Study to Evaluate Safety, Tolerability, PK and PD of ALXN1007 in Healthy Subjects

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: ALXN1007
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cohort 1<br>0.06 mg/kg ALXN1007 | Drug: ALXN1007<br>* Single dose, IV<br>Other: Placebo<br>* Single dose, IV<br>|
| Active Comparator: Cohort 2<br>0.1 mg/kg ALXN1007 | Drug: ALXN1007<br>* Single dose, IV<br>Other: Placebo<br>* Single dose, IV<br>|
| Active Comparator: Cohort 3<br>0.3 mg/kg ALXN1007 | Drug: ALXN1007<br>* Single dose, IV<br>Other: Placebo<br>* Single dose, IV<br>|
| Active Comparator: Cohort 4<br>1.0 mg/kg ALXN1007 | Drug: ALXN1007<br>* Single dose, IV<br>Other: Placebo<br>* Single dose, IV<br>|
| Active Comparator: Cohort 5<br>3.0 mg/kg ALXN1007 | Drug: ALXN1007<br>* Single dose, IV<br>Other: Placebo<br>* Single dose, IV<br>|
| Active Comparator: Cohort 6<br>6.0 mg/kg ALXN1007 | Drug: ALXN1007<br>* Single dose, IV<br>Other: Placebo<br>* Single dose, IV<br>|
| Active Comparator: Cohort 7<br>10.0 mg/kg ALXN1007 | Drug: ALXN1007<br>* Single dose, IV<br>Other: Placebo<br>* Single dose, IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy subjects