A Phase I Study of SHR -2001 in Healthy Subjects

NCT05942612 | Completed Phase 1

• 1 other identifier: SHR-2001-101
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Incidence and severity of adverse events

  Start of Treatment to end of study (approximately 64 days).

Secondary Outcomes (8)

• Pharmacokinetics-AUC0-t

  Start of Treatment to end of study (approximately 64 days).

• Pharmacokinetics-AUC0-inf

  Start of Treatment to end of study (approximately 64 days).

• Pharmacokinetics-Cmax

  Start of Treatment to end of study (approximately 64 days).

• Pharmacokinetics-Tmax

  Start of Treatment to end of study (approximately 64 days).

• Pharmacokinetics-t1/2

  Start of Treatment to end of study (approximately 64 days).

Study Arms (12)

Cohort 1

EXPERIMENTAL

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

Drug: SHR-2001; Drug: Placebo

Cohort 2

EXPERIMENTAL

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

Drug: SHR-2001; Drug: Placebo

Cohort 3

EXPERIMENTAL

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

Drug: SHR-2001; Drug: Placebo

Cohort 4

EXPERIMENTAL

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

Drug: SHR-2001; Drug: Placebo

Cohort 5

EXPERIMENTAL

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

Drug: SHR-2001; Drug: Placebo

Cohort 6

EXPERIMENTAL

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

Drug: SHR-2001; Drug: Placebo

Cohort 7

EXPERIMENTAL

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

Drug: SHR-2001; Drug: Placebo

Cohort 8

EXPERIMENTAL

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

Drug: SHR-2001; Drug: Placebo

Cohort 9

EXPERIMENTAL

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

Drug: SHR-2001; Drug: Placebo

Cohort 10

EXPERIMENTAL

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

Drug: SHR-2001; Drug: Placebo

Cohort 11

EXPERIMENTAL

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

Drug: SHR-2001; Drug: Placebo

Cohort 12

EXPERIMENTAL

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

Drug: SHR-2001; Drug: Placebo

Interventions

SHR-2001 DRUG

Subcutaneous injection, single dose or multiple doses.

Cohort 1; Cohort 10; Cohort 11; Cohort 12; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7; Cohort 8; Cohort 9

Placebo DRUG

Subcutaneous injection, single dose or multiple doses.

Cohort 1; Cohort 10; Cohort 11; Cohort 12; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7; Cohort 8; Cohort 9

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Guangdong Hengrui Pharmaceutical Co., Ltd: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 12, 2023
• Study Start: July 19, 2023
• Primary Completion: November 20, 2024
• Study Completion: November 20, 2024
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

CN (1)