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NCT06883695CompletedPhase 1

A Phase Ⅰ Clinical Trial to Evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of SHR-3045 in Healthy Subjects

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

Source: ClinicalTrials.gov · Last updated 5 Jun 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-3045 in healthy subjects.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
40 (actual)
First submitted
13 Mar 2025
Start date
8 Apr 2025
Primary completion date
17 Jun 2025
Lead sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd
NCT number
NCT06883695

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 40
  • From 8 Apr 2025 to the primary completion date, 17 Jun 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening.

Other illness

  • Known or suspected history of drug abuse.
  • Judged by the investigator, there are any other conditions that interfere with the results evaluation of the trial.

Other

  • Addiction to tobacco and alcohol.
  • Individuals who are unable to adhere to the dietary requirements of this trial during the study period.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shanghai General Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.