A Trial of SHR-1905 in Healthy Subjects and Subjects With Mild Asthma

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Administered SHR-1905 in Healthy Subjects and Subjects With Mild Asthma.

This study is a phase 1 single dose escalation study of SHR-1905 in healthy subjects and subjects with mild asthma. The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of SHR-1905 in healthy subjects and subjects with mild asthma.

Study Overview

• Status: Recruiting
• Conditions: Asthma
• Intervention / Treatment: Drug: SHR-1905/placebo

• Study Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Xiaoyu Yang; Phone Number: +86 18818211895; Email: xiaoyu.yang@hengrui.com
• Study Contact Backup: Name: Bo zhu; Phone Number: +86 13380043088; Email: bo.zhu@hengrui.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200031
      • Recruiting
      • Shanghai Xuhui Central Hospital
      • Contact: Chen Yu, Bachelor; Phone Number: 86-21-54030254; Email: cyu@shxh-centerlab.com

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, body mass index (BMI) between 18 and 28 kg/m2 at screening.
4. For healthy subjects, 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.

Exclusion Criteria:

1. Known medical history of severe disease in cardiovascular, liver, kidney, digestive tract, mental, nerve, hematology, metabolic disorders, etc.
2. Severe injuries or major surgeries within 6 months before screening or plan to do surgeries during the trial.
3. Positive hepatitis B virus (HBsAg), hepatitis C virus (HCV-Ab), human immunodeficiency virus (HIV-Ab) at screening.
4. Hyper/Hypotension which define as Systolic blood pressure (SBP) >140mmHg or <90mmHg, or Diastolic blood pressure (DBP)>90mmHg or <40mmHg at screening and at check in.
5. Clinically significant abnormalities in 12-Lead ECG (e.g., For male QTcF > 450msec, for female QTcF > 470msec) at screening and at check in
6. Positive alcohol breath test during baseline visit.
7. Positive nicotine test during screening.
8. Positive urine drug screen during screening.
9. 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 have consented and used other investigational drugs (including placebo) or trial medical devices
10. Any other circumstances that, in the investigator's judgment, may increase the risk to the subject, or associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cohort 1; A single subcutaneous injection of SHR-1905/placebo dose 1 in healthy subjects	Drug: SHR-1905/placebo; Drug: SHR-1905 subcutaneous, single dose Drug: Placebo subcutaneous, single dose
EXPERIMENTAL: Cohort 2; A single subcutaneous injection of SHR-1905/placebo dose 2 in healthy subjects	Drug: SHR-1905/placebo; Drug: SHR-1905 subcutaneous, single dose Drug: Placebo subcutaneous, single dose
EXPERIMENTAL: Cohort 3; A single subcutaneous injection of SHR-1905/placebo dose 3 in healthy subjects	Drug: SHR-1905/placebo; Drug: SHR-1905 subcutaneous, single dose Drug: Placebo subcutaneous, single dose
EXPERIMENTAL: Cohort 4; A single subcutaneous injection of SHR-1905/placebo dose 4 in healthy subjects	Drug: SHR-1905/placebo; Drug: SHR-1905 subcutaneous, single dose Drug: Placebo subcutaneous, single dose
EXPERIMENTAL: Cohort 5; A single subcutaneous injection of SHR-1905/placebo dose 5 in healthy subjects	Drug: SHR-1905/placebo; Drug: SHR-1905 subcutaneous, single dose Drug: Placebo subcutaneous, single dose
EXPERIMENTAL: Cohort 6; A single subcutaneous injection of SHR-1905/placebo dose 6 in subjects with mild asthma	Drug: SHR-1905/placebo; Drug: SHR-1905 subcutaneous, single dose Drug: Placebo subcutaneous, 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 16 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-1905 administration	Start of Treatment to end of study (approximately 16 weeks)
Pharmacokinetics-AUC0-inf	Area under the concentration-time curve from time 0 to infinity after SHR-1905 administration	Start of Treatment to end of study (approximately 16 weeks)
Pharmacokinetics-Tmax	Time to Cmax of SHR-1905	Start of Treatment to end of study (approximately 16 weeks)
Pharmacokinetics-Cmax	Maximum observed concentration of SHR-1905	Start of Treatment to end of study (approximately 16 weeks)
Pharmacokinetics-CL/F	Apparent clearance of SHR-1905	Start of Treatment to end of study (approximately 16 weeks)
Pharmacokinetics-t1/2	Terminal elimination half-life of SHR-1905	Start of Treatment to end of study (approximately 16 weeks)
Anti-Drug antibody	The percentage of subjects with positive ADA titers over time for SHR-1905	Start of Treatment to end of study (approximately 16 weeks)
Pharmacokinetics-V/F	Apparent volume of distribution during terminal phase of SHR-1905	Start of Treament to end of study (approximately 16 weeks)

Collaborators and Investigators

• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 15, 2021
• Primary Completion (ANTICIPATED): January 13, 2022
• Study Completion (ANTICIPATED): January 13, 2022

Study Registration Dates

• First Submitted: May 26, 2021
• First Submitted That Met QC Criteria: May 26, 2021
• First Posted (ACTUAL): May 27, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 11, 2021
• Last Update Submitted That Met QC Criteria: October 8, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: SHR-1905-101

Drug and device information, study documents

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