Trials / Completed
CompletedNCT01894165
Phase 1 Single Dose Study of ALXN1101 in Healthy Volunteers
A Phase 1, Randomized, Blinded, Placebo-Controlled, Single-Dose, Sequential-Cohort, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ALXN1101 in Healthy Adult Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Origin Biosciences · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
Phase 1 single dose study of ALXN1101 in healthy volunteers.
Detailed description
This is a first-in-human (FIH), randomized, blinded, placebo-controlled, single-dose, sequential-cohort, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics (PK) of a single dose of ALXN1101 in healthy adult subjects.
Conditions
- Molybdenum Cofactor Deficiency (MoCD)
- Rare Autosomal Recessive Disorder
- Deficiency of Activity of Molybdenum-dependent Enzymes (Sulfite Oxidase [SOX], Xanthine Dehydrogenase, and Aldehyde Oxidase)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ALXN1101 | Randomized to receive a single dose of ALXN1101 or placebo as per assigned cohort dose level. |
| DRUG | Placebo | Randomized to receive a single dose of ALXN1101 or placebo as per assigned cohort dose level. |
Timeline
- Start date
- 2013-06-01
- Primary completion
- 2013-09-01
- Completion
- 2013-09-01
- First posted
- 2013-07-10
- Last updated
- 2019-03-19
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01894165. Inclusion in this directory is not an endorsement.