Healthy Volunteers
Conditions
Brief summary
This is a single center, randomized, double-blind, placebo-controlled, single dose escalation phase 1 study.
Detailed description
This is a single center, randomized, double-blind, placebo-controlled, single 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
Atridia Pty Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial, and provides written informed consent. * Be able to comply with all the requirements and able to complete the study. * Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form. * No clinically significant abnormalities in medical history, general physical examination, vital signs, and laboratory tests. * 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
* Positive hepatitis B virus (HBsAg), hepatitis C virus (HCV-Ab), human immunodeficiency virus (HIV-Ab), or QuantiFERON-TB Gold tests at screening; * 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 * Severe injuries or surgeries within 6 months before screening or plan to do surgeries during the trial * 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 (approximately 13 weeks) | Incidence and severity of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 (approximately 13 weeks) | Area under the concentration-time curve from time 0 to last time point after SHR-1819 administration |
| Pharmacokinetics-Cmax | Up to 13 weeks | Maximum observed concentration of SHR-1819 |
| Pharmacokinetics-Tmax | Up to 13 weeks | Time to Cmax of SHR-1819 |
| Change from baseline to end of treatment for TARC/CCL17 | Up to 13 weeks | TARC/CCL17 |
| 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-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 |
Countries
Australia
Outcome results
None listed