A Trial of SHR-1707 in Healthy Young Adult and Elderly Subjects
11 juli 2022 uppdaterad av: 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
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
50
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
New South Wales
-
Sydney, New South Wales, Australien, 2000
- Atridia Pty Limited
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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 kommer att administreras genom IV-infusion
|
|
Experimentell: 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 kommer att administreras genom IV-infusion
|
|
Experimentell: 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 kommer att administreras genom IV-infusion
|
|
Experimentell: 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 kommer att administreras genom IV-infusion
|
|
Experimentell: 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 kommer att administreras genom IV-infusion
|
|
Experimentell: 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 kommer att administreras genom IV-infusion
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Adverse events
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pharmacokinetics-AUC0-last
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
23 februari 2021
Primärt slutförande (Faktisk)
21 mars 2022
Avslutad studie (Faktisk)
21 mars 2022
Studieregistreringsdatum
Först inskickad
1 december 2020
Först inskickad som uppfyllde QC-kriterierna
6 februari 2021
Första postat (Faktisk)
9 februari 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
12 juli 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 juli 2022
Senast verifierad
1 juli 2022
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SHR-1707-I-101-AUS
Plan för individuella deltagardata (IPD)
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Nej
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