A Phase I Study of SHR -2001 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: SHR-2001; Drug: Placebo

• Registration Number: NCT05942612
• Lead Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-04
• Study First Submitted QC: 2023-07-04
• Study First Posted: 2023-07-12
• Study Start: 2023-07-19
• Primary Completion: 2024-11-20
• Study Completion: 2024-11-20
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-20
• Last Update Posted: 2025-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	SHR-2001	A single subcutaneous injection of SHR-2001/placebo dose 1 in healthy subjects.
Cohort 1	Placebo	A single subcutaneous injection of SHR-2001/placebo dose 1 in healthy subjects.
Cohort 2	SHR-2001	A single subcutaneous injection of SHR-2001/placebo dose 2 in healthy subjects.
Cohort 2	Placebo	A single subcutaneous injection of SHR-2001/placebo dose 2 in healthy subjects.
Cohort 3	SHR-2001	A single subcutaneous injection of SHR-2001/placebo dose 3 in healthy subjects.
Cohort 3	Placebo	A single subcutaneous injection of SHR-2001/placebo dose 3 in healthy subjects.
Cohort 4	SHR-2001	A single subcutaneous injection of SHR-2001/placebo dose 4 in healthy subjects.
Cohort 4	Placebo	A single subcutaneous injection of SHR-2001/placebo dose 4 in healthy subjects.
Cohort 5	SHR-2001	A single subcutaneous injection of SHR-2001/placebo dose 5 in healthy subjects.
Cohort 5	Placebo	A single subcutaneous injection of SHR-2001/placebo dose 5 in healthy subjects.
Cohort 6	SHR-2001	A single subcutaneous injection of SHR-2001/placebo dose 6 in healthy subjects.
Cohort 6	Placebo	A single subcutaneous injection of SHR-2001/placebo dose 6 in healthy subjects.
Cohort 7	SHR-2001	A single subcutaneous injection of SHR-2001/placebo dose 7 in healthy subjects.
Cohort 7	Placebo	A single subcutaneous injection of SHR-2001/placebo dose 7 in healthy subjects.
Cohort 8	SHR-2001	A single subcutaneous injection of SHR-2001 / placebo dose 8 in healthy subjects.
Cohort 8	Placebo	A single subcutaneous injection of SHR-2001 / placebo dose 8 in healthy subjects.
Cohort 9	SHR-2001	A single subcutaneous injection of SHR-2001 / placebo dose 9 in healthy subjects.
Cohort 9	Placebo	A single subcutaneous injection of SHR-2001 / placebo dose 9 in healthy subjects.
Cohort 10	SHR-2001	A single subcutaneous injection of SHR-2001 / placebo dose 10 in healthy subjects.
Cohort 10	Placebo	A single subcutaneous injection of SHR-2001 / placebo dose 10 in healthy subjects.
Cohort 11	SHR-2001	A multiple subcutaneous injection of SHR-2001 / placebo dose 11 in healthy subjects.
Cohort 11	Placebo	A multiple subcutaneous injection of SHR-2001 / placebo dose 11 in healthy subjects.
Cohort 12	SHR-2001	A multiple subcutaneous injection of SHR-2001 / placebo dose 12 in healthy subjects.
Cohort 12	Placebo	A multiple subcutaneous injection of SHR-2001 / placebo dose 12 in healthy subjects.

Primary Outcome Measures

Name	Time	Method
Adverse events	Start of Treatment to end of study (approximately 64 days).	Incidence and severity of adverse events

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Affiliated Hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China