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A Trial of SHR-1707 in Healthy Young Adult and Elderly Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Trial of SHR-1707 in Healthy Young Adult and Elderly Subjects

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

NCT04745104•Atridia Pty Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial,
•2. 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
•3. Total body weight of 45\~100 kg (inclusive), with a body mass index (BMI) of 19\~32 kg/m2 (inclusive) at screening and baseline
•4. 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
•5. WOCBP agree to take effective contraceptive methods

Exclusion Criteria

•1. Severe injuries or surgeries within 6 months before screening
•2. ALT, or AST or total bilirubin level \<1.5x upper limit of normal range (ULN) at screening or baseline visits
•3. QTcF \> 450msec (Male), QTcF \> 470msec (Female) in 12-lead ECG test during screening and baseline
•4. Known history or suspected of being allergic to the study drug.
•5. 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
•6. Live (attenuated) vaccination within 1 month before screening
•7. Blood donation or loss of more than 400 mL of blood within 3 months; or received blood transfusion within 3 months before screening.
•8. History of alcohol abuse in the past 12 months of screening
•9. History of illicit or prescription drug abuse or addiction within 12 months of screening
•10. More than 5 cigarettes daily for 12 months before screening
+2 more criteria

Locations (1)

Atridia Pty Limited

Sydney, New South Wales, Australia

Key Dates

Start Date

February 23, 2021

Primary Completion Date

March 21, 2022

Completion Date

March 21, 2022

Last Updated

July 12, 2022

Enrollment

ACTUAL participants

Conditions

Alzheimer Disease

Interventions

SHR-1707

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 12, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Trial of SHR-1707 in Healthy Young Adult and Elderly Subjects

Inclusion Criteria

Exclusion Criteria

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