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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01454986

Enrollment

Registered

2011-10-19

Start date

2011-11-30

Completion date

2013-10-31

Last updated

2017-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy subjects

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.

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.

Interventions

DRUGALXN1007

Single dose, IV

OTHERPlacebo

Single dose, IV

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

25 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Safety and tolerability of a single dose of ALXN1007.	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

Measure	Time frame	Description
PK parameters of ALXN1007	Up to 90 days	Estimate PK parameters of ALXN1007 using standard measures for these parameters.
PD parameters of ALXN1007	Up to 90 days	Identify PD effects of ALXN1007 by assessing standard complement measures for these parameters.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026