Study to Evaluate Safety, Tolerability, PK and PD of ALXN1007 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ALXN1007; Other: Placebo

• Registration Number: NCT01454986
• Lead Sponsor: Alexion Pharmaceuticals, Inc.

Brief Summary

The purpose of the study is to evaluate the safety, tolerability, PK and PD of a single-dose of ALXN1007 in healthy volunteers.

Detailed Description

All subjects will be screened for eligibility after providing signed informed consent. Once a subject is determined to be eligible, the subject will be vaccinated with the quadrivalent meningococcal conjugate vaccine at least two weeks prior to dosing, if applicable. A total of 7 dose cohorts will be enrolled sequentially and randomized to receive ALXN1007 or placebo. Subjects will receive ALXN1007 or placebo at the clinic and be kept at the clinic for a total of 4 days for observation and completion of the required study tests.

The subjects will return for 8 additional clinic visits to complete the required study tests over the next 86 days. The total duration of the study is 90 days from the day of dosing with ALXN1007 or placebo.

Study Timeline

• Study First Submitted: 2011-10-07
• Study First Submitted QC: 2011-10-18
• Study First Posted: 2011-10-19
• Study Start: 2011-11
• Primary Completion: 2013-08
• Study Completion: 2013-10
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-02
• Last Update Posted: 2017-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Healthy individuals 25 to 55 years of age with documented vaccination with MCV4.

Exclusion Criteria

• Abnormal renal or liver function.
• History of meningococcal disease.
• History of Guillain-Barre syndrome.
• Known infection with HIV or Hepatitis B or C.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	Placebo	0.06 mg/kg ALXN1007
Cohort 2	ALXN1007	0.1 mg/kg ALXN1007
Cohort 1	ALXN1007	0.06 mg/kg ALXN1007
Cohort 3	ALXN1007	0.3 mg/kg ALXN1007
Cohort 4	Placebo	1.0 mg/kg ALXN1007
Cohort 5	Placebo	3.0 mg/kg ALXN1007
Cohort 3	Placebo	0.3 mg/kg ALXN1007
Cohort 6	Placebo	6.0 mg/kg ALXN1007
Cohort 2	Placebo	0.1 mg/kg ALXN1007
Cohort 7	ALXN1007	10.0 mg/kg ALXN1007
Cohort 7	Placebo	10.0 mg/kg ALXN1007
Cohort 4	ALXN1007	1.0 mg/kg ALXN1007
Cohort 5	ALXN1007	3.0 mg/kg ALXN1007
Cohort 6	ALXN1007	6.0 mg/kg ALXN1007

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of a single dose of ALXN1007.	Up to 90 days	Safety and tolerability of a single dose of ALXN1007 assessed by physical exam, vital signs, ECG, immunogenicity, lab analysis and adverse events.

Secondary Outcome Measures

Name	Time	Method
PD parameters of ALXN1007	Up to 90 days	Identify PD effects of ALXN1007 by assessing standard complement measures for these parameters.
PK parameters of ALXN1007	Up to 90 days	Estimate PK parameters of ALXN1007 using standard measures for these parameters.

Trial Locations

Locations (1)

PAREXEL Baltimore EPCU; 🇺🇸 Baltimore, Maryland, United States