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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1703-Subcutaneous administration of Dose 1 | Experimental | A single subcutaneous injection of SHR-1703 (Dose 1) or Placebo |
|
| SHR-1703-Subcutaneous administration of Dose 2 | Experimental | A single subcutaneous injection of SHR-1703 (Dose 2) or Placebo |
|
| SHR-1703-Subcutaneous administration of Dose 3 | Experimental | A single subcutaneous injection of SHR-1703 (Dose 3) or Placebo |
|
| SHR-1703-Subcutaneous administration of Dose 4 | Experimental | A single subcutaneous injection of SHR-1703 (Dose 4) or Placebo |
|
| SHR-1703-Subcutaneous administration of Dose 5 | Experimental | A single subcutaneous injection of SHR-1703 (Dose 5) or Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1703 | Drug | SHR-1703 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610044 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38805242 | Derived | 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. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Placebo | Drug | Placebo of the SHR-1703 |
|
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 |
| Time to maximum observed concentration (tmax) |
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) | 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-∞) | 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) | 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) | 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) | 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 | 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) |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |