NCT01454986

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Nov 2011

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 19, 2011

Completed
13 days until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

February 3, 2017

Status Verified

February 1, 2017

Enrollment Period

1.8 years

First QC Date

October 7, 2011

Last Update Submit

February 2, 2017

Conditions

Healthy

Keywords

Healthy subjects

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of a single dose of ALXN1007.

    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 Outcomes (2)

  • PK parameters of ALXN1007

    Up to 90 days

  • PD parameters of ALXN1007

    Up to 90 days

Study Arms (7)

Cohort 1

ACTIVE COMPARATOR

0.06 mg/kg ALXN1007

Drug: ALXN1007Other: Placebo

Cohort 2

ACTIVE COMPARATOR

0.1 mg/kg ALXN1007

Drug: ALXN1007Other: Placebo

Cohort 3

ACTIVE COMPARATOR

0.3 mg/kg ALXN1007

Drug: ALXN1007Other: Placebo

Cohort 4

ACTIVE COMPARATOR

1.0 mg/kg ALXN1007

Drug: ALXN1007Other: Placebo

Cohort 5

ACTIVE COMPARATOR

3.0 mg/kg ALXN1007

Drug: ALXN1007Other: Placebo

Cohort 6

ACTIVE COMPARATOR

6.0 mg/kg ALXN1007

Drug: ALXN1007Other: Placebo

Cohort 7

ACTIVE COMPARATOR

10.0 mg/kg ALXN1007

Drug: ALXN1007Other: Placebo

Interventions

ALXN1007DRUG

Single dose, IV

Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5Cohort 6Cohort 7
PlaceboOTHER

Single dose, IV

Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5Cohort 6Cohort 7

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy individuals 25 to 55 years of age with documented vaccination with MCV4.

You may not qualify if:

  • Abnormal renal or liver function.
  • History of meningococcal disease.
  • History of Guillain-Barre syndrome.
  • Known infection with HIV or Hepatitis B or C.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PAREXEL Baltimore EPCU

Baltimore, Maryland, 21225, United States

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2011

First Posted

October 19, 2011

Study Start

November 1, 2011

Primary Completion

August 1, 2013

Study Completion

October 1, 2013

Last Updated

February 3, 2017

Record last verified: 2017-02

Locations

US(1)