A Study to Evaluate Pharmacokinetics of Sonazoid™ Following Intravenous Bolus Injection in Healthy Volunteers

Inclusion criteria

Participants may be included in the study if they meet all of the following criteria:

• Participant is between 18 and 45 years of age
• Participant is male, or a female who was either surgically sterile (has a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), or non-lactating, or if of childbearing potential the results of a serum or urine human chorionic gonadotropin pregnancy test, performed on the day of Sonazoid™ administration (with the result known before IMP administration), were negative
• Participant is able and willing to comply with study procedures and provide signed and dated informed consent
• Participant has a body mass index of 19 to 26
• Participant has agreed not to smoke from 2 hours before to 5 hours after Sonazoid™ administration
• Participant has agreed to avoid strenuous physical activity from 1 week before Sonazoid™ administration until the end of the study follow-up
• Participant has no history of alcohol or substance abuse, and has agreed to no intake of alcohol or drugs for 48 hours before Sonazoid™ administration and until the end of the study follow-up
• Participant has a normal health status, as judged by medical history and physical examination at screening
• Normal 12-lead electrocardiogram (ECG) at screening. Minor abnormalities considered by the investigator to be of no clinical importance are permitted
• Normal blood and urine clinical chemistry variables at screening. Isolated or minimally out-of-range values considered by the investigator to be of no clinical importance are permitted
• No regular use of concomitant medication, except for routine use of supplemental oestrogen

Exclusion criteria

• Participant was previously included in this study
• Participation in another clinical trial with an unregistered medicinal product, or less than 30 days have passed since completing participation in such a trial
• Participant has a history of allergies to eggs or egg products (i.e., manifested by full body rash, respiratory difficulty, oral and laryngeal swelling, hypotension or shock)
• Donation of >500 milliliter (mL) blood in the 12 weeks before Sonazoid™ administration
• Participant with congenital heart defects, including right-to-left, bi-directional, or transient right-to-left cardiac shunts
• Participant has positive test results for hepatitis B, hepatitis C, or human immunodeficiency virus