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

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ClinicalTrials.gov Identifier: NCT01883544
Recruitment Status : Completed
First Posted : June 21, 2013
Last Update Posted : March 31, 2014
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: ALXN1007 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : January 2014

Arm Intervention/treatment
Experimental: ALXN1007
Infusion of ALXN1007
Drug: ALXN1007
Placebo Comparator: placebo
Infusion placebo
Drug: ALXN1007



Primary Outcome Measures :
  1. 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 [ Time Frame: 90 days follow-up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01883544


Locations
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United States, Maryland
PAREXEL Baltimore EPCU
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Alexion Pharmaceuticals

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Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01883544     History of Changes
Other Study ID Numbers: ALXN1007-US-HV-102
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: March 31, 2014
Last Verified: March 2014
Keywords provided by Alexion Pharmaceuticals:
Safety
Tolerability
Pharmacokinetics
Pharmacodynamics
ALXN1007
Healthy Male and Female Subjects