A Trial of SHR-1703 in Healthy Subjects
- Registration Number
- NCT04855591
- Lead Sponsor
- Atridia Pty Ltd.
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
- Healthy Caucasian subjects, male and female, 18 to 55 years of age, inclusive;
- Body weight ≥45 kg (Both male and female), body mass index (BMI) between ≥19.0 and ≤29.9 kg/m2, inclusive;
- 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.
- 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.
- Known history or suspected of being allergic to the study drug.
- Positive hepatitis B virus (HBsAg), hepatitis C virus (HCV-Ab), human immunodeficiency virus (HIV-Ab) at screening.
- 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
- Use of any medicine within 4-weeks prior to the IP administration
- 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.
- Live (attenuated) vaccination within 1 month before screening or plan to be vaccinated
- Severe injuries or major surgeries within 6 months before screening or plan to do surgeries during the trial
- Patients with known or suspected parasitic infection within 6 months before screening
- 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)
- More than 5 cigarettes daily (or products with equivalent amount of nicotine) for 3 months prior to screening.
- History of alcohol abuse within 3 months prior to the IP administration
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SHR-1703 Dose Level 1 SHR-1703 Dose level 1 SHR-1703 SHR-1703 Dose Level 3 Placebo Dose level 3 SHR-1703 SHR-1703 Dose Level 3 SHR-1703 Dose level 3 SHR-1703 SHR-1703 Dose Level 2 Placebo Dose level 2 SHR-1703 SHR-1703 Dose Level 1 Placebo Dose level 1 SHR-1703 SHR-1703 Dose Level 2 SHR-1703 Dose level 2 SHR-1703 SHR-1703 Dose Level 4 (optional) SHR-1703 Dose level 4 SHR-1703 Additional dose escalations, as determined by the SMC depend on PK and safety data review SHR-1703 Dose Level 4 (optional) Placebo Dose level 4 SHR-1703 Additional dose escalations, as determined by the SMC depend on PK and safety data review
- Primary Outcome Measures
Name Time Method Adverse events Start of Treatment to end of study (approximately 34 weeks) Incidence and severity of adverse events
- Secondary Outcome Measures
Name Time Method 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-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
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
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-t1/2 Start of Treatment to end of study (approximately 34 weeks) Terminal elimination half-life of SHR-1703
Trial Locations
- Locations (1)
Nucleus Network
🇦🇺Brisbane, Queensland, Australia