Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase 1 bridging study being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ALXN2050 after both single- and multiple-dosing in healthy participants of Japanese descent.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: ALXN2050 (Dose 1) | Experimental | Participants will receive ALXN2050 (Dose 1) as follows under fasting conditions: 120-milligrams (mg) single dose, 3-day washout, then 120-mg twice daily (BID) dosing. |
|
| Cohort 1: Placebo (Dose 1) | Experimental | Participants will receive placebo (Dose 1) as follows under fasting conditions: 120-mg placebo single dose, 3-day washout, then 120-mg placebo BID dosing. |
|
| Cohort 2: ALXN2050 (Dose 2) | Experimental | Participants will receive ALXN2050 (Dose 2) as follows under fasting conditions: 180-mg single dose, 3-day washout, then 180-mg BID dosing. |
|
| Cohort 2: Placebo (Dose 2) | Experimental | Participants will receive placebo (Dose 2) as follows under fasting conditions: 180-mg placebo single dose, 3-day washout, then 180-mg placebo BID dosing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALXN2050 | Drug | Oral tablet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number Of Participants With Treatment-emergent Adverse Events | see Time Frame - defined | Day 1 (after first dose) through follow-up (7 +/- 2 days after final dose) |
| Area Under The Concentration-time Curve From Time Zero To Infinity (AUCinf) For Single-dose ALXN2050 | see Time Frame - defined | Up to 72 hours postdose |
| Maximum Plasma Concentration (Cmax) For Single-dose ALXN2050 | see Time Frame - defined | Up to 72 hours postdose |
| Time To Maximum Plasma Concentration (Tmax) For Single-dose ALXN2050 | see Time Frame - defined | Up to 72 hours postdose |
| Area Under The Concentration-time Curve From Time Zero To The 12-hour Time Point (AUC0-12) For Multiple-dose ALXN2050 | see Time Frame - defined | Up to 72 hours postdose |
| Cmax For Multiple-dose ALXN2050 | see Time Frame - defined | Up to 72 hours postdose |
| Tmax For Multiple-dose ALXN2050 | see Time Frame - defined | Up to 72 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Alternative Pathway Activity As Measured By Wieslab Assay | see Time Frame - defined | Up to 72 hours postdose |
| Complement Factor B Fraction b Levels | see Time Frame - defined |
Not provided
Key Inclusion Criteria:
Medically healthy with no clinically significant or relevant abnormalities as determined by medical history, physical or neurological examination, vital signs, 12-lead electrocardiogram, screening clinical laboratory profiles.
Participants must be of Japanese descent defined as:
Participants must be able to speak, read, and understand the Japanese and English languages.
Body mass index within the range 18.5 to 30.0 kilograms (kg)/meter squared, inclusive, with a minimum body weight of 50.0 kg at Screening.
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Tempe | Arizona | 85283 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020742 | rhoA GTP-Binding Protein |
| ID | Term |
|---|---|
| D020741 | rho GTP-Binding Proteins |
| D020559 | Monomeric GTP-Binding Proteins |
| D019204 | GTP-Binding Proteins |
| D020558 | GTP Phosphohydrolases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Oral tablet. |
|
| Up to 72 hours postdose |
| D017766 | Acid Anhydride Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D002352 | Carrier Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D047908 | Intracellular Signaling Peptides and Proteins |