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Completed

NCT Number: NCT04973189

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The second Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SHR-1707

Drug

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

Placebo

Drug

A single dose of matching SHR-1707 placebo by intravenous (IV) infusion in healthy young adults.

Primary outcomes

  1. 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

  1. Area under the concentration-time curve from time 0 to last time point (AUC0-last) after SHR-1707 administration

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

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

  2. Area under the concentration-time curve from time 0 to infinity (AUC0-inf) after SHR-1707 administration

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

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

  3. Time to Cmax (Tmax) of SHR-1707

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

    Time to Cmax of SHR-1707

  4. Maximum observed concentration (Cmax) of SHR-1707

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

    Maximum observed concentration of SHR-1707

  5. Terminal elimination half-life (t1/2) of SHR-1707

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

    Terminal elimination half-life of SHR-1707

  6. Clearance (CL) of SHR-1707

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

    Clearance of SHR-1707

  7. Volume of distribution (Vss) of SHR-1707

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

    Volume of distribution of SHR-1707

  8. Mean residence time (MRT) of SHR-1707

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

    Mean residence time of SHR-1707

  9. The change from baseline in plasma Aβ40 and Aβ42 concentrations

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

    The change from baseline in plasma Aβ40 and Aβ42 concentrations will be measured to determine the degree of change over time.

  10. Number of subjects with Anti-SHR-1707 antibodies

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

    Number of subjects with positive ADA titers over time for SHR-1707

Sponsors and collaborators

Lead sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 22, 2021
Registry last updated
May 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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