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

Source Origin Biosciences
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 single dose of ALXN1101 in healthy adult subjects.

Overall Status Completed
Start Date June 2013
Completion Date September 2013
Primary Completion Date September 2013
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Safety and tolerability of single dose of ALXN1101 in healthy adult subjects following the Day 30 visit for the last study subject
Secondary Outcome
Measure Time Frame
PK parameters of ALXN1101 following the Day 5 visit for the last study subject
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

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

Overall Official
Last Name Role Affiliation
Ronald Goldwater, MD Principal Investigator Parexel Baltimore Early Phase Clinical Unit
Location
Facility: Parexel Baltimore EPCU
Location Countries

United States

Verification Date

March 2019

Responsible Party

Type: Sponsor

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.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov