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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01454986
First Posted: October 19, 2011
Last Update Posted: February 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alexion Pharmaceuticals
  Purpose
The purpose of the study is to evaluate the safety, tolerability, PK and PD of a single-dose of ALXN1007 in healthy volunteers.

Condition Intervention Phase
Healthy Drug: ALXN1007 Other: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Alexion Pharmaceuticals:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • PK parameters of ALXN1007 [ Time Frame: Up to 90 days ]
    Estimate PK parameters of ALXN1007 using standard measures for these parameters.

  • PD parameters of ALXN1007 [ Time Frame: Up to 90 days ]
    Identify PD effects of ALXN1007 by assessing standard complement measures for these parameters.


Enrollment: 64
Study Start Date: November 2011
Study Completion Date: October 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01454986


Locations
United States, Maryland
PAREXEL Baltimore EPCU
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Alexion Pharmaceuticals
  More Information

Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01454986     History of Changes
Other Study ID Numbers: C11-002
First Submitted: October 7, 2011
First Posted: October 19, 2011
Last Update Posted: February 3, 2017
Last Verified: February 2017

Keywords provided by Alexion Pharmaceuticals:
Healthy subjects


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