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

Alzheimer Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04745104
• Other study ID #: SHR-1707-I-101-AUS
• Status: Completed
• Phase: Phase 1
• Start date: February 23, 2021
• Est. completion date: March 21, 2022

Study information

• Verified date: July 2022
• Source: Atridia Pty Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 21, 2022
• Est. primary completion date: March 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

11. Participation in clinical trials of other investigational drugs (include placebo) or medical devices within 3 months prior to screening

12. Researchers and relevant staff of the research center or other persons directly involved in the implementation of the program

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• SHR-1707
SHR-1707 will be administered through IV infusion
• Placebo
Placebo will be administered through IV infusion

Locations

Country	Name	City	State
Australia	Atridia Pty Limited	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Atridia Pty Ltd.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Incidence and severity of adverse events	Start of Treatment to end of study (approximately 12 weeks)
Secondary	Pharmacokinetics-AUC0-last	Area under the concentration-time curve from time 0 to last time point after SHR-1707 administration	Start of Treatment to end of study (approximately 12 weeks)
Secondary	Pharmacokinetics-AUC0-inf	Area under the concentration-time curve from time 0 to infinity after SHR-1707 administration	Start of Treatment to end of study (approximately 12 weeks)
Secondary	Pharmacokinetics-Tmax	Time to Cmax of SHR-1707	Start of Treatment to end of study (approximately 12 weeks)
Secondary	Pharmacokinetics-Cmax	Maximum observed concentration of SHR-1707	Start of Treatment to end of study (approximately 12 weeks)
Secondary	Pharmacokinetics-CL/F	Apparent clearance of SHR-1707	Start of Treatment to end of study (approximately 12 weeks)
Secondary	Pharmacokinetics-Vz/F	Apparent volume of distribution during terminal phase of SHR-1707	Start of Treatment to end of study (approximately 12 weeks)
Secondary	Pharmacokinetics-t1/2	Terminal elimination half-life of SHR-1707	Start of Treatment to end of study (approximately 12 weeks)
Secondary	Pharmacokinetics MRT	Mean residence time of SHR-1707	Start of Treatment to end of study (approximately 12 weeks)
Secondary	Pharmacodynamics	Change from baseline of plasma biomarker concentrations	Start of Treatment to end of study (approximately 12 weeks)
Secondary	Anti-Drug antibody	The percentage of subjects with positive ADA titers over time for SHR-1707.	Start of Treatment to end of study (approximately 12 weeks)