Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALXN1007 in Healthy Male and Female Subjects

A Phase 1, Randomized, Blinded, Placebo-Controlled, Multiple IV Administration, Sequential-Cohort, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALXN1007 in Healthy Male and Female Subjects

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple intravenous (IV) doses of ALXN1007 in healthy male and female subjects.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: ALXN1007

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21225
      • PAREXEL Baltimore EPCU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Healthy male or female (not of childbearing potential) subjects ≥25 and ≤55 years old.

2. QTcF ≤450 msec and ≤470 for females. 3. Willing and able to give written informed consent and comply with the study visit schedule.

4. Male subject and his female spouse/partner who is of childbearing potential must be using highly effective congraception1 consisting of two forms of birth control (at least one of which must be a barrier method) starting at Screening and continuing until the end of study.

1. Highly effective contraception is defined as:

   • Established use of oral, injected or implanted hormonal methods of contraception.
   • Placement of an intrauterine device or intrauterine system.

   • Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.

     5. Male subjects must not donate sperm starting at Screening until the end of study.

     6. Documented vaccination with meningococcal conjugate vaccine (MCV4) at least 14 days and not more than 5 years, prior to dosing.

Exclusion Criteria:

Female subjects of childbearing potential, including any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal. Postmenopausal is defined as:

• Amenorrhea ≥ 12 consecutive months without another cause and a documented serum follicle stimulating hormone (FSH) level >35 mIU/mL or
• Female subjects with irregular menstrual periods and a documented serum FSH level > 35 mIU/mL.

• Women on hormone replacement therapy (HRT). Women who are using oral contraceptives, other hormonal contraceptives (i.e., vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (i.e., diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential.

  2. Positive serum pregnancy test at Screening or Day -1. 3. Serum creatinine great than the upper limit of normal (ULN) of the testing laboratory at Screening and Day -1.

  4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >ULN of the testing laboratory at Screening and Day -1.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ALXN1007; Infusion of ALXN1007	Drug: ALXN1007
PLACEBO_COMPARATOR: placebo; Infusion placebo	Drug: ALXN1007

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate the safety and tolerability of multiple, IV doses of ALXN1007 in healthy male and female subjects as assessed by physical exam, vital signs, electrocardiogram (ECG), immunogenicity, laboratory analysis, and assessment of adverse events (AEs	90 days follow-up

Collaborators and Investigators

• Sponsor: Alexion Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ACTUAL): January 1, 2014

Study Registration Dates

• First Submitted: June 19, 2013
• First Submitted That Met QC Criteria: June 20, 2013
• First Posted (ESTIMATE): June 21, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): March 31, 2014
• Last Update Submitted That Met QC Criteria: March 28, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Safety; Pharmacokinetics; Tolerability; Pharmacodynamics; ALXN1007; Healthy Male and Female Subjects
• Other Study ID Numbers: ALXN1007-US-HV-102