NCT06883695CompletedPhase 1
A Phase Ⅰ, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-3045 in Healthy Subjects
Guangdong Hengrui Pharmaceutical Co., Ltd1 site in 1 country40 target enrollmentStarted: April 8, 2025Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Adverse events (AEs)
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-3045 in healthy subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subjects with ability to understand the trial procedures and possible adverse events, voluntary participation in the trial.
- •Subjects who can provide written informed consent.
- •Males or females aged 18-55 years (both inclusive).
- •Males with body weight ≥ 50 kg, or females with body weight ≥ 45 kg.
- •No clinically significant abnormalities in the medical history, general physical examinations, vital signs and laboratory tests.
Exclusion Criteria
- •Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening.
- •Known or suspected history of drug abuse.
- •Addiction to tobacco and alcohol.
- •Individuals who are unable to adhere to the dietary requirements of this trial during the study period.
- •Judged by the investigator, there are any other conditions that interfere with the results evaluation of the trial.
Arms & Interventions
SHR-3045 Placebo Group
Placebo Comparator
Intervention: SHR-3045 Placebo Injection (Drug)
SHR-3045 Group
Experimental
Intervention: SHR-3045 Injection (Drug)
Outcomes
Primary Outcomes
Adverse events (AEs)
Time Frame: From screening period up to day 113.
Secondary Outcomes
- Area under the concentration-time curve from time 0 to the last time point after SHR-3045 administration (AUC0-last).(Post-dose at day 1 to day 113.)
- Area under the concentration-time curve from time 0 to infinity after SHR-3045 administration (AUC0-inf).(Post-dose at day 1 to day 113.)
- Maximum observed concentration of SHR-3045 (Cmax).(Post-dose at day 1 to day 113.)
- Time to maximum observed concentration of SHR-3045 (Tmax).(Post-dose at day 1 to day 113.)
- Clearance of SHR-3045 (CL).(Post-dose at day 1 to day 113.)
- Terminal elimination half-life of SHR-3045 (t1/2).(Post-dose at day 1 to day 113.)
Investigators
Study Sites (1)
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