A Trial to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety and Tolerability of Zerlasiran in Japanese Subjects With Elevated Serum Lipoprotein(a)

JRCT ID: jRCT2051240068

Registered date:18/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Japanese subjects with elevated Lp(a)
• Date of first enrollment: 16/05/2024
• Target sample size: 24
• Study type: Interventional
• Intervention(s): A single dose of up to 4 different doses across up to 4 cohorts

Outcome(s)

• Primary Outcome: The PK parameters of zerlasiran following single subcutaneous administration of up to 4 different doses

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 70age old
• Gender: Both

Include criteria

- Males or nonpregnant, nonlactating females who are 20 to 70 years of age.
- Body mass index at least 18 kg/m2 but no more than 32 kg/m2
- Elevated Lp(a) in the blood
- Agrees to use effective contraception, if applicable

Exclude criteria

- Patients have a history of established cardiovascular disease.
- Patients with a history of cancer
- Patients with moderate or serious liver conditions
- Patients with serious mental illness or psychiatric disorder
- Positive for hepatitis B, hepatitis C and/or human immunodeficiency virus (HIV)
- History or clinical evidence of alcohol misuse and/or illegal drug use within the 6 months before Screening
- History of multiple drug allergies
- History of intolerance to subcutaneous injections (hypersensitivity etc.) or scarring in skin areas where subcutaneous doses may need to be administered.
- Type 1 diabetes mellitus or poorly controlled (glycated haemoglobin 10% and over or 86 mmol/mol and over) type 2 diabetes mellitus

Related Information

• Primary Sponsor: Fok Henry