A Phase I Study of SHR -2001 in Healthy Subjects

Healthy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05942612
• Other study ID #: SHR-2001-101
• Status: Recruiting
• Phase: Phase 1
• Start date: July 18, 2023
• Est. completion date: December 20, 2023

Study information

• Verified date: May 2023
• Source: Guangdong Hengrui Pharmaceutical Co., Ltd
• Contact: Ye Xu
• Phone: 0518-82342973
• Email: ye.xu.yx1[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 49
• Est. completion date: December 20, 2023
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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;

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• SHR-2001
Subcutaneous injection, single dose
• Placebo
Subcutaneous injection, single dose

Locations

Country	Name	City	State
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Hengrui Pharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Incidence and severity of adverse events	Start of Treatment to end of study (approximately 50 days)
Secondary	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 50 days)
Secondary	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 50 days)
Secondary	Pharmacokinetics-Cmax:	Maximum observed concentration of SHR-2001	Start of Treatment to end of study (approximately 50 days)
Secondary	Pharmacokinetics-Tmax:	Time to Cmax	Start of Treatment to end of study (approximately 50 days)
Secondary	Pharmacokinetics-t1/2:	Terminal elimination half-life of SHR-2001	Start of Treatment to end of study (approximately 50 days)
Secondary	Pharmacokinetics-CL/F	Apparent clearance of SHR-2001	Start of Treatment to end of study (approximately 50 days))
Secondary	Pharmacokinetics-Vz/F	Apparent volume of distribution during terminal phase of SHR-2001	Start of Treatment to end of study (approximately 50 days))
Secondary	Anti-Drug antibody	The percentage of subjects with positive ADA	Start of Treatment to end of study (approximately 50 days)