A Trial of SHR - 1906 in Healthy Subjects

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single IV Infusion of SHR-1906 in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: SHR-1906；Placebo

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250014
      • Phase I Clinical Research Unit, Qianfoshan Hospital of Shandong Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; A single subcutaneous injection of SHR-1906/placebo dose 1 in healthy subjects	Drug: SHR-1906；Placebo; Drug: SHR-1906 IV, single dose Drug: Placebo IV, single dose
Experimental: Cohort 2; A single subcutaneous injection of SHR-1906/placebo dose 2 in healthy subjects	Drug: SHR-1906；Placebo; Drug: SHR-1906 IV, single dose Drug: Placebo IV, single dose
Experimental: Cohort 3; A single subcutaneous injection of SHR-1906/placebo dose 3 in healthy subjects	Drug: SHR-1906；Placebo; Drug: SHR-1906 IV, single dose Drug: Placebo IV, single dose
Experimental: Cohort 4; A single subcutaneous injection of SHR-1906/placebo dose 4 in healthy subjects	Drug: SHR-1906；Placebo; Drug: SHR-1906 IV, single dose Drug: Placebo IV, single dose
Experimental: Cohort 5; A single subcutaneous injection of SHR-1906/placebo dose 5 in healthy subjects	Drug: SHR-1906；Placebo; Drug: SHR-1906 IV, single dose Drug: Placebo IV, single dose
Experimental: Cohort 6; A single subcutaneous injection of SHR-1906/placebo dose 6 in healthy subjects	Drug: SHR-1906；Placebo; Drug: SHR-1906 IV, single dose Drug: Placebo IV, single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Incidence and severity of adverse events	Start of Treatment to end of study (approximately 10 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics-AUC0-last	Area under the concentration-time curve from time 0 to last time point after SHR-1906 administration	Start of Treatment to end of study (approximately 10 weeks)
Pharmacokinetics-AUC0-inf	Area under the concentration-time curve from time 0 to infinity after SHR-1906 administration	Start of Treatment to end of study (approximately 10 weeks)
Pharmacokinetics-Tmax	Time to Cmax of SHR-1906	Start of Treatment to end of study (approximately 10 weeks)
Pharmacokinetics-Cmax	Maximum observed concentration of SHR-1906	Start of Treatment to end of study (approximately 10 weeks)
Pharmacokinetics-CL	Clearance of SHR-1906	Start of Treatment to end of study (approximately 10 weeks)
Pharmacokinetics-V	Volume of distribution during terminal phase of SHR-1906	Start of Treatment to end of study (approximately 10 weeks)
Pharmacokinetics-t1/2	Terminal elimination half-life of SHR-1906	Start of Treatment to end of study (approximately 10 weeks)
Anti-Drug antibody	The percentage of subjects with positive ADA titers over time for SHR-1906	Start of Treatment to end of study (approximately 10 weeks)

Collaborators and Investigators

• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2021
• Primary Completion (Actual): September 7, 2022
• Study Completion (Actual): September 7, 2022

Study Registration Dates

• First Submitted: July 27, 2021
• First Submitted That Met QC Criteria: July 27, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Actual): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: SHR-1906-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No