Asthma
Conditions
Brief summary
This is a single center, randomized, double-blind, placebo-controlled, single and multiple dose escalation phase 1 study. The objective of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous administered SHR-1819 in healthy subjects
Interventions
DRUGSHR-1819
SHR-1819 will be subcutaneously administered with different dose levels;
DRUGPlacebo
Placebo will be subcutaneously administered with different dose levels;
Sponsors
Shanghai Hengrui Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial, and provides written informed consent. 2. Be able to comply with all the requirements and able to complete the study. 3. Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form. 4. No clinically significant abnormalities in medical history, general physical examination, vital signs, and laboratory tests. 5. Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods and have no plan to have a child from signing the consent form to 16 weeks after IP administration.
Exclusion criteria
1. Positive hepatitis B virus (HBsAg), hepatitis C virus (HCV-Ab), human immunodeficiency virus (HIV-Ab), or QuantiFERON-TB Gold tests at screening; 2. Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening (according to the date of signed consent form), or in the follow-up period of a clinical study 3. Severe injuries or surgeries within 6 months before screening or plan to do surgeries during the trial 4. Any other circumstances that, in the investigator's judgment, may increase the risk associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Start of Treatment to end of study（about 13 weeks） | Incidence and severity of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics-AUC0-inf | Start of Treatment to end of study (approximately 13 weeks) | Area under the concentration-time curve from time 0 to infinity after SHR-1819 administration |
| Pharmacokinetics-Tmax | Up to 13 weeks | Time to Cmax of SHR-1819 |
| Pharmacokinetics-Cmax | Up to 13 weeks | Maximum observed concentration of SHR-1819 |
| Pharmacokinetics-CL/F | Up to 13 weeks | Apparent clearance of SHR-1819 |
| Pharmacokinetics-Vz/F | Up to 13 weeks | Apparent volume of distribution during terminal phase of SHR-1819 |
| Pharmacokinetics-t1/2 | Up to 13 weeks | Terminal elimination half-life of SHR-1819 |
| Pharmacokinetics-AUC0-last | Start of Treatment to end of study (about 13 weeks) | Area under the concentration-time curve from time 0 to last time point after SHR-1819 administration |
| Change from baseline to end of treatment for IgE | Up to 13 weeks | IgE |
| Immunogenicy of SHR-1819 after administration | Up to 13 weeks] | Anti-drug antibody |
| Pharmacokinetics-AUCtau for multi-dose | Start of Treatment to end of study (about 13 weeks) | Area under the concentration-time curve from time 0 to last time point after SHR-1819 administration |
| Pharmacokinetics- Ctrough for multi-dose | Up to 13 weeks | Minimum observed concentration of SHR-1819 |
| Pharmacokinetics- Racc for multi-dose | Up to 13 weeks | Accumulation ratio of SHR-1819 |
| Change from baseline to end of treatment for Thymus and activation-regulated chemokine（TARC/CCL17） | Up to 13 weeks | Thymus and activation-regulated chemokine（TARC/CCL17） |
Countries
China
Outcome results
None listed