A Phase I Study of SHR -2001 in Healthy Subjects

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2001 After a Single or Multiple Subcutaneous Injections in Healthy Subjects

This study is a phase 1 single dose or multiple doses escalation study of SHR-2001 in healthy subjects. The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-2001 in healthy subjects.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: SHR-2001; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266000
      • The Affiliated Hospital of Qingdao University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Obtain informed consent from participants before the start of any study related activities. Participants must have a full understanding of the purpose and significance of the trial, and be willing to comply with the trial protocol;
2. Age 18 ~ 55 years old (including boundary value), male or female;
3. Weight ≥ 45 kg, body mass index (BMI) ranging 19 ~ 28 kg/m2 (including boundary value);
4. Participants who are overtly healthy as determined by medical history and physical examination.;
5. Participants and their partners have no fertility plan and voluntarily use highly effective contraception. Female subjects must have a negative serum pregnancy test and be non-lactating.

Exclusion Criteria:

1. Those who have serious systemic diseases within 3 months before screening or administration, and the investigator believes that there may be safety risks;
2. Those who have serious infection, severe trauma or major surgery within 6 months before screening or administration; those who plan to undergo surgery during the trial;
3. Inactivated vaccine received within 2 weeks prior to randomization or live attenuated vaccine within 3 months prior to randomization, or intended to be vaccinated during the study period;

Study Plan

How is the study designed?

Design Details

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

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; A single subcutaneous injection of SHR-2001/placebo dose 1 in healthy subjects.	Drug: SHR-2001; Subcutaneous injection, single dose or multiple doses.; Drug: Placebo; Subcutaneous injection, single dose or multiple doses.
Experimental: Cohort 2; A single subcutaneous injection of SHR-2001/placebo dose 2 in healthy subjects.	Drug: SHR-2001; Subcutaneous injection, single dose or multiple doses.; Drug: Placebo; Subcutaneous injection, single dose or multiple doses.
Experimental: Cohort 3; A single subcutaneous injection of SHR-2001/placebo dose 3 in healthy subjects.	Drug: SHR-2001; Subcutaneous injection, single dose or multiple doses.; Drug: Placebo; Subcutaneous injection, single dose or multiple doses.
Experimental: Cohort 4; A single subcutaneous injection of SHR-2001/placebo dose 4 in healthy subjects.	Drug: SHR-2001; Subcutaneous injection, single dose or multiple doses.; Drug: Placebo; Subcutaneous injection, single dose or multiple doses.
Experimental: Cohort 5; A single subcutaneous injection of SHR-2001/placebo dose 5 in healthy subjects.	Drug: SHR-2001; Subcutaneous injection, single dose or multiple doses.; Drug: Placebo; Subcutaneous injection, single dose or multiple doses.
Experimental: Cohort 6; A single subcutaneous injection of SHR-2001/placebo dose 6 in healthy subjects.	Drug: SHR-2001; Subcutaneous injection, single dose or multiple doses.; Drug: Placebo; Subcutaneous injection, single dose or multiple doses.
Experimental: Cohort 7; A single subcutaneous injection of SHR-2001/placebo dose 7 in healthy subjects.	Drug: SHR-2001; Subcutaneous injection, single dose or multiple doses.; Drug: Placebo; Subcutaneous injection, single dose or multiple doses.
Experimental: Cohort 8; A single subcutaneous injection of SHR-2001 / placebo dose 8 in healthy subjects.	Drug: SHR-2001; Subcutaneous injection, single dose or multiple doses.; Drug: Placebo; Subcutaneous injection, single dose or multiple doses.
Experimental: Cohort 9; A single subcutaneous injection of SHR-2001 / placebo dose 9 in healthy subjects.	Drug: SHR-2001; Subcutaneous injection, single dose or multiple doses.; Drug: Placebo; Subcutaneous injection, single dose or multiple doses.
Experimental: Cohort 10; A single subcutaneous injection of SHR-2001 / placebo dose 10 in healthy subjects.	Drug: SHR-2001; Subcutaneous injection, single dose or multiple doses.; Drug: Placebo; Subcutaneous injection, single dose or multiple doses.
Experimental: Cohort 11; A multiple subcutaneous injection of SHR-2001 / placebo dose 11 in healthy subjects.	Drug: SHR-2001; Subcutaneous injection, single dose or multiple doses.; Drug: Placebo; Subcutaneous injection, single dose or multiple doses.
Experimental: Cohort 12; A multiple subcutaneous injection of SHR-2001 / placebo dose 12 in healthy subjects.	Drug: SHR-2001; Subcutaneous injection, single dose or multiple doses.; Drug: Placebo; Subcutaneous injection, single dose or multiple doses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Incidence and severity of adverse events	Start of Treatment to end of study (approximately 64 days).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics-AUC0-t	Area under the concentration-time curve from 0 to the last measurable time point after SHR-2001 administration	Start of Treatment to end of study (approximately 64 days).
Pharmacokinetics-AUC0-inf	Area under the concentration-time curve from time 0 to infinity after SHR-2001 administration	Start of Treatment to end of study (approximately 64 days).
Pharmacokinetics-Cmax	Maximum observed concentration of SHR-2001	Start of Treatment to end of study (approximately 64 days).
Pharmacokinetics-Tmax	Time to Cmax	Start of Treatment to end of study (approximately 64 days).
Pharmacokinetics-t1/2	Terminal elimination half-life of SHR-2001	Start of Treatment to end of study (approximately 64 days).
Pharmacokinetics-CL/F	Apparent clearance of SHR-2001	Start of Treatment to end of study (approximately 64 days).
Pharmacokinetics-Vz/F	Apparent volume of distribution during terminal phase of SHR-2001	Start of Treatment to end of study (approximately 64 days).
Anti-Drug antibody	The percentage of subjects with positive ADA	Start of Treatment to end of study (approximately 64 days).

Collaborators and Investigators

• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2023
• Primary Completion (Actual): November 20, 2024
• Study Completion (Actual): November 20, 2024

Study Registration Dates

• First Submitted: July 4, 2023
• First Submitted That Met QC Criteria: July 4, 2023
• First Posted (Actual): July 12, 2023

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 20, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: SHR-2001-101

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