Status:
COMPLETED
A Trial of SHR-1707 in Healthy Young Adult and Elderly Subjects
Lead Sponsor:
Atridia Pty Ltd.
Conditions:
Alzheimer Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04745104
Start Date
February 23 2021
End Date
March 21 2022
Last Update
July 12 2022
Active Locations (1)
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1
Atridia Pty Limited
Sydney, New South Wales, Australia, 2000