CompletedNCT04480762Updated Nov 14, 2022

A Trial of SHR-1703 in Healthy Adults

A Phase 1 interventional study of SHR-1703 and Placebo in Asthma, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-14.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 42
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study summary

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.

Read the 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).

Conditions studied

Asthma

In context

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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 design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 42 participants (actual)

Study arms

Experimental
SHR-1703-Subcutaneous administration of Dose 1
A single subcutaneous injection of SHR-1703 (Dose 1) or Placebo
Drug: SHR-1703 · Drug: Placebo
Experimental
SHR-1703-Subcutaneous administration of Dose 2
A single subcutaneous injection of SHR-1703 (Dose 2) or Placebo
Drug: SHR-1703 · Drug: Placebo
Experimental
SHR-1703-Subcutaneous administration of Dose 3
A single subcutaneous injection of SHR-1703 (Dose 3) or Placebo
Drug: SHR-1703 · Drug: Placebo
Experimental
SHR-1703-Subcutaneous administration of Dose 4
A single subcutaneous injection of SHR-1703 (Dose 4) or Placebo
Drug: SHR-1703 · Drug: Placebo
Experimental
SHR-1703-Subcutaneous administration of Dose 5
A single subcutaneous injection of SHR-1703 (Dose 5) or Placebo
Drug: SHR-1703 · Drug: Placebo

Interventions

DrugSHR-1703
SHR-1703
DrugPlacebo
Placebo of the SHR-1703

What researchers measure

Primary outcomes

Number of participants with Adverse events (AEs) and serious adverse events (SAEs)
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
Time frame: From Day 1 to Days 155
Safety as determined by abnormality in haematology
Measurement of red blood cell count, white blood cell count, haemoglobin and platelets
Time frame: From Day 1 to Days 155
Safety as determined by abnormality in clinical chemistry
Measurement of kidney function (e.g.urea ,creatinine, Uric acid), liver function(ALP, ALT, AST, albumin, total bilirubin), lipid profile(total cholesterol, triglycerides), ions.
Time frame: From Day 1 to Days 155
Safety as determined by abnormality in urinalysis
Measurement of glucose, ketones, leukocytes, blood and protein
Time frame: From Day 1 to Days 155
Safety as determined by evaluation of blood pressure in mmHg
Measurement of blood pressure (systolic and diastolic in mmHg)
Time frame: From Day 1 to Days 155
Safety as determined by evaluation of Pulse rate in beats per minute
Measurement of Pulse rate in beats per minute
Time frame: From Day 1 to Days 155
Safety as determined by evaluation of body temperature in degree Celsius
Measurement of body temperature in degree Celsius
Time frame: From Day 1 to Days 155
Safety as determined by evaluation of Respiratory rate in beats per minute
Measurement of Respiratory rate in beats per minute
Time frame: From Day 1 to Days 155
Safety as determined by analysis of 12-lead ECG variables: heart rate (beats per minute)
The ECG variables will be summarized by absolute value at each visit by treatment group, together with the corresponding changes from baseline.
Time frame: From Day 1 to Days 155
Safety as determined by analysis of 12-lead ECG variables: PR, QRS, QT and QTcF (milliseconds)
The ECG variables will be summarized by absolute value at each visit by treatment group.
Time frame: From Day 1 to Days 155

Secondary outcomes

Maximum observed concentration (Cmax)
To assess the Pharmacokinetic profile of Subcutaneously administration of SHR-1703 in healthy Chinese subjects.
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)
Time to maximum observed concentration (tmax)
To assess the Pharmacokinetic profile of Subcutaneously administration of SHR-1703 in healthy Chinese subjects.
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)
Area under the concentration-time curve from 0 to the last measurable time point (AUC0-t)
To assess the Pharmacokinetic profile of Subcutaneously administration of SHR-1703 in healthy Chinese subjects.
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)
Area under the concentration-time curve from 0 to infinity (AUC0-∞)
To assess the Pharmacokinetic profile of Subcutaneously administration of SHR-1703 in healthy Chinese subjects.
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)
Apparent clearance (CL/F)
To assess the Pharmacokinetic profile of Subcutaneously administration of SHR-1703 in healthy Chinese subjects.
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)
Apparent volume of distribution at terminal phase (Vz/F)
To assess the Pharmacokinetic profile of Subcutaneously administration of SHR-1703 in healthy Chinese subjects.
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)
Time for concentration to decrease by 50% (concentration half-life) (t1/2)
To assess the Pharmacokinetic profile of Subcutaneously administration of SHR-1703 in healthy Chinese subjects.
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)
Anti-drug antibody (ADA) as determined by evaluation of ADA positive percentage and ADA negative percentage
To assess the immunogenicity of SHR-1703
Time frame: From Day 1 to Follow-UP ( Days 8, Days 15, Days 29, Days 92, Days 120, Days 155)

Study locations

1 site

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

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04480762
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Responsible party: Sponsor
First posted: Jul 21, 2020
Start date: Aug 4, 2020
Primary completion: Sep 21, 2021
Completion: Sep 21, 2021
Last update: Nov 14, 2022

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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