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

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

Fok Henry

Silence Therapeutics plc

72 Hammersmith Road, London, W14 8TH, United Kingdom

h.fok@silence-therapeutics.com

Cardona Ritsuko

Medpace Japan K.K.

1-5-8, Jingumae, Shibuya-ku, Tokyo

+81-3-4563-7000

RSJapan1@medpace.com

Complete

April. 26, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

other

- 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

- 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

Both

Japanese subjects with elevated Lp(a)

A single dose of up to 4 different doses across up to 4 cohorts

The PK parameters of zerlasiran following single subcutaneous administration of up to 4 different doses

+81-6-6395-9000

April. 19, 2024

No

none