Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALXN1007 in Healthy Male and Female Subjects
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 25 - 55 |
Updated: | 5/3/2014 |
Start Date: | June 2013 |
End Date: | September 2015 |
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.
pharmacodynamics (PD) of multiple intravenous (IV) doses of ALXN1007 in healthy male and
female subjects.
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.
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