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
1 other identifier
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2022
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2022
CompletedFirst Posted
Study publicly available on registry
May 11, 2022
CompletedStudy Start
First participant enrolled
May 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2023
CompletedNovember 30, 2022
November 1, 2022
8 months
May 6, 2022
November 29, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
To assess the number of subjects with adverse events (AEs) and serious adverse events (SAEs)
up to day 113
Study Arms (2)
SAD, SHR-2004
EXPERIMENTALUp to 6 cohorts of healthy subjects will receive a single dose of SHR-2004 injection
SAD, SHR-2004 placebo
PLACEBO COMPARATORUp to 6 cohorts of healthy subjects will receive a single dose of SHR-2004 placebo injection
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Affiliated Drum Tower Hospital of Nanjing University Medical school
Nanjing, Jiangsu, 210008, China
Related Publications (1)
Ma T, Weng Z, Cao B, Dong Y, Deng C, Huang L, Yang Y, Wang Y, Shen C, Wang L, Shen K, Li J. The first-in-human study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of the factor XI monoclonal antibody SHR-2004 in healthy subjects. Expert Opin Investig Drugs. 2024 Oct;33(10):1075-1082. doi: 10.1080/13543784.2024.2391837. Epub 2024 Aug 22.
PMID: 39166425DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2022
First Posted
May 11, 2022
Study Start
May 24, 2022
Primary Completion
January 30, 2023
Study Completion
January 30, 2023
Last Updated
November 30, 2022
Record last verified: 2022-11