A Trial of SHR-1703 in Healthy Adults

NCT04480762 | Completed Phase 1

• 1 other identifier: SHR-1703-101
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (10)

• 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

  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

  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.

  From Day 1 to Days 155

• Safety as determined by abnormality in urinalysis

  Measurement of glucose, ketones, leukocytes, blood and protein

  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)

  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

  From Day 1 to Days 155

• Safety as determined by evaluation of body temperature in degree Celsius

  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

  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)

  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)

  The ECG variables will be summarized by absolute value at each visit by treatment group.

  From Day 1 to Days 155

Secondary Outcomes (8)

• Maximum observed concentration (Cmax)

  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)

  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)

  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-∞)

  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)

  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)

Study Arms (5)

SHR-1703-Subcutaneous administration of Dose 1

EXPERIMENTAL

A single subcutaneous injection of SHR-1703 (Dose 1) or Placebo

Drug: SHR-1703; Drug: Placebo

SHR-1703-Subcutaneous administration of Dose 2

EXPERIMENTAL

A single subcutaneous injection of SHR-1703 (Dose 2) or Placebo

Drug: SHR-1703; Drug: Placebo

SHR-1703-Subcutaneous administration of Dose 3

EXPERIMENTAL

A single subcutaneous injection of SHR-1703 (Dose 3) or Placebo

Drug: SHR-1703; Drug: Placebo

SHR-1703-Subcutaneous administration of Dose 4

EXPERIMENTAL

A single subcutaneous injection of SHR-1703 (Dose 4) or Placebo

Drug: SHR-1703; Drug: Placebo

SHR-1703-Subcutaneous administration of Dose 5

EXPERIMENTAL

A single subcutaneous injection of SHR-1703 (Dose 5) or Placebo

Drug: SHR-1703; Drug: Placebo

Interventions

SHR-1703 DRUG

SHR-1703

SHR-1703-Subcutaneous administration of Dose 1; SHR-1703-Subcutaneous administration of Dose 2; SHR-1703-Subcutaneous administration of Dose 3; SHR-1703-Subcutaneous administration of Dose 4; SHR-1703-Subcutaneous administration of Dose 5

Placebo DRUG

Placebo of the SHR-1703

SHR-1703-Subcutaneous administration of Dose 1; SHR-1703-Subcutaneous administration of Dose 2; SHR-1703-Subcutaneous administration of Dose 3; SHR-1703-Subcutaneous administration of Dose 4; SHR-1703-Subcutaneous administration of Dose 5

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610044, China

Location

Related Publications (1)

• Yang L, Fang Y, Luo Y, Fu M, Shen K, Luo Z. Safety, pharmacokinetics and pharmacodynamics of SHR-1703, an innovative long-acting anti-interleukin-5 monoclonal antibody, in healthy subjects: a randomized, double-blind, dose-escalation, placebo-controlled phase I study. Expert Opin Investig Drugs. 2024 Jul;33(7):741-752. doi: 10.1080/13543784.2024.2361065. Epub 2024 Jun 3.

  PMID: 38805242 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System 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

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 21, 2020
• Study Start: August 4, 2020
• Primary Completion: September 21, 2021
• Study Completion: September 21, 2021
• Last Updated: November 14, 2022

Record last verified: 2022-11

Locations

CN (1)