Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ALXN1210 · 5 trials · 2 indications
An adverse event (AE) was defined as any unfavorable and unintended sign (for example, including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or procedure, whether or not considered related to the medicinal product or procedure, which occurred during the course of the clinical study. TEAEs were defined as AEs with a start date or time on or after the first dose of the study drug. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
The absolute bioavailability of ALXN1210 SC is reported as the area under the serum concentration versus time curve from time 0 extrapolated to infinity (AUCinf) geometric mean of the ALXN1210 SC group divided by the AUCinf geometric mean of the ALXN1210 IV group\*100. Linear mixed model with fixed and random effects for the participant was used.
An adverse event (AE) was defined as any unfavorable and unintended sign (for example, including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or procedure, whether or not considered related to the medicinal product or procedure, which occurred during the course of the clinical study. TEAEs were defined as AEs that occurred on or after the date and time of study drug administration, or those that first occurred before dosing but worsened in frequency or severity after study drug administration. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Baseline was defined as the average of all available assessments prior to first ALXN1210 infusion.
| Arm | Type | Description |
|---|---|---|
| ALXN1210 SC | EXPERIMENTAL | Participants received ALXN1210 SC. |
| ALXN1210 IV | EXPERIMENTAL | Participants received ALXN1210 IV. |
| Placebo SC | PLACEBO_COMPARATOR | Participants received placebo SC. |
| Cohort 1: ALXN1210 400 mg (Single) | EXPERIMENTAL | A single dose of ALXN1210 was administered intravenously. |
| Cohort 2: ALXN1210 800 mg (Single) | EXPERIMENTAL | A single dose of ALXN1210 was administered intravenously. |
| Cohort 3: ALXN1210 800 mg (Multiple) | EXPERIMENTAL | ALXN1210 (800 mg) was administered intravenously every 4 weeks for a total of 5 doses. |
| Cohort 1 | EXPERIMENTAL | Participants were administered ALXN1210 900 mg. In the Extension period participants continued at the same dose and frequency as the Primary Evaluation Period. |
| Cohort 2 | EXPERIMENTAL | Participants were administered ALXN1210 1800 mg. In the Extension period participants continued at the same dose and frequency as the Primary Evaluation Period. |
| ALXN1210 400 mg | EXPERIMENTAL | Participants received ALXN1210 every 28 days. |
| ALXN1210: 800 mg | EXPERIMENTAL | Participants received ALXN1210 every 28 days. |
| Placebo | PLACEBO_COMPARATOR | Participants received placebo every 28 days. |
| ALXN1210 200 mg | EXPERIMENTAL | ALXN1210 was administered intravenously. |
| Name | Type | Description |
|---|---|---|
| ALXN1210 SC | DRUG | All doses of ALXN1210 SC were administered by four 100-milligram (mg) SC injections of 1 milliliter (mL) each in the abdominal area. All four 1-mL injections were administered over a 15-minute period with at least 15 minutes between the end of injection in 1 participant and the start of injection in the next participant. |
| ALXN1210 IV | DRUG | All doses of ALXN1210 IV were administered by IV infusion, using IV sets with in-line filters, at a maximum rate of 333 mL/hour, excluding interruption for safety or technical reason. There were at least 15 minutes between the end-of-infusion/injection in 1 participant and the start-of infusion/injection in the next participant. |
| Placebo | DRUG | All doses of placebo SC were administered by four 100-mg SC injections of 1 mL each in the abdominal area. All four 1-mL injections were administered over a 15-minute period with at least 15 minutes between the end of injection in 1 participant and the start of injection in the next participant. |
| ALXN1210 | DRUG | Participants received a single dose (400 mg or 800 mg) and multiple doses (800 mg) of ALXN1210. |
Inclusion Criteria: * Body mass index from 18 through 29.9 kilogram (kg)/square meter, inclusive, and weight between 50 and 100 kg, inclusive. * QT interval corrected using Fridericia's formula ≤ 450 milliseconds (msec) for males and ≤ 470 msec for females at Screening and prior to dosing on Day 1....
ALXN1210 is an investigational small molecule being studied for use in paroxysmal nocturnal hemoglobinuria (PNH) and in healthy volunteers. It is currently in Phase 1 clinical development and has not been approved by the FDA.
ALXN1210 is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting Phase 1 clinical trials to evaluate the drug's safety and tolerability.
ALXN1210 is in Phase 1 clinical development. All four completed trials for the drug are Phase 1 studies, and the drug remains investigational, meaning it is not yet approved for any use.
ALXN1210 has completed four Phase 1 clinical trials: NCT05288660, NCT05288673, NCT05288816, and NCT05288829. These studies evaluated single and multiple doses of the drug in healthy adult participants, including a subcutaneous dose study.
ALXN1210 is an investigational drug being studied for paroxysmal nocturnal hemoglobinuria (PNH). It is a small molecule in Phase 1 development, distinct from approved complement inhibitors used for PNH.