- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04745104
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
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New South Wales
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Sydney, New South Wales, Australien, 2000
- Atridia Pty Limited
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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:
- 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
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 |
|---|---|---|
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Adverse events
Tidsramme: Start of Treatment to end of study (approximately 12 weeks)
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Incidence and severity of adverse events
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Start of Treatment to end of study (approximately 12 weeks)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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
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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
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Start of Treatment to end of study (approximately 12 weeks)
|
|
Pharmacokinetics-Tmax
Tidsramme: Start of Treatment to end of study (approximately 12 weeks)
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Time to Cmax of SHR-1707
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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)
|
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Pharmacokinetics-CL/F
Tidsramme: Start of Treatment to end of study (approximately 12 weeks)
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Apparent clearance of SHR-1707
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Start of Treatment to end of study (approximately 12 weeks)
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Pharmacokinetics-Vz/F
Tidsramme: Start of Treatment to end of study (approximately 12 weeks)
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Apparent volume of distribution during terminal phase of SHR-1707
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Start of Treatment to end of study (approximately 12 weeks)
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Pharmacokinetics-t1/2
Tidsramme: Start of Treatment to end of study (approximately 12 weeks)
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Terminal elimination half-life of SHR-1707
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Start of Treatment to end of study (approximately 12 weeks)
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Pharmacokinetics MRT
Tidsramme: Start of Treatment to end of study (approximately 12 weeks)
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Mean residence time of SHR-1707
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Start of Treatment to end of study (approximately 12 weeks)
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Pharmacodynamics
Tidsramme: Start of Treatment to end of study (approximately 12 weeks)
|
Change from baseline of plasma biomarker concentrations
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Start of Treatment to end of study (approximately 12 weeks)
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Anti-Drug antibody
Tidsramme: Start of Treatment to end of study (approximately 12 weeks)
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The percentage of subjects with positive ADA titers over time for SHR-1707.
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Start of Treatment to end of study (approximately 12 weeks)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SHR-1707-I-101-AUS
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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