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OpenTrials
Completed

NCT Number: NCT01454986

Study to Evaluate Safety, Tolerability, PK and 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.

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Key information

Conditions

Healthy

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PAREXEL Baltimore EPCU

Baltimore, Maryland, 21225, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ALXN1007

Drug

Single dose, IV

Placebo

Other

Single dose, IV

Primary outcomes

  1. 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 outcomes

  1. PK parameters of ALXN1007

    Time frame: Up to 90 days

    Estimate PK parameters of ALXN1007 using standard measures for these parameters.

  2. PD parameters of ALXN1007

    Time frame: Up to 90 days

    Identify PD effects of ALXN1007 by assessing standard complement measures for these parameters.

Sponsors and collaborators

Lead sponsor

Alexion Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 19, 2011
Registry last updated
Feb 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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