Phase 1 Single Dose Study of ALXN1101 in Healthy Volunteers

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase 1 single dose study of ALXN1101 in healthy volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alexion Pharma GmbH; Origin Biosciences
• Treatments: Molybdenum

Criteria

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 regimen for the duration of the study

4. Male subjects must be practicing an acceptable barrier method of contraception

Key Exclusion Criteria:

1. Pregnant or nursing female subjects

2. QTcF > 450 msec for males and > 470 msec for females, or a family history of Long QT Syndrome.

3. CrCl < 80 mL/min

4. CBC in acceptable range; SGOT or SGPT above the ULN

5. HIV, Hepatitis B or Hepatitis C virus infection

6. Other active systemic infection or malignancy

7. Investigational drug study within 60 days

8. Major surgery within the prior 90 days

9. History of illicit drug use or chronic alcohol dependence within 2 years prior to this study

10. Positive urine drug toxicology screen or serum alcohol test

11. Alcohol consumption within 48 hours prior to study drug administration

12. Recently donated or lost ≥ 499 mL of blood

13. Recent hormone replacement therapy or use of prescription medications