Migraine
Conditions
Interventions
70 mg SC injection group:Single dose of 70 mg Erenumab SC injection
140 mg SC injection group:Single dose of 140 mg Erenumab SC injection
Sponsors
West China Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Signed informed consent must be obtained prior to participation in the study. 2. Chinese Healthy male or female subjects 18 to 45 years of age included, and in good health as determined by past medical history, physical and neurological examination, vital signs, electrocardiogram, and laboratory tests at Screening. 3. At screening and baseline, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position and again (when required) in the standing position as outlined in the SOM. Sitting vital signs should be within the following ranges: Body temperature between 35.0-37.2 degree C; Systolic blood pressure, 90-139 mmHg; Diastolic blood pressure, 50-89 mmHg; Pulse rate, 50-99 bpm; Subjects should be excluded if their standing vital signs (relative to sitting) show findings which, in the opinion of the Investigator, are associated with clinical manifestation of postural hypotension (i.e. absence of any other cause). The Investigator should carefully consider enrolling subjects with either a > 20 mmHg decrease in systolic or a >10 mm Hg decrease in diastolic blood pressure, accompanied by a > 20 bpm increase in pulse rate (from sitting to standing). If vital signs are outside these ranges, the Investigator should obtain two additional readings, so that a total of three consecutive assessments are made, following the procedure in the SOM. 4. Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 30 kg/m2 (Inclusive). BMI = Body weight (kg) / [Height (m)]2 (at screening visit). 5. Able to communicate well with the investigator, to understand and comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Use of other investigational drugs within 5 half-lives, or within 30 days of screening, or until the expected PD effect has returned to baseline, whichever is longer, or longer if required by local regulations. 2. History of hypersensitivity or allergic reaction to CGRP receptor antagonist to any of the study treatments or excipients or to drugs, of similar chemical classes. 3. Subject previously has entered this study or has been previously exposed to erenumab. 4. Current or former clinically significant ECG abnormalities, including: QTcF > 450 msec (males) QTcF > 460 msec (females) 5. Known family history or known presence of long QT syndrome. 6. Known history or current clinically significant arrhythmias. 7. Concomitant use of agents known to prolong the QT interval unless they can be permanently discontinued for the duration of study. 8. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer), treated or untreated, within 5 years of screening, regardless of whether there is evidence of local recurrence or metastases. 9. A history of hypertension, hypotension, symptomatic or asymptomatic coronary artery disease, coronary artery bypass surgery, percutaneous transluminal coronary angioplasty procedure, and any cerebrovascular event including but not limited to cerebrovascular accident, transient ischemic attack, or peripheral vascular disease including Raynaud's disease. 10. Removed with protocol amendment 1. 11. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test at screening. 12. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 110 days (= 5 times the terminal half-life) after stopping of investigational drug. Highly effective contraception methods include: Total abstinence from heterosexual intercourse (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks before taking investigational drug. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment. Male sterilization (at least 6 months prior to screening). For female subjects on the study the vasectomized male partner should be the sole partner for that subject. Use of oral (estrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception, women should be stable on the same pill for a minimum of 3 months before taking investigational drug. If local regulations deviate from the contraception methods listed above and require more extensive measures to prevent pregnancy, local regulations apply and will be described in the ICF. Women are consi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum concentrations of erenumab after a single;PK parameters: AUClast, AUCinf, Cmax, Tmax after a single SC dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| AE, ECG parameters, safety laboratory, vital signs, neurological examination and SAE;Anti-erenumab antibodies; | — |
Countries
China
Contacts
Public ContactQi Shen
West China Hospital of Sichuan University
Outcome results
None listed