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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01454986
First received: October 7, 2011
Last updated: November 22, 2013
Last verified: November 2013
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Estimate PK parameters of ALXN1007 using standard measures for these parameters.

  • PD parameters of ALXN1007 [ Time Frame: Up to 90 days ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01454986

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

No publications provided

Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01454986     History of Changes
Other Study ID Numbers: C11-002
Study First Received: October 7, 2011
Last Updated: November 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Alexion Pharmaceuticals:
Healthy subjects

ClinicalTrials.gov processed this record on October 23, 2014