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Clinical Trials/NCT06883695
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

Sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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