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

Beijing Suncadia Pharmaceuticals Co., Ltd64 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Prevention of Arterial and Venous Thrombosis

Interventions

SAD, SHR-2004DRUG

Ascending dose

SAD, SHR-2004 placeboDRUG

Ascending dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Affiliated Drum Tower Hospital of Nanjing University Medical school

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

To assess the number of subjects with adverse events (AEs) and serious adverse events (SAEs)

Time frame: up to day 113

Data from ClinicalTrials.gov

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