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

August 11, 2025 updated by: Guangdong Hengrui Pharmaceutical Co., Ltd

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200080
        • Shanghai General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Subjects with ability to understand the trial procedures and possible adverse events, voluntary participation in the trial.
  2. Subjects who can provide written informed consent.
  3. Males or females aged 18-55 years (both inclusive).
  4. Males with body weight ≥ 50 kg, or females with body weight ≥ 45 kg.
  5. No clinically significant abnormalities in the medical history, general physical examinations, vital signs and laboratory tests.

Exclusion Criteria:

  1. Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening.
  2. Known or suspected history of drug abuse.
  3. Addiction to tobacco and alcohol.
  4. Individuals who are unable to adhere to the dietary requirements of this trial during the study period.
  5. Judged by the investigator, there are any other conditions that interfere with the results evaluation of the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SHR-3045 Group
Drug: SHR-3045 Injection
SHR-3045 injection.
Placebo Comparator: SHR-3045 Placebo Group
Drug: SHR-3045 Placebo Injection
SHR-3045 placebo injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events (AEs)
Time Frame: From screening period up to day 113.
From screening period up to day 113.

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the concentration-time curve from time 0 to the last time point after SHR-3045 administration (AUC0-last).
Time Frame: Post-dose at day 1 to day 113.
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).
Time Frame: Post-dose at day 1 to day 113.
Post-dose at day 1 to day 113.
Maximum observed concentration of SHR-3045 (Cmax).
Time Frame: Post-dose at day 1 to day 113.
Post-dose at day 1 to day 113.
Time to maximum observed concentration of SHR-3045 (Tmax).
Time Frame: Post-dose at day 1 to day 113.
Post-dose at day 1 to day 113.
Clearance of SHR-3045 (CL).
Time Frame: Post-dose at day 1 to day 113.
Post-dose at day 1 to day 113.
Terminal elimination half-life of SHR-3045 (t1/2).
Time Frame: Post-dose at day 1 to day 113.
Post-dose at day 1 to day 113.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2025

Primary Completion (Actual)

June 17, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

March 13, 2025

First Submitted That Met QC Criteria

March 13, 2025

First Posted (Actual)

March 19, 2025

Study Record Updates

Last Update Posted (Actual)

August 12, 2025

Last Update Submitted That Met QC Criteria

August 11, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-3045-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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