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

A Phase 1, Randomized, Double Blind, Dose-escalation, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2004 in Healthy Subjects

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05369767

Enrollment

Registered

2022-05-11

Start date

2022-05-24

Completion date

2023-01-30

Last updated

2022-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of Arterial and Venous Thrombosis

Brief summary

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.

Interventions

DRUGSAD, SHR-2004

Ascending dose

DRUGSAD, SHR-2004 placebo

Ascending dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

TRIPLE (Subject, Caregiver, Investigator)

Intervention model description

SHR-2004 injection compared with placebo

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
To assess the number of subjects with adverse events (AEs) and serious adverse events (SAEs)	up to day 113

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026