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

Alzheimer's 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: NCT04973189
• Other study ID #: SHR-1707-101
• Status: Completed
• Phase: Phase 1
• Start date: May 8, 2021
• Est. completion date: January 13, 2022

Study information

• Verified date: May 2023
• Source: Shanghai Hengrui Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: January 13, 2022
• Est. primary completion date: January 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 Aß 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

11. More than 5 cigarettes daily for 12 months before screening

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

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

14. The instigators determined that other conditions were inappropriate for participation in this clinical trial

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• SHR-1707
A single dose of SHR-1707 by intravenous (IV) infusion in healthy young adults.
• Placebo
A single dose of matching SHR-1707 placebo by intravenous (IV) infusion in healthy young adults.
• SHR-1707
A single dose of SHR-1707 by intravenous (IV) infusion in elderly subjects.
• Placebo
A single dose of matching SHR-1707 placebo by intravenous (IV) infusion in elderly subjects.

Locations

Country	Name	City	State
China	The second Hospital of Anhui Medical University	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Hengrui Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability	Incidence and severity of adverse events	Start of Treatment to end of study (approximately 12 weeks)
Secondary	Area under the concentration-time curve from time 0 to last time point (AUC0-last) after SHR-1707 administration	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	Area under the concentration-time curve from time 0 to infinity (AUC0-inf) after SHR-1707 administration	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	Time to Cmax (Tmax) of SHR-1707	Time to Cmax of SHR-1707	Start of Treatment to end of study (approximately 12 weeks)
Secondary	Maximum observed concentration (Cmax) of SHR-1707	Maximum observed concentration of SHR-1707	Start of Treatment to end of study (approximately 12 weeks)
Secondary	Terminal elimination half-life (t1/2) of SHR-1707	Terminal elimination half-life of SHR-1707	Start of Treatment to end of study (approximately 12 weeks)
Secondary	Clearance (CL) of SHR-1707	Clearance of SHR-1707	Start of Treatment to end of study (approximately 12 weeks)
Secondary	Volume of distribution (Vss) of SHR-1707	Volume of distribution of SHR-1707	Start of Treatment to end of study (approximately 12 weeks)
Secondary	Mean residence time (MRT) of SHR-1707	Mean residence time of SHR-1707	Start of Treatment to end of study (approximately 12 weeks)
Secondary	The change from baseline in plasma Aß40 and Aß42 concentrations	The change from baseline in plasma Aß40 and Aß42 concentrations will be measured to determine the degree of change over time.	Start of Treatment to end of study (approximately 12 weeks)
Secondary	Number of subjects with Anti-SHR-1707 antibodies	Number of subjects with positive ADA titers over time for SHR-1707	Start of Treatment to end of study (approximately 12 weeks)