A Trial of SHR - 1906 in Healthy Subjects

NCT04986540 | Completed Phase 1

• 1 other identifier: SHR-1906-101
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Incidence and severity of adverse events

  Start of Treatment to end of study (approximately 10 weeks)

Secondary Outcomes (8)

• Pharmacokinetics-AUC0-last

  Start of Treatment to end of study (approximately 10 weeks)

• Pharmacokinetics-AUC0-inf

  Start of Treatment to end of study (approximately 10 weeks)

• Pharmacokinetics-Tmax

  Start of Treatment to end of study (approximately 10 weeks)

• Pharmacokinetics-Cmax

  Start of Treatment to end of study (approximately 10 weeks)

• Pharmacokinetics-CL

  Start of Treatment to end of study (approximately 10 weeks)

Study Arms (6)

Cohort 1

EXPERIMENTAL

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

Drug: SHR-1906；Placebo

Cohort 2

EXPERIMENTAL

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

Drug: SHR-1906；Placebo

Cohort 3

EXPERIMENTAL

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

Drug: SHR-1906；Placebo

Cohort 4

EXPERIMENTAL

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

Drug: SHR-1906；Placebo

Cohort 5

EXPERIMENTAL

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

Drug: SHR-1906；Placebo

Cohort 6

EXPERIMENTAL

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

Drug: SHR-1906；Placebo

Interventions

SHR-1906；Placebo DRUG

Drug: SHR-1906 IV, single dose Drug: Placebo IV, single dose

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6

Eligibility Criteria

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

You may qualify if:

• 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.
• Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
• Total body weight ≥ 45 kg.
• 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
• Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods

You may not qualify if:

• History of serious cardiovascular, liver, kidney, digestive tract, psychiatric, hematology, metabolic disorders, primary immunodeficiency disease or acquired immune deficiency syndrome, or organ transplantation.
• 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.
• Positive testing for human immunodeficiency virus (HIV-Ab), or hepatitis B surface antigen (HBsAg), or TP-Ab , or hepatitis C antibodies (HCV-Ab).
• Screening/baseline systolic blood pressure (BP) ≥140 mmHg or ≤90 mmHg; diastolic BP ≥90 mmHg or \<60 mmHg on a single measurement
• Positive urine drug screening at baseline;
• 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.
• 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.
• Blood donation or loss of ≥ 400 mL of blood within 1 months; or received blood or blood products within 2 months prior to screening.
• 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.
• Researchers and relevant staff of the research center or other persons directly involved in the implementation of the program.

Sponsors & Collaborators

• Guangdong Hengrui Pharmaceutical Co., Ltd: lead

Study Sites (1)

Phase I Clinical Research Unit, Qianfoshan Hospital of Shandong Province

Jinan, Shandong, 250014, China

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

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

Model Details: SHR-1906 compared with placebo

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 3, 2021
• Study Start: August 10, 2021
• Primary Completion: September 7, 2022
• Study Completion: September 7, 2022
• Last Updated: February 16, 2023

Record last verified: 2023-02

Locations

CN (1)