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

October 7, 2011
November 22, 2013
November 2011
August 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01454986 on ClinicalTrials.gov Archive Site
  • 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.
PK parameters of ALXN1007 [ Time Frame: Up to 90 days ] [ Designated as safety issue: No ]

Estimate PK parameters of ALXN1007 including but not limited terminal half-life, total body clearance, steady-state volume of distribution, time to maximum observed plasma concentration vs. time curve between 0 and infinity.

Identify PD effects of ALXN1007 be assessing plasma concentrations of C5, C5a,C3a, sC5b-9; serum chicken RBC hemolysis activity, CCP activity,and CH50-Eq.

Not Provided
Not Provided
 
Study to Evaluate Safety, Tolerability, PK and PD of ALXN1007 in Healthy Subjects
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Healthy
  • Drug: ALXN1007
    Single dose, IV
  • Other: Placebo
    Single dose, IV
  • Active Comparator: Cohort 1
    0.06 mg/kg ALXN1007
    Interventions:
    • Drug: ALXN1007
    • Other: Placebo
  • Active Comparator: Cohort 2
    0.1 mg/kg ALXN1007
    Interventions:
    • Drug: ALXN1007
    • Other: Placebo
  • Active Comparator: Cohort 3
    0.3 mg/kg ALXN1007
    Interventions:
    • Drug: ALXN1007
    • Other: Placebo
  • Active Comparator: Cohort 4
    1.0 mg/kg ALXN1007
    Interventions:
    • Drug: ALXN1007
    • Other: Placebo
  • Active Comparator: Cohort 5
    3.0 mg/kg ALXN1007
    Interventions:
    • Drug: ALXN1007
    • Other: Placebo
  • Active Comparator: Cohort 6
    6.0 mg/kg ALXN1007
    Interventions:
    • Drug: ALXN1007
    • Other: Placebo
  • Active Comparator: Cohort 7
    10.0 mg/kg ALXN1007
    Interventions:
    • Drug: ALXN1007
    • Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
October 2013
August 2013   (final data collection date for primary outcome measure)

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.
Both
25 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01454986
C11-002
Yes
Alexion Pharmaceuticals
Alexion Pharmaceuticals
Not Provided
Not Provided
Alexion Pharmaceuticals
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP