for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter (L) | Days 1 through 5 (predose and up to 96 hours postdose), postdose on Days 6, 7, 8, 15, 22, 29, 36, 43, and 75 |
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| Secondary | Plasma Concentration of Inorganic Pyrophosphate (PPi) | The plasma concentrations of PPi was assesed. | All treated participants for whom the PD profile of ALXN1910 can be adequately characterized were included in the PD Set. Here, Number Analyzed refers to the number of participants available for the specific Outcome measure for specific timeframe. | Posted | Mean | Standard Deviation | micromole/Liter (umol/L) | Day 1 (predose), 2, 3, 5, 8, 15, 22, 29, 36, 43, and 75 |
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| Secondary | Plasma Concentration of Pyridoxal (PL) | The plasma concentrations of PL was assessed. | All treated participants for whom the PD profile of ALXN1910 can be adequately characterized were included in the PD Set. Here, Number Analyzed refers to the number of participants available for the specific Outcome measure for specific timeframe. | Posted | Mean | Standard Deviation | nanogram/milliliter (ng/ml) | Day 1 (predose), 2, 3, 5, 8, 15, 22, 29, 36, 43, and 75 |
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| Secondary | Plasma Concentration of Pyridoxal 5-Phosphate (PLP) | The plasma concentrations of PLP was assessed. | All treated participants for whom the PD profile of ALXN1910 can be adequately characterized were included in the PD Set. Here, Number Analyzed refers to the number of participants available for the specific Outcome measure for specific timeframe. | Posted | Mean | Standard Deviation | nanogram/milliliter (ng/ml) | Day 1 (predose), 2, 3, 5, 8, 15, 22, 29, 36, 43, and 75 |
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| Secondary | Plasma Concentration of Pyridoxic Acid (PA) | The plasma concentrations of PA was assessed. | All treated participants for whom the PD profile of ALXN1910 can be adequately characterized were included in the PD Set. Here, Number Analyzed refers to the number of participants available for the specific Outcome measure for specific timeframe. | Posted | Mean | Standard Deviation | nanogram/milliliter (ng/ml) | Day 1 (predose), 2, 3, 5, 8, 15, 22, 29, 36, 43, and 75 |
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| Secondary | Number of Participants With Positive Treatment-Emergent Antidrug Antibodies (ADAs) | The ADAs of ALXN1910 was assessed as immunogenicity parameter. Treatment-emergent ADA Responses is defined as a positive result in the ADA assay post first dose, when baseline results are negative or missing. | All randomized/enrolled participants who received at least 1 dose of the study intervention and who after the dose have at least 1 reportable ADA result. Participants were analyzed according to the study intervention they actually received. | Posted | Count of Participants | Participants | Day 1 (postdose) through Day 75 |
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| Secondary | Geometric Mean Ratio (GMR) of Area Under the Curve (AUC∞) Values of Subcutaneous (SC) Versus Intravenous (IV) Serum Concentration of ALXN1910 | The absolute bioavailability GMR AUC∞ of ALXN1910 SC was assessed. | All treated participants for whom the PK profile of ALXN1910 can be adequately characterized were included in the PK Set. PK analyses were based upon the study intervention received. Here, Number Analyzed refers to the number of participants available for the specific Outcome measure analysis. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | h × μg/mL | Up to Day 75 |
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| Secondary | Maximum Observed Serum Concentration (Cmax) in Japanese and Non-Japanese Participants | Quantitative assessment of PK parameter (Cmax) was assessed between Japanese and non-Japanese participants. | All treated participants for whom the PK profile of ALXN1910 can be adequately characterized were included in the PK Set. PK analyses were based upon the study intervention received. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | μg/mL | Up to Day 75 |
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| Secondary | AUC From Time Zero to the Last Quantifiable Concentration (AUCt) in Japanese and Non-Japanese Participants | Quantitative assessment of PK parameter (AUCt) was assessed between Japanese and non-Japanese participants. | All treated participants for whom the PK profile of ALXN1910 can be adequately characterized were included in the PK Set. PK analyses were based upon the study intervention received. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | h × μg/mL | Up to Day 75 |
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| Secondary | AUC From Time Zero Extrapolated to Infinity (AUC∞) in Japanese and Non-Japanese Participants | Quantitative assessment of PK parameter (AUC∞) was assessed between Japanese and non-Japanese participants. | All treated participants for whom the PK profile of ALXN1910 can be adequately characterized were included in the PK Set. PK analyses were based upon the study intervention received. Here, Number Analyzed refers to the number of participants available for the specific Outcome measure analysis. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | h × μg/mL | Up to Day 75 |
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| Secondary | Change From Baseline in Inorganic Pyrophosphate Concentration in Japanese and Non-Japanese Participants | Change from baseline in PD parameter Inorganic Pyrophosphate was evaluated over time for Japanese and non-Japanese participants (Cohort 2 versus Cohort 4) on active treatment. | All treated participants for whom the PD profile of ALXN1910 can be adequately characterized were included in the PD Set. | Posted | Least Squares Mean | Standard Error | μmol | Day 2, 15, 22, 43, and 75 |
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| Secondary | Change From Baseline in Pyridoxal-5-phosphate Concentration in Japanese and Non-Japanese Participants | Change from baseline in PD parameter Pyridoxal-5-phosphate was evaluated over time for Japanese and non-Japanese participants (Cohort 2 versus Cohort 4) on active treatment | All treated participants for whom the PD profile of ALXN1910 can be adequately characterized were included in the PD Set. | Posted | Least Squares Mean | Standard Error | μmol | Day 2, 15, 22, 43, and 75 |
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| Secondary | Change From Baseline in Pyridoxal Concentration in Japanese and Non-Japanese Participants | Change from baseline in PD parameter Pyridoxal was evaluated over time for Japanese and non-Japanese participants (Cohort 2 versus Cohort 4) on active treatment. | All treated participants for whom the PD profile of ALXN1910 can be adequately characterized were included in the PD Set. | Posted | Least Squares Mean | Standard Error | ng/mL | Day 2, 15, 22, 43, and 75 |
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| Secondary | Change From Baseline in Pyridoxic Acid Concentration in Japanese and Non-Japanese Participants | Change from baseline in PD parameter Pyridoxic Acid was evaluated over time for Japanese and non-Japanese participants (Cohort 2 versus Cohort 4) on active treatment. | All treated participants for whom the PD profile of ALXN1910 can be adequately characterized were included in the PD Set. | Posted | Least Squares Mean | Standard Error | ng/mL | Day 2, 15, 22, 43, and 75 |
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| 6 |
| 0 |
| 6 |
| 3 |
| 6 |
| EG001 | Cohort 2- 15 mg SC | Participants received a single dose of 15 mg of ALXN1910 SC. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG002 | Cohort 3- 15 mg IV | Participant received a single dose of 15 mg of ALXN1910 IV. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG003 | Japanese Cohort 4- 15 mg SC | Japanese participants received a single dose of 15 mg of ALXN1910 SC. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG004 | Cohort 5- 45 mg | Participants received a single dose of 45 mg of ALXN1910 SC. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG005 | Cohort 6- 135 mg | Participants received a single dose of 135 mg of ALXN1910 SC. | 0 | 6 | 1 | 6 | 4 | 6 |
| EG006 | Pooled Placebo | Participants received a single dose of matching Placebo IV or SC. | 0 | 12 | 0 | 12 | 8 | 12 |
| Fatigue | General disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Influenza like illness | General disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Catheter site related reaction | General disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Injection site erythema | General disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Coronavirus infection | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Infected bite | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Dizziness postural | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Dental discomfort | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Food poisoning | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Lip dry | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Joint noise | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA Version 25.1 | Non-systematic Assessment |
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| C-reactive protein increased | Investigations | MedDRA Version 25.1 | Non-systematic Assessment |
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| Abnormal dreams | Psychiatric disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Lymphadenitis | Blood and lymphatic system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Allergy to arthropod bite | Immune system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
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| Dysuria | Reproductive system and breast disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Urethral discharge | Renal and urinary disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Dysmenorrhoea | Renal and urinary disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Heavy menstrual bleeding | Reproductive system and breast disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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Not provided
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