Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single-dose Injection of SHR-2004 in Healthy Subjects

Beijing Suncadia Pharmaceuticals

Status and phase: Active, not recruiting; Phase 1

Conditions: Prevention of Arterial and Venous Thrombosis

Treatments: Drug: SAD, SHR-2004 placebo; Drug: SAD, SHR-2004

Study type: Interventional

Funder types: Industry

Identifiers

NCT05369767

SHR-2004-101

Details and patient eligibility

About

The primary objective of this study is to assess the safety and tolerability of SHR-2004 injection in healthy subjects. In addition, this study will provide information on pharmacokinetics and pharmacodynamics of SHR-2004 injection in healthy subjects.

Enrollment: 64 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. males or females, aged 18-55;
2. body mass index (BMI) between 19 kg/m2 to 28 kg/m2, and a total body weight: male ≥50.0 kg and <90.0 kg; female ≥45.0 kg and <90.0 kg.

Exclusion criteria

1. previous medical history of coagulation or bleeding disorders;
2. known risks of bleeding or thrombosis, such as recurrent gingival bleeding, spontaneous bleeding, haemorrhoids, gastrointestinal ulcers, or other high-risk bleeding diseases.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 2 patient groups, including a placebo group

SAD, SHR-2004

Experimental group

Description:

Up to 6 cohorts of healthy subjects will receive a single dose of SHR-2004 injection

Treatment:

Drug: SAD, SHR-2004

SAD, SHR-2004 placebo

Placebo Comparator group

Description:

Up to 6 cohorts of healthy subjects will receive a single dose of SHR-2004 placebo injection

Treatment:

Drug: SAD, SHR-2004 placebo