A Trial of SHR-1703 in Healthy Subjects
Study Details
Study Description
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 pharmacodynamics and immunogenicity of subcutaneous administered SHR-1703 in healthy subjects.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Detailed Description
The study will consist of one dose esclation part with a total of 3 dose levels. The Subjects will be randomized to receive SHR-1703 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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: SHR-1703 Dose Level 1 Dose level 1 SHR-1703 |
Drug: SHR-1703
SHR-1703 will be administered subcutaneously
Drug: Placebo
Placebo of SHR-1703 will be administered subcutaneously
|
Experimental: SHR-1703 Dose Level 2 Dose level 2 SHR-1703 |
Drug: SHR-1703
SHR-1703 will be administered subcutaneously
Drug: Placebo
Placebo of SHR-1703 will be administered subcutaneously
|
Experimental: SHR-1703 Dose Level 3 Dose level 3 SHR-1703 |
Drug: SHR-1703
SHR-1703 will be administered subcutaneously
Drug: Placebo
Placebo of SHR-1703 will be administered subcutaneously
|
Experimental: SHR-1703 Dose Level 4 (optional) Dose level 4 SHR-1703 Additional dose escalations, as determined by the SMC depend on PK and safety data review |
Drug: SHR-1703
SHR-1703 will be administered subcutaneously
Drug: Placebo
Placebo of SHR-1703 will be administered subcutaneously
|
Outcome Measures
Primary Outcome Measures
- Adverse events [Start of Treatment to end of study (approximately 34 weeks)]
Incidence and severity of adverse events
Secondary Outcome Measures
- Pharmacokinetics-AUC0-last [Start of Treatment to end of study (approximately 34 weeks)]
Area under the concentration-time curve from time 0 to last time point after SHR-1703 administration
- Pharmacokinetics-AUC0-inf [Start of Treatment to end of study (approximately 34 weeks)]
Area under the concentration-time curve from time 0 to infinity after SHR-1703 administration
- Pharmacokinetics-Tmax [Start of Treatment to end of study (approximately 34 weeks)]
Time to Cmax of SHR-1703
- Pharmacokinetics-Cmax [Start of Treatment to end of study (approximately 34 weeks)]
Maximum observed concentration of SHR-1703
- Pharmacokinetics-CL/F [Start of Treatment to end of study (approximately 34 weeks)]
Apparent clearance of SHR-1703
- Pharmacokinetics-Vz/F [Start of Treatment to end of study (approximately 34 weeks)]
Apparent volume of distribution during terminal phase of SHR-1703
- Pharmacokinetics-t1/2 [Start of Treatment to end of study (approximately 34 weeks)]
Terminal elimination half-life of SHR-1703
- Pharmacodynamics-Eosinophils [Start of Treatment to end of study (approximately 34 weeks)]
Absolute eosinophils account and change from baseline in percentage
- Anti-drug-antibody [Start of Treatment to week 22 after IP administration]
The percentage of subjects with positive ADA titers over time for SHR-1703
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy Caucasian subjects, male and female, 18 to 55 years of age, inclusive;
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Body weight ≥45 kg (Both male and female), body mass index (BMI) between ≥19.0 and ≤29.9 kg/m2, inclusive;
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No clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests (hematology, urinalysis, blood chemistry and coagulation function) and ECG at the investigator's discretion during screening and baseline.
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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 30-days after last scheduled follow-up visit.
Exclusion Criteria:
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Known history or suspected of being allergic to the study drug.
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Positive hepatitis B virus (HBsAg), hepatitis C virus (HCV-Ab), human immunodeficiency virus (HIV-Ab) at screening.
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Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening or within 5 half-lives of any drugs during screening visit, or in the follow-up period of a clinical study whichever is longer
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Use of any medicine within 4-weeks prior to the IP administration
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Blood donation or loss of more than 400 mL of blood within 1 month of screening; or received blood transfusion within 2 months before screening.
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Live (attenuated) vaccination within 1 month before screening or plan to be vaccinated
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Severe injuries or major surgeries within 6 months before screening or plan to do surgeries during the trial
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Patients with known or suspected parasitic infection within 6 months before screening
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Either ALT, AST, ALP, GGT or total bilirubin level exceeds upper limit of normal range (ULN) at screening or baseline visits (confirmed by a single repeat, as per investigator's judgment)
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More than 5 cigarettes daily (or products with equivalent amount of nicotine) for 3 months prior to screening.
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History of alcohol abuse within 3 months prior to the IP administration
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Nucleus Network | Brisbane | Queensland | Australia |
Sponsors and Collaborators
- Atridia Pty Ltd.
Investigators
- Principal Investigator: Dr Richard Friend, Nucleus Network
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SHR-1703-104-AUS