Status:
COMPLETED
Phase 1 Single Dose Study of ALXN1101 in Healthy Volunteers
Lead Sponsor:
Origin Biosciences
Conditions:
Molybdenum Cofactor Deficiency (MoCD)
Rare Autosomal Recessive Disorder
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief 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 sing...
Eligibility Criteria
Inclusion
- Key
- Male or female subjects ≥ 18 and ≤ 60 years of age and weight ≥ 55 kg and ≤ 100 kg
- Willing and able to give written informed consent
- Female subjects of child bearing potential must have a negative serum pregnancy test or must be practicing an approved contraceptive regimen for the duration of the study
- Male subjects must be practicing an acceptable barrier method of contraception
- Key
Exclusion
- Pregnant or nursing female subjects
- QTcF \> 450 msec for males and \> 470 msec for females, or a family history of Long QT Syndrome.
- CrCl \< 80 mL/min
- CBC in acceptable range; SGOT or SGPT above the ULN
- HIV, Hepatitis B or Hepatitis C virus infection
- Other active systemic infection or malignancy
- Investigational drug study within 60 days
- Major surgery within the prior 90 days
- History of illicit drug use or chronic alcohol dependence within 2 years prior to this study
- Positive urine drug toxicology screen or serum alcohol test
- Alcohol consumption within 48 hours prior to study drug administration
- Recently donated or lost ≥ 499 mL of blood
- Recent hormone replacement therapy or use of prescription medications
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01894165
Start Date
June 1 2013
End Date
September 1 2013
Last Update
March 19 2019
Active Locations (1)
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1
Parexel Baltimore EPCU
Baltimore, Maryland, United States, 21225