A Phase I Study of SHR -2001 in Healthy Subjects

Sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05942612

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study is a phase 1 single dose 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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: SHR-2001 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 20, 2023

Anticipated Primary Completion Date :

Dec 20, 2023

Anticipated Study Completion Date :

Dec 20, 2023

Arms and Interventions

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 Drug: Placebo Subcutaneous injection, single dose
Experimental: Cohort 2 A single subcutaneous injection of SHR-2001/placebo dose 2 in healthy subjects	Drug: SHR-2001 Subcutaneous injection, single dose Drug: Placebo Subcutaneous injection, single dose
Experimental: Cohort 3 A single subcutaneous injection of SHR-2001/placebo dose 3 in healthy subjects	Drug: SHR-2001 Subcutaneous injection, single dose Drug: Placebo Subcutaneous injection, single dose
Experimental: Cohort 4 A single subcutaneous injection of SHR-2001/placebo dose 4 in healthy subjects	Drug: SHR-2001 Subcutaneous injection, single dose Drug: Placebo Subcutaneous injection, single dose
Experimental: Cohort 5 A single subcutaneous injection of SHR-2001/placebo dose 5 in healthy subjects	Drug: SHR-2001 Subcutaneous injection, single dose Drug: Placebo Subcutaneous injection, single dose
Experimental: Cohort 6 A single subcutaneous injection of SHR-2001/placebo dose 6 in healthy subjects	Drug: SHR-2001 Subcutaneous injection, single dose Drug: Placebo Subcutaneous injection, single dose
Experimental: Experimental: Cohort 7 A single subcutaneous injection of SHR-2001/placebo dose 7 in healthy subjects	Drug: SHR-2001 Subcutaneous injection, single dose Drug: Placebo Subcutaneous injection, single dose

Outcome Measures

Primary Outcome Measures

Adverse events [Start of Treatment to end of study (approximately 50 days)]
Incidence and severity of adverse events

Secondary Outcome Measures

Pharmacokinetics-AUC0-t: [Start of Treatment to end of study (approximately 50 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 50 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 50 days)]
Maximum observed concentration of SHR-2001
Pharmacokinetics-Tmax： [Start of Treatment to end of study (approximately 50 days)]
Time to Cmax
Pharmacokinetics-t1/2： [Start of Treatment to end of study (approximately 50 days)]
Terminal elimination half-life of SHR-2001
Pharmacokinetics-CL/F [Start of Treatment to end of study (approximately 50 days))]
Apparent clearance of SHR-2001
Pharmacokinetics-Vz/F [Start of Treatment to end of study (approximately 50 days))]
Apparent volume of distribution during terminal phase of SHR-2001
Anti-Drug antibody [Start of Treatment to end of study (approximately 50 days)]
The percentage of subjects with positive ADA

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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;
Age 18 ~ 55 years old (including boundary value), male or female;
Weight ≥ 45 kg, body mass index (BMI) ranging 19 ~ 28 kg/m2 (including boundary value);
Participants who are overtly healthy as determined by medical history and physical examination.;
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:

Those who have serious systemic diseases within 3 months before screening or administration, and the investigator believes that there may be safety risks;
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;
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;

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Guangdong Hengrui Pharmaceutical Co., Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Guangdong Hengrui Pharmaceutical Co., Ltd

ClinicalTrials.gov Identifier:

NCT05942612

Other Study ID Numbers:

SHR-2001-101

First Posted:

Jul 12, 2023

Last Update Posted:

Jul 12, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 12, 2023