NCT05369767Active, not recruitingPhase 1
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
Beijing Suncadia Pharmaceuticals Co., Ltd1 site in 1 country64 target enrollmentStarted: May 24, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- To assess the number of subjects with adverse events (AEs) and serious adverse events (SAEs)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
SAD, SHR-2004
Experimental
Up to 6 cohorts of healthy subjects will receive a single dose of SHR-2004 injection
Intervention: SAD, SHR-2004 (Drug)
SAD, SHR-2004 placebo
Placebo Comparator
Up to 6 cohorts of healthy subjects will receive a single dose of SHR-2004 placebo injection
Intervention: SAD, SHR-2004 placebo (Drug)
Outcomes
Primary Outcomes
To assess the number of subjects with adverse events (AEs) and serious adverse events (SAEs)
Time Frame: up to day 113
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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