Study to Evaluate Safety, Tolerability, PK and PD of ALXN1007 in Healthy Subjects
This study is currently recruiting participants.
Verified July 2012 by Alexion Pharmaceuticals
Sponsor:
Alexion Pharmaceuticals
Information provided by (Responsible Party):
Alexion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01454986
First received: October 7, 2011
Last updated: July 10, 2012
Last verified: July 2012
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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.
| Estimated Enrollment: | 56 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | December 2012 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01454986
Contacts
| Contact: Annette Valles-Sukkar, MHP, MT, CCRA | 617-299-3124 | Valles-SukkarA@alxn.com |
| Contact: Bill Lundberg, MD | 617-299-3125 | LundbergB@alxn.com |
Locations
| United States, Maryland | |
| PAREXEL Baltimore EPCU | Recruiting |
| Baltimore, Maryland, United States, 21225 | |
| Contact: Ivan Kostov Ivan.Kostov@parexel.com | |
| Contact 877-617-8839 | |
| Principal Investigator: Ronald Goldwater, MD | |
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: | July 10, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Alexion Pharmaceuticals:
|
Healthy subjects |
ClinicalTrials.gov processed this record on May 19, 2013