A Trial of SHR-1707 in Healthy Young Adult and Elderly Subjects
- Registration Number
- NCT04745104
- Lead Sponsor
- Atridia Pty Ltd.
- Brief Summary
A randomized, double-blind, placebo-controlled, single dose escalation phase 1 study to access the Pharmacokinetics and Pharmacodynamics of Single Intravenous Administration of SHR-1707
- Detailed Description
The study will consist of two parts: Subjects will be randomized to receive SHR-1707 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
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial,
- Male or female aged between 18 years and 45 years (inclusive) at the date of signed consent form in Part 1 and aged between 55 years and 80 years (inclusive) in Part 2
- Total body weight of 45~100 kg (inclusive), with a body mass index (BMI) of 19~32 kg/m2 (inclusive) at screening and baseline
- Subjects with good general health, no clinically significant abnormalities, or have underlying disease which is believed to have minimal impact on the study treatment in elderly subjects
- WOCBP agree to take effective contraceptive methods
Exclusion Criteria
- Severe injuries or surgeries within 6 months before screening
- ALT, or AST or total bilirubin level <1.5x upper limit of normal range (ULN) at screening or baseline visits
- QTcF > 450msec (Male), QTcF > 470msec (Female) in 12-lead ECG test during screening and baseline
- Known history or suspected of being allergic to the study drug.
- Use of any medicine within 14 days (including any prescription, or over-the-counter medicine, herbal remedy or nutritional supplement, except for vitamins and acetaminophen with recommended dose [The dose of acetaminophen should be less than 2g/day, and no more than 3 days for continuous use]), or within 5 half-lives
- Live (attenuated) vaccination within 1 month before screening
- Blood donation or loss of more than 400 mL of blood within 3 months; or received blood transfusion within 3 months before screening.
- History of alcohol abuse in the past 12 months of screening
- History of illicit or prescription drug abuse or addiction within 12 months of screening
- More than 5 cigarettes daily for 12 months before screening
- Participation in clinical trials of other investigational drugs (include placebo) or medical devices within 3 months prior to screening
- Researchers and relevant staff of the research center or other persons directly involved in the implementation of the program
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SHR-1707 Dose level 3 (Elderly subjects) SHR-1707 SHR-1707 or placebo is administered intravenous to Elderly subjects SHR-1707 Dose level 3 Placebo SHR-1707 or placebo is administered intravenous to young healthy subjects SHR-1707 Dose level 1 Placebo SHR-1707 or placebo is administered intravenous to young healthy subjects SHR-1707 Dose level 2 SHR-1707 SHR-1707 or placebo is administered intravenous to young healthy subjects SHR-1707 Dose level 5 Placebo SHR-1707 or placebo is administered intravenous to young healthy subjects SHR-1707 Dose level 2 Placebo SHR-1707 or placebo is administered intravenous to young healthy subjects SHR-1707 Dose level 4 Placebo SHR-1707 or placebo is administered intravenous to young healthy subjects SHR-1707 Dose level 3 (Elderly subjects) Placebo SHR-1707 or placebo is administered intravenous to Elderly subjects SHR-1707 Dose level 4 SHR-1707 SHR-1707 or placebo is administered intravenous to young healthy subjects SHR-1707 Dose level 1 SHR-1707 SHR-1707 or placebo is administered intravenous to young healthy subjects SHR-1707 Dose level 3 SHR-1707 SHR-1707 or placebo is administered intravenous to young healthy subjects SHR-1707 Dose level 5 SHR-1707 SHR-1707 or placebo is administered intravenous to young healthy subjects
- Primary Outcome Measures
Name Time Method Adverse events Start of Treatment to end of study (approximately 12 weeks) Incidence and severity of adverse events
- Secondary Outcome Measures
Name Time Method Pharmacokinetics-CL/F Start of Treatment to end of study (approximately 12 weeks) Apparent clearance of SHR-1707
Pharmacodynamics Start of Treatment to end of study (approximately 12 weeks) Change from baseline of plasma biomarker concentrations
Pharmacokinetics-AUC0-last Start of Treatment to end of study (approximately 12 weeks) Area under the concentration-time curve from time 0 to last time point after SHR-1707 administration
Pharmacokinetics-AUC0-inf Start of Treatment to end of study (approximately 12 weeks) Area under the concentration-time curve from time 0 to infinity after SHR-1707 administration
Pharmacokinetics-Tmax Start of Treatment to end of study (approximately 12 weeks) Time to Cmax of SHR-1707
Pharmacokinetics-Vz/F Start of Treatment to end of study (approximately 12 weeks) Apparent volume of distribution during terminal phase of SHR-1707
Pharmacokinetics-t1/2 Start of Treatment to end of study (approximately 12 weeks) Terminal elimination half-life of SHR-1707
Pharmacokinetics-Cmax Start of Treatment to end of study (approximately 12 weeks) Maximum observed concentration of SHR-1707
Pharmacokinetics MRT Start of Treatment to end of study (approximately 12 weeks) Mean residence time of SHR-1707
Anti-Drug antibody Start of Treatment to end of study (approximately 12 weeks) The percentage of subjects with positive ADA titers over time for SHR-1707.
Trial Locations
- Locations (1)
Atridia Pty Limited
🇦🇺Sydney, New South Wales, Australia