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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-24

Study Completion Date

2023-01-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Prevention of Arterial and Venous Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

SHR-2004 injection compared with placebo

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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SAD, SHR-2004

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

Group Type EXPERIMENTAL

SAD, SHR-2004

Intervention Type DRUG

Ascending dose

SAD, SHR-2004 placebo

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

Group Type PLACEBO_COMPARATOR

SAD, SHR-2004 placebo

Intervention Type DRUG

Ascending dose

Interventions

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SAD, SHR-2004

Ascending dose

Intervention Type DRUG

SAD, SHR-2004 placebo

Ascending dose

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes