A Trial of SHR-1703 in Healthy Adults

November 10, 2022 updated by: Jiangsu HengRui Medicine Co., Ltd.

A Randomised, Double Blind, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-1703 Injection Administered Subcutaneously in Healthy Subjects

SHR-1703 is a monoclonal antibody under development for severe asthma. This study is the first study in Healthy subjects. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose SHR-1703 administered subcutaneously in Chinese healthy subjects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will be conducted at 1 study center in China. Approximately 42 healthy Chinese male and female subjects, aged 18 to 55 inclusive, will be randomized to receive a single SC administration of SHR-1703: Treatment 1, Treatment 2, Treatment 3, Treatment 4 and Treatment 5. Each subject will participate in only 1 treatment group. The total length of the study for each subject is up to 190 days (28 days of screening and 155+/- 7 days of further study visits).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610044
        • West China Hospital of Sichuan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • Able to read, comprehend and write at a sufficient level to complete study materials.
  • Aged 18 to 55 years (inclusive).
  • Body weight equal or more than 45.0 kg and BMI within the range between 19 and 24kg/m2 (inclusive).
  • AST, ALT, alkaline phosphatase and bilirubin equal or less than ULN.
  • Healthy Chinese as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the Jiangsu HengRui Medicine Co Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
  • Subjects must commit to consistent and correct use of an acceptable method of birth control from the start of trial to the next month after the last visit.
  • A negative pre-study drug/alcohol screen.

Exclusion Criteria:

  • Allergy/intolerance to the SHR-1703 and/or excipients in the formulation, or any other Biologics
  • Positive Hepatitis B surface antigen or positive Hepatitis C antibody or human immunodeficiency virus - HIV antibody or Syphilis serological test at screening
  • The subject has participated in a clinical trial and has received an investigational product within the following time period prior to screening in the current study: 3 months, 5 half-lives or fellow-up period of the investigational product (whichever is longer).
  • Use of any medicines, including prescription or Over-the-Counter drugs (including herbal and dietary supplements, not including regular vitamins and paracetamol which be used occasionally in the recommended dose) within 1 month or 5 half-lives (whichever is longer) prior to the administration.
  • Subjects who have received immune inhibitors within 6 months prior to screening
  • Subjects who have had severe trauma or surgery within 6 months prior to screening, or who plan to undergo surgery during the trial.
  • Blood donation history within 1 month prior to screening ,or severe blood loss(total blood volume≥400 ml)，or blood transfusion within 2 months
  • Subjects who are inoculated live (attenuated) vaccine within 1 month prior to screening or during the trial.
  • Subject who is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.
  • At the discretion of the investigator, a subject will not be eligible for this study if he/she is in the following cases: the subject is not able to complete the study, or present a significant risk to the subject, or present other factors(e.g. infirmity. etc.) that may prevent the enrolment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SHR-1703-Subcutaneous administration of Dose 1
A single subcutaneous injection of SHR-1703 (Dose 1) or Placebo
Drug: SHR-1703
SHR-1703
Drug: Placebo
Placebo of the SHR-1703
Experimental: SHR-1703-Subcutaneous administration of Dose 2
A single subcutaneous injection of SHR-1703 (Dose 2) or Placebo
Drug: SHR-1703
SHR-1703
Drug: Placebo
Placebo of the SHR-1703
Experimental: SHR-1703-Subcutaneous administration of Dose 3
A single subcutaneous injection of SHR-1703 (Dose 3) or Placebo
Drug: SHR-1703
SHR-1703
Drug: Placebo
Placebo of the SHR-1703
Experimental: SHR-1703-Subcutaneous administration of Dose 4
A single subcutaneous injection of SHR-1703 (Dose 4) or Placebo
Drug: SHR-1703
SHR-1703
Drug: Placebo
Placebo of the SHR-1703
Experimental: SHR-1703-Subcutaneous administration of Dose 5
A single subcutaneous injection of SHR-1703 (Dose 5) or Placebo
Drug: SHR-1703
SHR-1703
Drug: Placebo
Placebo of the SHR-1703

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with Adverse events (AEs) and serious adverse events (SAEs)
Time Frame: From Day 1 to Days 155
The number and percentage of subjects with treatment-emergent AE/SAE/AE by severity/drug-related AE/drug-related SAE/death in each dose level group and overall. AE/SAE will be displayed by MedDRA SOC and/or PT
From Day 1 to Days 155
Safety as determined by abnormality in haematology
Time Frame: From Day 1 to Days 155
Measurement of red blood cell count, white blood cell count, haemoglobin and platelets
From Day 1 to Days 155
Safety as determined by abnormality in clinical chemistry
Time Frame: From Day 1 to Days 155
Measurement of kidney function (e.g.urea ,creatinine, Uric acid), liver function(ALP, ALT, AST, albumin, total bilirubin), lipid profile(total cholesterol, triglycerides), ions.
From Day 1 to Days 155
Safety as determined by abnormality in urinalysis
Time Frame: From Day 1 to Days 155
Measurement of glucose, ketones, leukocytes, blood and protein
From Day 1 to Days 155
Safety as determined by evaluation of blood pressure in mmHg
Time Frame: From Day 1 to Days 155
Measurement of blood pressure (systolic and diastolic in mmHg)
From Day 1 to Days 155
Safety as determined by evaluation of Pulse rate in beats per minute
Time Frame: From Day 1 to Days 155
Measurement of Pulse rate in beats per minute
From Day 1 to Days 155
Safety as determined by evaluation of body temperature in degree Celsius
Time Frame: From Day 1 to Days 155
Measurement of body temperature in degree Celsius
From Day 1 to Days 155
Safety as determined by evaluation of Respiratory rate in beats per minute
Time Frame: From Day 1 to Days 155
Measurement of Respiratory rate in beats per minute
From Day 1 to Days 155
Safety as determined by analysis of 12-lead ECG variables: heart rate (beats per minute)
Time Frame: From Day 1 to Days 155
The ECG variables will be summarized by absolute value at each visit by treatment group, together with the corresponding changes from baseline.
From Day 1 to Days 155
Safety as determined by analysis of 12-lead ECG variables: PR, QRS, QT and QTcF (milliseconds)
Time Frame: From Day 1 to Days 155
The ECG variables will be summarized by absolute value at each visit by treatment group.
From Day 1 to Days 155

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum observed concentration (Cmax)
Time Frame: From Day 1 to Follow-UP ( Days2, Days 3,Days 4, Days 5, Days 6, Days 8, Days 11, Days 15, Days 22 , Days 29, Days 43, Days 64, Days 92, Days 120, Days 155)
To assess the Pharmacokinetic profile of Subcutaneously administration of SHR-1703 in healthy Chinese subjects.
From Day 1 to Follow-UP ( Days2, Days 3,Days 4, Days 5, Days 6, Days 8, Days 11, Days 15, Days 22 , Days 29, Days 43, Days 64, Days 92, Days 120, Days 155)
Time to maximum observed concentration (tmax)
Time Frame: From Day 1 to Follow-UP ( Days2, Days 3,Days 4, Days 5, Days 6, Days 8, Days 11, Days 15, Days 22 , Days 29, Days 43, Days 64, Days 92, Days 120, Days 155)
To assess the Pharmacokinetic profile of Subcutaneously administration of SHR-1703 in healthy Chinese subjects.
From Day 1 to Follow-UP ( Days2, Days 3,Days 4, Days 5, Days 6, Days 8, Days 11, Days 15, Days 22 , Days 29, Days 43, Days 64, Days 92, Days 120, Days 155)
Area under the concentration-time curve from 0 to the last measurable time point (AUC0-t)
Time Frame: From Day 1 to Follow-UP ( Days2, Days 3,Days 4, Days 5, Days 6, Days 8, Days 11, Days 15, Days 22 , Days 29, Days 43, Days 64, Days 92, Days 120, Days 155)
To assess the Pharmacokinetic profile of Subcutaneously administration of SHR-1703 in healthy Chinese subjects.
From Day 1 to Follow-UP ( Days2, Days 3,Days 4, Days 5, Days 6, Days 8, Days 11, Days 15, Days 22 , Days 29, Days 43, Days 64, Days 92, Days 120, Days 155)
Area under the concentration-time curve from 0 to infinity (AUC0-∞)
Time Frame: From Day 1 to Follow-UP ( Days2, Days 3,Days 4, Days 5, Days 6, Days 8, Days 11, Days 15, Days 22 , Days 29, Days 43, Days 64, Days 92, Days 120, Days 155)
To assess the Pharmacokinetic profile of Subcutaneously administration of SHR-1703 in healthy Chinese subjects.
From Day 1 to Follow-UP ( Days2, Days 3,Days 4, Days 5, Days 6, Days 8, Days 11, Days 15, Days 22 , Days 29, Days 43, Days 64, Days 92, Days 120, Days 155)
Apparent clearance (CL/F)
Time Frame: From Day 1 to Follow-UP ( Days2, Days 3,Days 4, Days 5, Days 6, Days 8, Days 11, Days 15, Days 22 , Days 29, Days 43, Days 64, Days 92, Days 120, Days 155)
To assess the Pharmacokinetic profile of Subcutaneously administration of SHR-1703 in healthy Chinese subjects.
From Day 1 to Follow-UP ( Days2, Days 3,Days 4, Days 5, Days 6, Days 8, Days 11, Days 15, Days 22 , Days 29, Days 43, Days 64, Days 92, Days 120, Days 155)
Apparent volume of distribution at terminal phase (Vz/F)
Time Frame: From Day 1 to Follow-UP ( Days2, Days 3,Days 4, Days 5, Days 6, Days 8, Days 11, Days 15, Days 22 , Days 29, Days 43, Days 64, Days 92, Days 120, Days 155)
To assess the Pharmacokinetic profile of Subcutaneously administration of SHR-1703 in healthy Chinese subjects.
From Day 1 to Follow-UP ( Days2, Days 3,Days 4, Days 5, Days 6, Days 8, Days 11, Days 15, Days 22 , Days 29, Days 43, Days 64, Days 92, Days 120, Days 155)
Time for concentration to decrease by 50% (concentration half-life) (t1/2)
Time Frame: From Day 1 to Follow-UP ( Days2, Days 3,Days 4, Days 5, Days 6, Days 8, Days 11, Days 15, Days 22 , Days 29, Days 43, Days 64, Days 92, Days 120, Days 155)
To assess the Pharmacokinetic profile of Subcutaneously administration of SHR-1703 in healthy Chinese subjects.
From Day 1 to Follow-UP ( Days2, Days 3,Days 4, Days 5, Days 6, Days 8, Days 11, Days 15, Days 22 , Days 29, Days 43, Days 64, Days 92, Days 120, Days 155)
Anti-drug antibody (ADA) as determined by evaluation of ADA positive percentage and ADA negative percentage
Time Frame: From Day 1 to Follow-UP ( Days 8, Days 15, Days 29, Days 92, Days 120, Days 155)
To assess the immunogenicity of SHR-1703
From Day 1 to Follow-UP ( Days 8, Days 15, Days 29, Days 92, Days 120, Days 155)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 4, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 21, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 21, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SHR-1703-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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