Clinical trial NCT04973189: A Study 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-07-22
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: SHR-1707 compared with placebo
Primary purpose: BASIC_SCIENCE

Brief 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 criteria: 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
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

Primary outcomes:
measure: Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability
timeFrame: Start of Treatment to end of study (approximately 12 weeks)
Secondary outcomes:
measure: Area under the concentration-time curve from time 0 to last time point (AUC0-last) after SHR-1707 administration
timeFrame: Start of Treatment to end of study (approximately 12 weeks)
measure: Area under the concentration-time curve from time 0 to infinity (AUC0-inf) after SHR-1707 administration
timeFrame: Start of Treatment to end of study (approximately 12 weeks)
measure: Time to Cmax (Tmax) of SHR-1707
timeFrame: Start of Treatment to end of study (approximately 12 weeks)
measure: Maximum observed concentration (Cmax) of SHR-1707
timeFrame: Start of Treatment to end of study (approximately 12 weeks)
measure: Terminal elimination half-life (t1/2) of SHR-1707
timeFrame: Start of Treatment to end of study (approximately 12 weeks)
measure: Clearance (CL) of SHR-1707
timeFrame: Start of Treatment to end of study (approximately 12 weeks)
measure: Volume of distribution (Vss) of SHR-1707
timeFrame: Start of Treatment to end of study (approximately 12 weeks)
measure: Mean residence time (MRT) of SHR-1707
timeFrame: Start of Treatment to end of study (approximately 12 weeks)
measure: The change from baseline in plasma Aβ40 and Aβ42 concentrations
timeFrame: Start of Treatment to end of study (approximately 12 weeks)
measure: Number of subjects with Anti-SHR-1707 antibodies
timeFrame: Start of Treatment to end of study (approximately 12 weeks)
Other outcomes:
Locations:
city: Hefei
country: China
facility: The second Hospital of Anhui Medical University
state: Anhui
Study officials:
References: