- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 1
Kontakter och platser
Studiekontakt
- Namn: Liping Ma
- Telefonnummer: 0518-82342973
- E-post: liping.ma@hengrui.com
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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 |
|
Experimentell: 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 |
|
Experimentell: 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 |
|
Experimentell: 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 |
|
Experimentell: 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 |
|
Experimentell: 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 |
|
Experimentell: 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 |
|
Experimentell: 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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Safety and tolerability: Incidence and severity of adverse events
Tidsram: Up to Day 63 after the last dose
|
Up to Day 63 after the last dose
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Area under the concentration-time curve during a dosing interval (AUCtau),
Tidsram: 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)
Tidsram: 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 )
Tidsram: Pre-dose up to Day 63 after the last dose
|
Pre-dose up to Day 63 after the last dose
|
|
Maximum observed concentration (Cmax)
Tidsram: 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)
Tidsram: Pre-dose up to Day 63 after the last dose
|
Pre-dose up to Day 63 after the last dose
|
|
Half-life (t1/2),
Tidsram: Pre-dose up to Day 63 after the last dose
|
Pre-dose up to Day 63 after the last dose
|
|
Apparent clearance (CL/F)
Tidsram: 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)
Tidsram: Pre-dose up to Day 63 after the last dose
|
Pre-dose up to Day 63 after the last dose
|
|
Trough concentration (Ctrough)
Tidsram: Pre-dose up to Day 63 after the last dose
|
Pre-dose up to Day 63 after the last dose
|
|
Accumulation ratio (Rac),
Tidsram: Pre-dose up to Day 63 after the last dose
|
Pre-dose up to Day 63 after the last dose
|
|
Renal clearance (CLr)
Tidsram: Pre-dose up to 72 hours post-dose
|
Pre-dose up to 72 hours post-dose
|
|
Cumulative amount of drug excreted (Ae)
Tidsram: Pre-dose up to 72 hours post-dose
|
Pre-dose up to 72 hours post-dose
|
|
Cumulative percentage of dose recovered (fe)
Tidsram: Pre-dose up to 72 hours post-dose
|
Pre-dose up to 72 hours post-dose
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Förväntat)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- RNA-virusinfektioner
- Virussjukdomar
- Infektioner
- Blodburna infektioner
- Smittsamma sjukdomar
- Sexuellt överförbara sjukdomar, virala
- Sexuellt överförbara sjukdomar
- Lentivirusinfektioner
- Retroviridae-infektioner
- Immunologiska bristsyndrom
- Immunsystemets sjukdomar
- Långsamma virussjukdomar
- HIV-infektioner
- Förvärvat immunbristsyndrom
Andra studie-ID-nummer
- HRS5685-101
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
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