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

11. juli 2022 opdateret af: Atridia Pty Ltd.

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

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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

50

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • New South Wales
      • Sydney, New South Wales, Australien, 2000
        • Atridia Pty Limited

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial,
  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 19~32 kg/m2 (inclusive) at screening and baseline
  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. ALT, or AST or total bilirubin level <1.5x upper limit of normal range (ULN) at screening or baseline visits
  3. QTcF > 450msec (Male), QTcF > 470msec (Female) in 12-lead ECG test during screening and baseline
  4. Known history or suspected of being allergic to the study drug.
  5. 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
  6. Live (attenuated) vaccination within 1 month before screening
  7. Blood donation or loss of more than 400 mL of blood within 3 months; or received blood transfusion within 3 months before screening.
  8. History of alcohol abuse in the past 12 months of screening
  9. History of illicit or prescription drug abuse or addiction within 12 months of screening
  10. More than 5 cigarettes daily for 12 months before screening
  11. Participation in clinical trials of other investigational drugs (include placebo) or medical devices within 3 months prior to screening
  12. Researchers and relevant staff of the research center or other persons directly involved in the implementation of the program

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: SHR-1707 Dose level 1
SHR-1707 or placebo is administered intravenous to young healthy subjects
SHR-1707 will be administered through IV infusion
Placebo vil blive indgivet gennem IV-infusion
Eksperimentel: SHR-1707 Dose level 2
SHR-1707 or placebo is administered intravenous to young healthy subjects
SHR-1707 will be administered through IV infusion
Placebo vil blive indgivet gennem IV-infusion
Eksperimentel: SHR-1707 Dose level 3
SHR-1707 or placebo is administered intravenous to young healthy subjects
SHR-1707 will be administered through IV infusion
Placebo vil blive indgivet gennem IV-infusion
Eksperimentel: SHR-1707 Dose level 4
SHR-1707 or placebo is administered intravenous to young healthy subjects
SHR-1707 will be administered through IV infusion
Placebo vil blive indgivet gennem IV-infusion
Eksperimentel: SHR-1707 Dose level 5
SHR-1707 or placebo is administered intravenous to young healthy subjects
SHR-1707 will be administered through IV infusion
Placebo vil blive indgivet gennem IV-infusion
Eksperimentel: SHR-1707 Dose level 3 (Elderly subjects)
SHR-1707 or placebo is administered intravenous to Elderly subjects
SHR-1707 will be administered through IV infusion
Placebo vil blive indgivet gennem IV-infusion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adverse events
Tidsramme: Start of Treatment to end of study (approximately 12 weeks)
Incidence and severity of adverse events
Start of Treatment to end of study (approximately 12 weeks)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pharmacokinetics-AUC0-last
Tidsramme: 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
Start of Treatment to end of study (approximately 12 weeks)
Pharmacokinetics-AUC0-inf
Tidsramme: 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
Start of Treatment to end of study (approximately 12 weeks)
Pharmacokinetics-Tmax
Tidsramme: Start of Treatment to end of study (approximately 12 weeks)
Time to Cmax of SHR-1707
Start of Treatment to end of study (approximately 12 weeks)
Pharmacokinetics-Cmax
Tidsramme: Start of Treatment to end of study (approximately 12 weeks)
Maximum observed concentration of SHR-1707
Start of Treatment to end of study (approximately 12 weeks)
Pharmacokinetics-CL/F
Tidsramme: Start of Treatment to end of study (approximately 12 weeks)
Apparent clearance of SHR-1707
Start of Treatment to end of study (approximately 12 weeks)
Pharmacokinetics-Vz/F
Tidsramme: Start of Treatment to end of study (approximately 12 weeks)
Apparent volume of distribution during terminal phase of SHR-1707
Start of Treatment to end of study (approximately 12 weeks)
Pharmacokinetics-t1/2
Tidsramme: Start of Treatment to end of study (approximately 12 weeks)
Terminal elimination half-life of SHR-1707
Start of Treatment to end of study (approximately 12 weeks)
Pharmacokinetics MRT
Tidsramme: Start of Treatment to end of study (approximately 12 weeks)
Mean residence time of SHR-1707
Start of Treatment to end of study (approximately 12 weeks)
Pharmacodynamics
Tidsramme: Start of Treatment to end of study (approximately 12 weeks)
Change from baseline of plasma biomarker concentrations
Start of Treatment to end of study (approximately 12 weeks)
Anti-Drug antibody
Tidsramme: Start of Treatment to end of study (approximately 12 weeks)
The percentage of subjects with positive ADA titers over time for SHR-1707.
Start of Treatment to end of study (approximately 12 weeks)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

23. februar 2021

Primær færdiggørelse (Faktiske)

21. marts 2022

Studieafslutning (Faktiske)

21. marts 2022

Datoer for studieregistrering

Først indsendt

1. december 2020

Først indsendt, der opfyldte QC-kriterier

6. februar 2021

Først opslået (Faktiske)

9. februar 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juli 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juli 2022

Sidst verificeret

1. juli 2022

Mere information

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Kliniske forsøg med SHR-1707

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