A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Intravenous Administration of SHR-1707 in Healthy Young Adult and Elderly Subjects

Shanghai Hengrui Pharmaceutical Co., Ltd.1 site in 1 country63 target enrollmentMay 8, 2021

ConditionsAlzheimer's Disease

InterventionsPlacebo SHR-1707

DrugsSHR-1707 Placebo

Overview

Phase: Phase 1
Intervention: Placebo
Conditions: Alzheimer's Disease
Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Enrollment: 63
Locations: 1
Primary Endpoint: Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single intravenous administration of SHR-1707 in healthy young adult and elderly subjects.

Registry

clinicaltrials.gov

Start Date

May 8, 2021

End Date

January 13, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent
•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\~28 kg/m2 (inclusive)
•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
•Positive hepatitis B virus (HBsAg), hepatitis C virus (HCV-Ab), or human immunodeficiency virus (HIV-Ab) at 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 Aβ antibody
•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

Arms & Interventions

placebo in elderly subject

Intervention: Placebo

A single dose of SHR-1707 by intravenous infusion in healthy young adults.

Intervention: SHR-1707

placebo in healthy young adults.

Intervention: Placebo

A single dose of SHR-1707 by intravenous infusion in elderly subjects.

Intervention: SHR-1707

Outcomes

Primary Outcomes

Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability

Time Frame: Start of Treatment to end of study (approximately 12 weeks)

Incidence and severity of adverse events

Secondary Outcomes

Clearance (CL) of SHR-1707(Start of Treatment to end of study (approximately 12 weeks))
Mean residence time (MRT) of SHR-1707(Start of Treatment to end of study (approximately 12 weeks))
Area under the concentration-time curve from time 0 to last time point (AUC0-last) after SHR-1707 administration(Start of Treatment to end of study (approximately 12 weeks))
Area under the concentration-time curve from time 0 to infinity (AUC0-inf) after SHR-1707 administration(Start of Treatment to end of study (approximately 12 weeks))
Time to Cmax (Tmax) of SHR-1707(Start of Treatment to end of study (approximately 12 weeks))
Number of subjects with Anti-SHR-1707 antibodies(Start of Treatment to end of study (approximately 12 weeks))
Maximum observed concentration (Cmax) of SHR-1707(Start of Treatment to end of study (approximately 12 weeks))
Terminal elimination half-life (t1/2) of SHR-1707(Start of Treatment to end of study (approximately 12 weeks))
The change from baseline in plasma Aβ40 and Aβ42 concentrations(Start of Treatment to end of study (approximately 12 weeks))
Volume of distribution (Vss) of SHR-1707(Start of Treatment to end of study (approximately 12 weeks))