Eligibility Details:
Inclusion Criteria:
- For cohorts that enroll non-Asian subjects, subject does not have East Asian (China,
Hong Kong, Macau, Japan, Mongolia, North Korea, South Korea and Taiwan) ancestries.
- For cohorts that enroll Japanese subjects, subject is first generation Japanese, born
in Japan with 4 grandparents of Japanese descent, and must have resided outside of
Japan for ≤ 10 years.
- Subject has a body mass index (BMI) range of 18.5 to 32.0 kg/m2, inclusive and weighs
at least 50 kg at screening.
- Female subject is not pregnant and at least 1 of the following conditions apply:
- Not a woman of childbearing potential (WOCBP)
- WOCBP who agrees to follow the contraceptive guidance from the time of informed
consent through at least 30 days after final investigational product (IP)
administration.
- Female subject must agree not to breastfeed starting at screening and throughout the
study period and for 30 days after final IP administration.
- Female subject must not donate ova starting at first dose of IP and throughout the
study period and for 30 days after final IP administration.
- Male subject with female partner(s) of child-bearing potential (including
breastfeeding partner[s]) must agree to use contraception throughout the treatment
period and for 30 days after final IP administration.
- Male subject must not donate sperm during the treatment period and for 30 days after
final IP administration.
- Male subject with pregnant partner(s) must agree to remain abstinent or use a condom
for the duration of the pregnancy throughout the study period and for 30 days after
final IP administration.
- Subject agrees not to participate in another interventional study while participating
in the present study.
Exclusion Criteria:
- Subject has received any investigational therapy within 28 days or 5 half-lives,
whichever is longer, prior to screening.
- Subject has any condition, which makes the subject unsuitable for study participation.
- Female subject who has been pregnant within 6 months prior to screening or
breastfeeding within 3 months prior to screening.
- Subject has a known or suspected hypersensitivity to ASP1617 or any components of the
formulation used.
- Subject has had previous exposure with ASP1617.
- Subject has any of the liver function tests (alkaline phosphatase [ALP], ALT, AST,
gamma glutamyl transferase and TBL) above the upper linit of normal (ULN) on day -1.
In such a case, the assessment may be repeated once.
- Subject has creatinine level outside normal limits on day -1. In such a case, the
assessment may be repeated once.
- Subject has any clinically significant history of allergic conditions (including drug
allergies, asthma, eczema or anaphylactic reactions, but excluding untreated,
asymptomatic, seasonal allergies) prior to first IP administration.
- Subject has any history or evidence of any clinically significant cardiovascular,
gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic,
urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major
disease or malignancy.
- Subject has/had febrile illness or symptomatic, viral, bacterial or fungal infection
within 1 week prior to day -1.
- Subject has any clinically significant abnormality following the physical examination,
ECG and protocol-defined clinical laboratory tests at screening or on day -1.
- Subject has a mean pulse < 45 or > 90 bpm; mean systolic blood pressure (SBP)140 mmHg;
mean diastolic blood pressure (DBP) > 90 mmHg (measurements taken in triplicate after
subject has been resting in the supine position for at least 5 minutes; pulse will be
measured automatically) on day -1. If the mean blood pressure exceeds the limits
above, 1 additional triplicate may be taken.
- Subject has a mean QTcF of > 430 msec (for male subjects) and > 450 msec (for female
subjects) on day -1. If the mean QTcF exceeds the limits above, 1 additional
triplicate ECG may be taken.
- Subject has used any prescribed or nonprescribed drugs in the 2 weeks prior to first
IP administration, except for occasional use of acetaminophen (up to 2 g/day) topical
dermatological products, including corticosteroid products, hormonal contraceptives or
hormone replacement therapy (HRT).
- Subject has smoked, used tobacco-containing products and nicotine or
nicotine-containing products (e.g., electronic vapes) within 6 months prior to
screening.
- Subject has a history of consuming > 14 units for male subjects or > 7 units for
female subjects of alcoholic beverages per week within 6 months prior to screening or
has a history of alcoholism or drug/chemical/substance abuse within 2 years prior to
screening or the subject tests positive for alcohol at screening or on day -1.
- Subject has used any drugs of abuse within 3 months prior to day -1 or the subject
tests positive for drugs of abuse at screening or on day -1.
- Subject has used any inducer of metabolism in the 3 months prior to day -1.
- Subject has had significant blood loss, donated ≥ 1 unit (450 mL) of whole blood or
donated plasma within 7 days prior to day -1 and/or received a transfusion of any
blood or blood products within 60 days.
- Subject has a positive serology test for hepatitis A virus (HAV) antibodies, hepatitis
B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or antibodies to human
immunodeficiency virus (HIV) type 1 and/or type 2 at screening.
- Subject is an employee of Astellas, the study-related contract research organizations
(CROs) or the clinical unit.
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-no
