Back to results

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

Primary Purpose

Alzheimer Disease

Status

Completed

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

SHR-1707

Placebo

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Atridia Pty Limited

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

SHR-1707 Dose level 1

SHR-1707 Dose level 2

SHR-1707 Dose level 3

SHR-1707 Dose level 4

SHR-1707 Dose level 5

SHR-1707 Dose level 3 (Elderly subjects)

Arm Description

SHR-1707 or placebo is administered intravenous to young healthy subjects

SHR-1707 or placebo is administered intravenous to Elderly subjects

Outcomes

Primary Outcome Measures

Adverse events

Incidence and severity of adverse events

Secondary Outcome Measures

Pharmacokinetics-AUC0-last

Area under the concentration-time curve from time 0 to last time point after SHR-1707 administration

Pharmacokinetics-AUC0-inf

Area under the concentration-time curve from time 0 to infinity after SHR-1707 administration

Pharmacokinetics-Tmax

Time to Cmax of SHR-1707

Pharmacokinetics-Cmax

Maximum observed concentration of SHR-1707

Pharmacokinetics-CL/F

Apparent clearance of SHR-1707

Pharmacokinetics-Vz/F

Apparent volume of distribution during terminal phase of SHR-1707

Pharmacokinetics-t1/2

Terminal elimination half-life of SHR-1707

Pharmacokinetics MRT

Mean residence time of SHR-1707

Pharmacodynamics

Change from baseline of plasma biomarker concentrations

Anti-Drug antibody

The percentage of subjects with positive ADA titers over time for SHR-1707.

Full Information

NCT ID

NCT04745104

First Posted

December 1, 2020

Last Updated

July 11, 2022

Sponsor

Atridia Pty Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04745104

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

February 23, 2021 (Actual)

Primary Completion Date

March 21, 2022 (Actual)

Study Completion Date

March 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Atridia Pty Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SHR-1707 Dose level 1

Arm Type

Experimental

Arm Description

SHR-1707 or placebo is administered intravenous to young healthy subjects

Arm Title

SHR-1707 Dose level 2

Arm Type

Experimental

Arm Description

SHR-1707 or placebo is administered intravenous to young healthy subjects

Arm Title

SHR-1707 Dose level 3

Arm Type

Experimental

Arm Description

SHR-1707 or placebo is administered intravenous to young healthy subjects

Arm Title

SHR-1707 Dose level 4

Arm Type

Experimental

Arm Description

SHR-1707 or placebo is administered intravenous to young healthy subjects

Arm Title

SHR-1707 Dose level 5

Arm Type

Experimental

Arm Description

SHR-1707 or placebo is administered intravenous to young healthy subjects

Arm Title

SHR-1707 Dose level 3 (Elderly subjects)

Arm Type

Experimental

Arm Description

SHR-1707 or placebo is administered intravenous to Elderly subjects

Intervention Type

Drug

Intervention Name(s)

SHR-1707

Intervention Description

SHR-1707 will be administered through IV infusion

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo will be administered through IV infusion

Primary Outcome Measure Information:

Title

Adverse events

Description

Incidence and severity of adverse events

Time Frame

Start of Treatment to end of study (approximately 12 weeks)

Secondary Outcome Measure Information:

Title

Pharmacokinetics-AUC0-last

Description

Area under the concentration-time curve from time 0 to last time point after SHR-1707 administration

Time Frame

Start of Treatment to end of study (approximately 12 weeks)

Title

Pharmacokinetics-AUC0-inf

Description

Area under the concentration-time curve from time 0 to infinity after SHR-1707 administration

Time Frame

Start of Treatment to end of study (approximately 12 weeks)

Title

Pharmacokinetics-Tmax

Description

Time to Cmax of SHR-1707

Time Frame

Start of Treatment to end of study (approximately 12 weeks)

Title

Pharmacokinetics-Cmax

Description

Maximum observed concentration of SHR-1707

Time Frame

Start of Treatment to end of study (approximately 12 weeks)

Title

Pharmacokinetics-CL/F

Description

Apparent clearance of SHR-1707

Time Frame

Start of Treatment to end of study (approximately 12 weeks)

Title

Pharmacokinetics-Vz/F

Description

Apparent volume of distribution during terminal phase of SHR-1707

Time Frame

Start of Treatment to end of study (approximately 12 weeks)

Title

Pharmacokinetics-t1/2

Description

Terminal elimination half-life of SHR-1707

Time Frame

Start of Treatment to end of study (approximately 12 weeks)

Title

Pharmacokinetics MRT

Description

Mean residence time of SHR-1707

Time Frame

Start of Treatment to end of study (approximately 12 weeks)

Title

Pharmacodynamics

Description

Change from baseline of plasma biomarker concentrations

Time Frame

Start of Treatment to end of study (approximately 12 weeks)

Title

Anti-Drug antibody

Description

The percentage of subjects with positive ADA titers over time for SHR-1707.

Time Frame

Start of Treatment to end of study (approximately 12 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Atridia Pty Limited

City

Sydney

State/Province

New South Wales

ZIP/Postal Code

2000

Country

Australia

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs