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Completed

NCT Number: NCT04745104

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Atridia Pty Limited

Sydney, New South Wales, 2000, Australia

About this study

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.

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, voluntarily participate in the trial,
  • 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 19~32 kg/m2 (inclusive) at screening and baseline
  • 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
  • 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 the study drug.
  • 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

Treatment and study plan

SHR-1707

Drug

SHR-1707 will be administered through IV infusion

Placebo

Drug

Placebo will be administered through IV infusion

Primary outcomes

  1. Adverse events

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

    Incidence and severity of adverse events

Secondary outcomes

  1. Pharmacokinetics-AUC0-last

    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. Pharmacokinetics-AUC0-inf

    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. Pharmacokinetics-Tmax

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

    Time to Cmax of SHR-1707

  4. Pharmacokinetics-Cmax

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

    Maximum observed concentration of SHR-1707

  5. Pharmacokinetics-CL/F

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

    Apparent clearance of SHR-1707

  6. Pharmacokinetics-Vz/F

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

    Apparent volume of distribution during terminal phase of SHR-1707

  7. Pharmacokinetics-t1/2

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

    Terminal elimination half-life of SHR-1707

  8. Pharmacokinetics MRT

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

    Mean residence time of SHR-1707

  9. Pharmacodynamics

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

    Change from baseline of plasma biomarker concentrations

  10. Anti-Drug antibody

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

    The percentage of subjects with positive ADA titers over time for SHR-1707.

Sponsors and collaborators

Lead sponsor

Atridia Pty 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
Feb 9, 2021
Registry last updated
Jul 12, 2022

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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