Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single-dose Injection of SHR-2004 in Healthy Subjects
Primary Purpose
Prevention of Arterial and Venous Thrombosis
Status
Active
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SAD, SHR-2004
SAD, SHR-2004 placebo
Sponsored by
About this trial
This is an interventional other trial for Prevention of Arterial and Venous Thrombosis
Eligibility Criteria
Inclusion Criteria:
- males or females, aged 18-55;
- 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:
- previous medical history of coagulation or bleeding disorders;
- known risks of bleeding or thrombosis, such as recurrent gingival bleeding, spontaneous bleeding, haemorrhoids, gastrointestinal ulcers, or other high-risk bleeding diseases.
Sites / Locations
- Affiliated Drum Tower Hospital of Nanjing University Medical school
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SAD, SHR-2004
SAD, SHR-2004 placebo
Arm Description
Up to 6 cohorts of healthy subjects will receive a single dose of SHR-2004 injection
Up to 6 cohorts of healthy subjects will receive a single dose of SHR-2004 placebo injection
Outcomes
Primary Outcome Measures
To assess the number of subjects with adverse events (AEs) and serious adverse events (SAEs)
Secondary Outcome Measures
Full Information
NCT ID
NCT05369767
First Posted
May 6, 2022
Last Updated
November 29, 2022
Sponsor
Beijing Suncadia Pharmaceuticals Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05369767
Brief Title
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single-dose Injection of SHR-2004 in Healthy Subjects
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 24, 2022 (Actual)
Primary Completion Date
January 30, 2023 (Anticipated)
Study Completion Date
January 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Suncadia Pharmaceuticals Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention of Arterial and Venous Thrombosis
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
SHR-2004 injection compared with placebo
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SAD, SHR-2004
Arm Type
Experimental
Arm Description
Up to 6 cohorts of healthy subjects will receive a single dose of SHR-2004 injection
Arm Title
SAD, SHR-2004 placebo
Arm Type
Placebo Comparator
Arm Description
Up to 6 cohorts of healthy subjects will receive a single dose of SHR-2004 placebo injection
Intervention Type
Drug
Intervention Name(s)
SAD, SHR-2004
Intervention Description
Ascending dose
Intervention Type
Drug
Intervention Name(s)
SAD, SHR-2004 placebo
Intervention Description
Ascending dose
Primary Outcome Measure Information:
Title
To assess the number of subjects with adverse events (AEs) and serious adverse events (SAEs)
Time Frame
up to day 113
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
males or females, aged 18-55;
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:
previous medical history of coagulation or bleeding disorders;
known risks of bleeding or thrombosis, such as recurrent gingival bleeding, spontaneous bleeding, haemorrhoids, gastrointestinal ulcers, or other high-risk bleeding diseases.
Facility Information:
Facility Name
Affiliated Drum Tower Hospital of Nanjing University Medical school
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single-dose Injection of SHR-2004 in Healthy Subjects
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