Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ALXN1820 · 1 trial · 1 indication
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 any AEs that commenced after the start of administration of study intervention. Serious AEs (SAEs) were defined as any untoward medical occurrence that met at least 1 of the following serious criteria: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, other medically important serious event. A summary of all SAEs and Other AEs (nonserious) regardless of causality is located in the 'Reported AEs' Section.
| Arm | Type | Description |
|---|---|---|
| ALXN1820 | EXPERIMENTAL | Participants will receive ALXN1820 SC or ALXN1820 IV according to their assigned cohort. ALXN1820 SC will be evaluated in single and multiple ascending doses while ALXN1820 IV will be evaluated in a single dose cohort only. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive Placebo SC or Placebo IV according to their assigned cohort. |
| Name | Type | Description |
|---|---|---|
| ALXN1820 SC | DRUG | ALXN1820 SC will be administered as a manual SC push or SC infusion via a syringe pump. Doses will range from 12.5 milligrams (mg) to a maximum of 2250 mg. Multiple dosing duration will range from 3 to 5 weeks. |
| ALXN1820 IV | DRUG | ALXN1820 IV (450 mg) will be administered as an IV infusion. |
| Placebo SC | DRUG | Placebo SC will be administered as a manual SC push or SC infusion via a syringe pump. |
| Placebo IV | DRUG | Placebo IV will be administered as an IV infusion. |
Inclusion Criteria: * Body weight 50 to 100 kilograms (kg); body mass index 17 to 32 kg/meter squared. * Cohort 9 only: Japanese participants (defined as those participants whose parents and grandparents are both Japanese and who have spent less than 5 years outside of Japan). * Satisfactory medica...
ALXN1820 is an investigational small molecule being studied in healthy adult participants. It is currently in Phase 1 clinical development, with a completed trial evaluating its safety and tolerability in healthy volunteers. The drug is not approved for any indication and remains under investigation.
ALXN1820 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The company is conducting clinical research on this investigational small molecule in healthy participants.
ALXN1820 is in Phase 1 clinical development. A Phase 1 study in healthy adult participants has been completed. The drug is investigational and has not been approved by regulatory authorities for any use.
ALXN1820 has one completed clinical trial, identified as NCT04631562, titled 'Study of ALXN1820 in Healthy Adult Participants.' This Phase 1 study enrolled 66 healthy volunteers and was conducted in Australia and the United Kingdom.
ALXN1820 is the primary name for this investigational small molecule. No alternative names have been reported for this drug in clinical development. It is being studied under this identifier in the completed Phase 1 trial.