- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05328583
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral HRS5685 in Healthy Subjects
A Phase I Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral HRS5685 in Healthy Subjects
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Fase
- Fase 1
Kontakter og plasseringer
Studiekontakt
- Navn: Liping Ma
- Telefonnummer: 0518-82342973
- E-post: liping.ma@hengrui.com
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Able and willing to provide written informed consent and to comply with the study protocol;
- Must be 18 to 45 years of age (inclusive);
- Body weight of at least 50 kg for male, and 45 kg for female; and Body Mass Index (BMI) within the range of 18 to 28 kg/m2 (inclusive);
- Physical examination, vital signs, laboratory tests, 12-lead ECG, eGFR (CKD-EPI formula), abdominal ultrasound and chest radiograph are normal or are judged not clinically significant by the investigator;
- Subjects (including partners) of childbearing potential are willing to useprotocol specified effective methods of contraception from screening to at least 8 months (for female) or 6 months (for male) after the final dose of study drug;
Exclusion Criteria:
- History or presence of any clinically significant cardiovascular, endocrine, neurological, gastrointestinal, respiratory, hematological, immunological, psychiatric, metabolic disorders or any diseases that may interfere with the study results;
- Subjects with severe infections, severe trauma or major surgical operation within 3 months before drug administration; or subjects plan to undergo surgery during the trial and within two weeks after the end of trial;
- Abnormal ECG that is clinically significant, or QTcF< 300 msec or >450 msec for men and >460 msec for women;
- Positive test result of any of the following at screening: hepatitis B surface antigen (HBsAg), hepatitis C antibody, syphilis, or human immunodeficiency virus (HIV) antibody;
- Suspected allergy to any ingredient in the study drug;
- Use of any drug that inhibits or induces hepatic metabolism within 1 month prior to the first dose of study drug;
- Any condition or disease that affects the absorption, metabolism, and/or excretion of the study drug as judged by the investigator;
- Use of any prescription or over-the-counter medication, including herbal medications within 1 month prior to the first dose of study drug;
- Participation in clinical trials of any drug or medical device (except for screening failures) within 3 months before screening, or within 5 half-lives of the drug at screening (whichever is longer);
- Receiving vaccine(s) within 1 month prior to the first dose of study drug;
- Donation or loss of blood of ≥ 200 mL within 1 month or of ≥ 400 mL within 3 months prior to the first dose of study drug; or receiving blood transfusion within 8 weeks prior to the first dose of study drug; or have difficulty in venous blood collection, or whose physical condition cannot withstand intensive blood sampling;
- An average daily smoking of ≥ 5 cigarettes or an average daily alcohol intake of 15 g (15 g alcohol is equivalent to 450 mL beer or 150 mL wine or 50 mL low-alcohol liquor) within 3 months before screening;
- Subjects who cannot refrain from smoking and alcohol intake from 2 days before the start of study treatment until the last follow-up;
- Subjects who consume alcoholic beverages, Seville oranges, grapefruit or juices, or products containing caffeine or xanthine (such as coffee, tea, cola drinks and chocolate) from 2 days before the start of study treatment, and those who have special dietary requirements and cannot comply with the unified diet;
- Subjects with a history of drug abuse, drug dependence, or a positive drugs of abuse test, or a positive alcohol breath test before study drug administration;
- Pregnant or lactating females;
- Other conditions judged by the investigator to be not suitable to participate in the trial;
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Treatment group A(Part A)
Drug1: HRS5685, dose 1; Drug2: Placebo
|
Drug1: HRS5685 Single dose in group A-F and multiple doses in group G-H Drug2: Placebo Single dose in group A-F and multiple doses in group G-H |
|
Eksperimentell: Treatment group B(Part A)
Drug1: HRS5685, dose 2; Drug2: Placebo
|
Drug1: HRS5685 Single dose in group A-F and multiple doses in group G-H Drug2: Placebo Single dose in group A-F and multiple doses in group G-H |
|
Eksperimentell: Treatment group C(Part A)
Drug1: HRS5685, dose 3; Drug2: Placebo
|
Drug1: HRS5685 Single dose in group A-F and multiple doses in group G-H Drug2: Placebo Single dose in group A-F and multiple doses in group G-H |
|
Eksperimentell: Treatment group D(Part A)
Drug1: HRS5685, dose 4; Drug2: Placebo
|
Drug1: HRS5685 Single dose in group A-F and multiple doses in group G-H Drug2: Placebo Single dose in group A-F and multiple doses in group G-H |
|
Eksperimentell: Treatment group E(Part A)
Drug1: HRS5685, dose 5; Drug2: Placebo
|
Drug1: HRS5685 Single dose in group A-F and multiple doses in group G-H Drug2: Placebo Single dose in group A-F and multiple doses in group G-H |
|
Eksperimentell: Treatment group F(Part A)
Drug1: HRS5685, dose 6; Drug2: Placebo
|
Drug1: HRS5685 Single dose in group A-F and multiple doses in group G-H Drug2: Placebo Single dose in group A-F and multiple doses in group G-H |
|
Eksperimentell: Treatment group G(Part B)
Drug1: HRS5685, dose 3; Drug2: Placebo
|
Drug1: HRS5685 Single dose in group A-F and multiple doses in group G-H Drug2: Placebo Single dose in group A-F and multiple doses in group G-H |
|
Eksperimentell: Treatment group H(Part B)
Drug1: HRS5685, dose 4; Drug2: Placebo
|
Drug1: HRS5685 Single dose in group A-F and multiple doses in group G-H Drug2: Placebo Single dose in group A-F and multiple doses in group G-H |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Safety and tolerability: Incidence and severity of adverse events
Tidsramme: Up to Day 63 after the last dose
|
Up to Day 63 after the last dose
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Area under the concentration-time curve during a dosing interval (AUCtau),
Tidsramme: Pre-dose up to Day 63 after the last dose
|
Pre-dose up to Day 63 after the last dose
|
|
Area under the concentration-time curve from time zero to the last quantifiable time point t (AUC0-t)
Tidsramme: Pre-dose up to Day 63 after the last dose
|
Pre-dose up to Day 63 after the last dose
|
|
Area under the concentration-time curve extrapolated to infinity (AUC0-inf )
Tidsramme: Pre-dose up to Day 63 after the last dose
|
Pre-dose up to Day 63 after the last dose
|
|
Maximum observed concentration (Cmax)
Tidsramme: Pre-dose up to Day 63 after the last dose
|
Pre-dose up to Day 63 after the last dose
|
|
Time to Maximum observed concentration (Tmax)
Tidsramme: Pre-dose up to Day 63 after the last dose
|
Pre-dose up to Day 63 after the last dose
|
|
Half-life (t1/2),
Tidsramme: Pre-dose up to Day 63 after the last dose
|
Pre-dose up to Day 63 after the last dose
|
|
Apparent clearance (CL/F)
Tidsramme: Pre-dose up to Day 63 after the last dose
|
Pre-dose up to Day 63 after the last dose
|
|
Apparent volume of distribution (Vz/F)
Tidsramme: Pre-dose up to Day 63 after the last dose
|
Pre-dose up to Day 63 after the last dose
|
|
Trough concentration (Ctrough)
Tidsramme: Pre-dose up to Day 63 after the last dose
|
Pre-dose up to Day 63 after the last dose
|
|
Accumulation ratio (Rac),
Tidsramme: Pre-dose up to Day 63 after the last dose
|
Pre-dose up to Day 63 after the last dose
|
|
Renal clearance (CLr)
Tidsramme: Pre-dose up to 72 hours post-dose
|
Pre-dose up to 72 hours post-dose
|
|
Cumulative amount of drug excreted (Ae)
Tidsramme: Pre-dose up to 72 hours post-dose
|
Pre-dose up to 72 hours post-dose
|
|
Cumulative percentage of dose recovered (fe)
Tidsramme: Pre-dose up to 72 hours post-dose
|
Pre-dose up to 72 hours post-dose
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- RNA-virusinfeksjoner
- Virussykdommer
- Infeksjoner
- Blodbårne infeksjoner
- Smittsomme sykdommer
- Seksuelt overførbare sykdommer, virale
- Seksuelt overførbare sykdommer
- Lentivirus infeksjoner
- Retroviridae-infeksjoner
- Immunologiske mangelsyndromer
- Sykdommer i immunsystemet
- Langsomme virussykdommer
- HIV-infeksjoner
- Ervervet immunsviktsyndrom
Andre studie-ID-numre
- HRS5685-101
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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