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ALXN1101 · 1 trial · 3 indications
Physical examination, vital signs, ECGs, laboratory evaluations, and Adverse Events.
| Arm | Type | Description |
|---|---|---|
| ALXN1101 | EXPERIMENTAL | Four cohorts planned. Within each cohort, healthy volunteers are randomized to ALXN1101 IV single dose or placebo IV single dose. Each subsequent cohort is testing an increased dose of ALXN1101 IV or placebo IV. |
| Placebo | PLACEBO_COMPARATOR | Four cohorts planned. Within each cohort, healthy volunteers are randomized to ALXN1101 IV single dose or placebo IV single dose. Each subsequent cohort is testing an increased dose of ALXN1101 IV or placebo IV. |
| Name | Type | Description |
|---|---|---|
| ALXN1101 | DRUG | Randomized to receive a single dose of ALXN1101 or placebo as per assigned cohort dose level. |
| Placebo | DRUG | Randomized to receive a single dose of ALXN1101 or placebo as per assigned cohort dose level. |
Key Inclusion Criteria: 1. Male or female subjects ≥ 18 and ≤ 60 years of age and weight ≥ 55 kg and ≤ 100 kg 2. Willing and able to give written informed consent 3. Female subjects of child bearing potential must have a negative serum pregnancy test or must be practicing an approved contraceptive ...
ALXN1101 is an investigational small molecule developed by BridgeBio Pharma, Inc. (ticker BBIO) for molybdenum cofactor deficiency (MoCD), a rare autosomal recessive disorder. It has completed a Phase 1 clinical trial and is not approved for commercial use.
ALXN1101 is being developed for molybdenum cofactor deficiency (MoCD), a rare autosomal recessive disorder characterized by deficiency of molybdenum-dependent enzymes including sulfite oxidase, xanthine dehydrogenase, and aldehyde oxidase. It is investigational and has not been approved for any indication.
ALXN1101 is being developed by BridgeBio Pharma, Inc., which trades under the ticker BBIO. The company is responsible for the clinical development of this small molecule for molybdenum cofactor deficiency.
ALXN1101 is in Phase 1 development. A Phase 1 single dose study in healthy volunteers has been completed. The drug remains investigational and has not received FDA approval.
ALXN1101 has been evaluated in one completed Phase 1 clinical trial, NCT01894165, titled "Phase 1 Single Dose Study of ALXN1101 in Healthy Volunteers." The trial enrolled 24 healthy adult participants in the United States and was randomized, double-blind, and placebo-controlled.