Asthma
Conditions
Brief summary
This is a randomized, double-blind, placebo-controlled, single dose escalation phase 1 study. The objective of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of subcutaneous administered SHR-1905 in healthy subjects.
Detailed description
The study will consist of one dose esclation part with a total of 5 dose levels. The Subjects will be randomized to receive SHR-1905 as reflected by the guiding principle for the dose esclation/expansion phase. Each dose group includes a screening period, a baseline period, an observational period, and a safety follow-up period.
Interventions
DRUGSHR-1905
SHR-1905 will be injected subcutaneously
DRUGPlacebo
Placebo will be injected subcutaneously
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
1. Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial. 2. Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form. 3. Total body weight ≥45 kg at screening, and body mass index (BMI) between 18 and 28 kg/m2 (inclusive). 4. For healthy subjects, no clinically significant abnormalities. 5. Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods
Exclusion criteria
1. Known medical history of severe disease in cardiovascular, liver, kidney, digestive tract, mental nerve, hematology, metabolic disorders, etc. 2. Severe injuries or major surgeries within 6 months before screening. 3. Subjects with infecious disease. 4. Hyper/Hypotension at screening and at check in. 5. Clinically significant abnormalities in 12-Lead ECG 6. More than 5 cigarettes daily (or products with equivalent amount of nicotine) for 3 months prior to screening 7. Positive urine drug screen . 8. Subject who cannot perform venous blood sampling. 9. Known history or suspected of being allergic to the study drugs and their excipients. 10. Use of any medicine within 4-weeks or within 5 half-lives 11. History of alcohol abuse within 3 months prior to the IP administration . 12. Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening 13. in the investigator's judgment, may increase the risk to the subject
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Start of Treatment to end of study (approximately 16 weeks) | Incidence and severity of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics-AUC0-inf | Start of Treatment to end of study (approximately 16 weeks) | Area under the concentration-time curve from time 0 to infinity after SHR-1905 administration |
| Pharmacokinetics-Tmax | Start of Treatment to end of study (approximately 16 weeks) | Time to Cmax of SHR-1905 |
| Pharmacokinetics-Cmax | Start of Treatment to end of study (approximately 16 weeks) | Maximum observed concentration of SHR-1905 |
| Pharmacokinetics-AUC0-last | Start of Treatment to end of study (approximately 16 weeks) | Area under the concentration-time curve from time 0 to last time point after SHR-1905 administration |
| Pharmacokinetics-Vz/F | Start of Treatment to end of study (approximately 16 weeks) | Apparent volume of distribution during terminal phase of SHR-1905 |
| Pharmacokinetics-t1/2 | Start of Treatment to end of study (approximately 16 weeks) | Terminal elimination half-life of SHR-1905 |
| Anti-Drug antibody | Start of Treatment to end of study (approximately 16 weeks) | The percentage of subjects with positive ADA titers over time for SHR-1905 |
| Pharmacokinetics-CL/F | Start of Treatment to end of study (approximately 16 weeks) | Apparent clearance of SHR-1905 |
Countries
Australia
Outcome results
None listed