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
| Sponsors |
Lead Sponsor: Origin Biosciences |
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| Source | Origin Biosciences | ||||||
| Brief Summary | Phase 1 single dose study of ALXN1101 in healthy volunteers. |
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| 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. |
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| Overall Status | Completed | ||||||
| Start Date | June 2013 | ||||||
| Completion Date | September 2013 | ||||||
| Primary Completion Date | September 2013 | ||||||
| Phase | Phase 1 | ||||||
| Study Type | Interventional | ||||||
| Primary Outcome |
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| Secondary Outcome |
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| Enrollment | 24 | ||||||
| Condition | |||||||
| Intervention |
Intervention Type: Drug Intervention Name: ALXN1101 Description: Randomized to receive a single dose of ALXN1101 or placebo as per assigned cohort dose level. Arm Group Label: ALXN1101 Intervention Type: Drug Intervention Name: Placebo Description: Randomized to receive a single dose of ALXN1101 or placebo as per assigned cohort dose level. Arm Group Label: Placebo |
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| Eligibility |
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 Gender: All Minimum Age: 18 Years Maximum Age: 60 Years Healthy Volunteers: Accepts Healthy Volunteers |
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| Overall Official |
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| Location |
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| Location Countries |
United States |
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| Verification Date |
March 2019 |
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| Responsible Party |
Type: Sponsor |
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| Keywords | |||||||
| Has Expanded Access | No | ||||||
| Number Of Arms | 2 | ||||||
| Arm Group |
Label: ALXN1101 Type: Experimental Description: 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. Label: Placebo Type: Placebo Comparator Description: 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. |
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| Study Design Info |
Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Treatment Masking: Double (Participant, Investigator) |
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