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

February 2, 2017 updated by: Alexion

A Phase 1, Randomized, Blinded, Placebo-Controlled, Single-Administration, Sequential-Cohort Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of ALXN1007 in Healthy Subjects

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21225
        • PAREXEL Baltimore EPCU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cohort 1
0.06 mg/kg ALXN1007
Drug: ALXN1007
Single dose, IV
Other: Placebo
Single dose, IV
Active Comparator: Cohort 2
0.1 mg/kg ALXN1007
Drug: ALXN1007
Single dose, IV
Other: Placebo
Single dose, IV
Active Comparator: Cohort 3
0.3 mg/kg ALXN1007
Drug: ALXN1007
Single dose, IV
Other: Placebo
Single dose, IV
Active Comparator: Cohort 4
1.0 mg/kg ALXN1007
Drug: ALXN1007
Single dose, IV
Other: Placebo
Single dose, IV
Active Comparator: Cohort 5
3.0 mg/kg ALXN1007
Drug: ALXN1007
Single dose, IV
Other: Placebo
Single dose, IV
Active Comparator: Cohort 6
6.0 mg/kg ALXN1007
Drug: ALXN1007
Single dose, IV
Other: Placebo
Single dose, IV
Active Comparator: Cohort 7
10.0 mg/kg ALXN1007
Drug: ALXN1007
Single dose, IV
Other: Placebo
Single dose, IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability of a single dose of ALXN1007.
Time Frame: 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.
Up to 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PK parameters of ALXN1007
Time Frame: Up to 90 days
Estimate PK parameters of ALXN1007 using standard measures for these parameters.
Up to 90 days
PD parameters of ALXN1007
Time Frame: Up to 90 days
Identify PD effects of ALXN1007 by assessing standard complement measures for these parameters.
Up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

October 7, 2011

First Submitted That Met QC Criteria

October 18, 2011

First Posted (Estimate)

October 19, 2011

Study Record Updates

Last Update Posted (Estimate)

February 3, 2017

Last Update Submitted That Met QC Criteria

February 2, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • C11-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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