Skip to main content
Clinical Trials/NCT04973189
NCT04973189CompletedPhase 1

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

Shanghai Hengrui Pharmaceutical Co., Ltd.1 site in 1 country63 target enrollmentStarted: May 8, 2021Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
63
Locations
1
Primary Endpoint
Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent
  • 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 19~28 kg/m2 (inclusive)
  • 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
  • Positive hepatitis B virus (HBsAg), hepatitis C virus (HCV-Ab), or human immunodeficiency virus (HIV-Ab) at 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 Aβ antibody
  • 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
  • The instigators determined that other conditions were inappropriate for participation in this clinical trial

Arms & Interventions

placebo in elderly subject

Placebo Comparator

Intervention: Placebo (Drug)

A single dose of SHR-1707 by intravenous infusion in healthy young adults.

Experimental

Intervention: SHR-1707 (Drug)

placebo in healthy young adults.

Placebo Comparator

Intervention: Placebo (Drug)

A single dose of SHR-1707 by intravenous infusion in elderly subjects.

Experimental

Intervention: SHR-1707 (Drug)

Outcomes

Primary Outcomes

Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability

Time Frame: Start of Treatment to end of study (approximately 12 weeks)

Incidence and severity of adverse events

Secondary Outcomes

  • Clearance (CL) of SHR-1707(Start of Treatment to end of study (approximately 12 weeks))
  • Mean residence time (MRT) of SHR-1707(Start of Treatment to end of study (approximately 12 weeks))
  • Area under the concentration-time curve from time 0 to last time point (AUC0-last) after SHR-1707 administration(Start of Treatment to end of study (approximately 12 weeks))
  • Area under the concentration-time curve from time 0 to infinity (AUC0-inf) after SHR-1707 administration(Start of Treatment to end of study (approximately 12 weeks))
  • Time to Cmax (Tmax) of SHR-1707(Start of Treatment to end of study (approximately 12 weeks))
  • Number of subjects with Anti-SHR-1707 antibodies(Start of Treatment to end of study (approximately 12 weeks))
  • Maximum observed concentration (Cmax) of SHR-1707(Start of Treatment to end of study (approximately 12 weeks))
  • Terminal elimination half-life (t1/2) of SHR-1707(Start of Treatment to end of study (approximately 12 weeks))
  • The change from baseline in plasma Aβ40 and Aβ42 concentrations(Start of Treatment to end of study (approximately 12 weeks))
  • Volume of distribution (Vss) of SHR-1707(Start of Treatment to end of study (approximately 12 weeks))

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

A Study of SHR-1707 in Healthy Young Adult... | Clinical Trial