A Phase I Study of SHR -2001 in Healthy Subjects

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: SHR-2001

Study type: Interventional

Funder types: Industry

Identifiers

NCT05942612

SHR-2001-101

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 12 patient groups

Cohort 1

Experimental group

Description:

A single subcutaneous injection of SHR-2001/placebo dose 1 in healthy subjects.

Treatment:

Drug: SHR-2001

Drug: Placebo

Cohort 2

Experimental group

Description:

A single subcutaneous injection of SHR-2001/placebo dose 2 in healthy subjects.

Treatment:

Drug: SHR-2001

Drug: Placebo

Cohort 3

Experimental group

Description:

A single subcutaneous injection of SHR-2001/placebo dose 3 in healthy subjects.

Treatment:

Drug: SHR-2001

Drug: Placebo

Cohort 4

Experimental group

Description:

A single subcutaneous injection of SHR-2001/placebo dose 4 in healthy subjects.

Treatment:

Drug: SHR-2001

Drug: Placebo

Cohort 5

Experimental group

Description:

A single subcutaneous injection of SHR-2001/placebo dose 5 in healthy subjects.

Treatment:

Drug: SHR-2001

Drug: Placebo

Cohort 6

Experimental group

Description:

A single subcutaneous injection of SHR-2001/placebo dose 6 in healthy subjects.

Treatment:

Drug: SHR-2001

Drug: Placebo

Cohort 7

Experimental group

Description:

A single subcutaneous injection of SHR-2001/placebo dose 7 in healthy subjects.

Treatment:

Drug: SHR-2001

Drug: Placebo

Cohort 8

Experimental group

Description:

A single subcutaneous injection of SHR-2001 / placebo dose 8 in healthy subjects.

Treatment:

Drug: SHR-2001

Drug: Placebo

Cohort 9

Experimental group

Description:

A single subcutaneous injection of SHR-2001 / placebo dose 9 in healthy subjects.

Treatment:

Drug: SHR-2001

Drug: Placebo

Cohort 10

Experimental group

Description:

A single subcutaneous injection of SHR-2001 / placebo dose 10 in healthy subjects.

Treatment:

Drug: SHR-2001

Drug: Placebo

Cohort 11

Experimental group

Description:

A multiple subcutaneous injection of SHR-2001 / placebo dose 11 in healthy subjects.

Treatment:

Drug: SHR-2001

Drug: Placebo

Cohort 12

Experimental group

Description:

A multiple subcutaneous injection of SHR-2001 / placebo dose 12 in healthy subjects.

Treatment:

Drug: SHR-2001

Drug: Placebo