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

COMPLETEDPHASE1

A Study 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

NCT04973189•Shanghai Hengrui Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent
•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\~28 kg/m2 (inclusive)
•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. Positive hepatitis B virus (HBsAg), hepatitis C virus (HCV-Ab), or human immunodeficiency virus (HIV-Ab) at screening
•3. ALT, or AST or total bilirubin level \<1.5x upper limit of normal range (ULN) at screening or baseline visits
•4. QTcF \> 450msec (Male), QTcF \> 470msec (Female) in 12-lead ECG test during screening and baseline
•5. Known history or suspected of being allergic to Aβ antibody
•6. 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
•7. Live (attenuated) vaccination within 1 month before screening
•8. Blood donation or loss of more than 400 mL of blood within 3 months; or received blood transfusion within 3 months before screening.
•9. History of alcohol abuse in the past 12 months of screening
•10. History of illicit or prescription drug abuse or addiction within 12 months of screening
+4 more criteria

Locations (1)

The second Hospital of Anhui Medical University

Hefei, Anhui, China

Key Dates

Start Date

May 8, 2021

Primary Completion Date

January 13, 2022

Completion Date

January 13, 2022

Last Updated

May 18, 2023

Enrollment

ACTUAL participants

Conditions

Alzheimer's Disease

Interventions

SHR-1707

DRUG

Placebo

DRUG

SHR-1707

DRUG

Placebo

DRUG

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RECRUITING

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Subjective Cognitive Decline (SCD)Functional Cognitive Disorder+2 more

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RECRUITING

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: May 18, 2023Data 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 Study of SHR-1707 in Healthy Young Adult and Elderly Subjects

Inclusion Criteria

Exclusion Criteria

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