A Trial of SHR - 1906 in Healthy Subjects

NCT ID: NCT04986540

Last Updated: 2023-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-10
• Study Completion Date: 2022-09-07

Brief Summary

This study is a phase 1 single dose escalation study of SHR-1906 in healthy subjects. The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of SHR-1906 in healthy subjects.

Conditions

Idiopathic Pulmonary Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cohort 1

A single subcutaneous injection of SHR-1906/placebo dose 1 in healthy subjects

Group Type: EXPERIMENTAL

SHR-1906；Placebo

Intervention Type: DRUG

Drug: SHR-1906 IV, single dose

Drug: Placebo IV, single dose

Cohort 2

A single subcutaneous injection of SHR-1906/placebo dose 2 in healthy subjects

Group Type: EXPERIMENTAL

SHR-1906；Placebo

Intervention Type: DRUG

Drug: SHR-1906 IV, single dose

Drug: Placebo IV, single dose

Cohort 3

A single subcutaneous injection of SHR-1906/placebo dose 3 in healthy subjects

Group Type: EXPERIMENTAL

SHR-1906；Placebo

Intervention Type: DRUG

Drug: SHR-1906 IV, single dose

Drug: Placebo IV, single dose

Cohort 4

A single subcutaneous injection of SHR-1906/placebo dose 4 in healthy subjects

Group Type: EXPERIMENTAL

SHR-1906；Placebo

Intervention Type: DRUG

Drug: SHR-1906 IV, single dose

Drug: Placebo IV, single dose

Cohort 5

A single subcutaneous injection of SHR-1906/placebo dose 5 in healthy subjects

Group Type: EXPERIMENTAL

SHR-1906；Placebo

Intervention Type: DRUG

Drug: SHR-1906 IV, single dose

Drug: Placebo IV, single dose

Cohort 6

A single subcutaneous injection of SHR-1906/placebo dose 6 in healthy subjects

Group Type: EXPERIMENTAL

SHR-1906；Placebo

Intervention Type: DRUG

Drug: SHR-1906 IV, single dose

Drug: Placebo IV, single dose

Interventions

SHR-1906；Placebo

Drug: SHR-1906 IV, single dose

Drug: Placebo IV, single dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial, and provides written informed consent, be able to comply with all the requirements and able to complete the study.

2. Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.

3. Total body weight ≥ 45 kg.

4. No clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests (hematology, urinalysis, blood chemistry, coagulation function and thyroid function) and ECG at the investigator's discretion during screening and baseline

5. Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods

Exclusion Criteria

1. History of serious cardiovascular, liver, kidney, digestive tract, psychiatric, hematology, metabolic disorders, primary immunodeficiency disease or acquired immune deficiency syndrome, or organ transplantation.

2. Severe infections, injuries or major surgeries (as determined by the investigator) within 6 months prior to screening, or plan to do any surgery during the trial.

3. Positive testing for human immunodeficiency virus (HIV-Ab), or hepatitis B surface antigen (HBsAg), or TP-Ab , or hepatitis C antibodies (HCV-Ab).

4. Screening/baseline systolic blood pressure (BP) ≥140 mmHg or ≤90 mmHg; diastolic BP ≥90 mmHg or <60 mmHg on a single measurement

5. Positive urine drug screening at baseline;

6. Use of any medicine within 1 monthes (including any prescription, or over-the-counter medicine, herbal remedy or nutritional supplement, except for vitamins and occasional use of acetaminophen with recommended dose), or within 5 half-lives of any drugs whichever is longer prior to dosing, or plan to use any medicine during the trial.

7. Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening or within 5 half-lives of any drugs during screening visit, or in the follow-up period of a clinical study whichever is longer (according to the date of signed consent form) which is defined as having consented and used other investigational drugs (including placebo) or trial medical devices.

8. Blood donation or loss of ≥ 400 mL of blood within 1 months; or received blood or blood products within 2 months prior to screening.

9. Any other circumstances that, in the investigator's judgment, may increase the risk associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response.

10. Researchers and relevant staff of the research center or other persons directly involved in the implementation of the program.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guangdong Hengrui Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Phase I Clinical Research Unit, Qianfoshan Hospital of Shandong Province

Jinan, Shandong, China

Countries

China

Other Identifiers

SHR-1906-101

Identifier Type: -

Identifier Source: org_study_id