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A Study to Evaluate the Multiple Dose Ascending of PG-033 in Healthy Adult Participants.

27. Mai 2026 aktualisiert von: Prime Gene Therapeutics Co., Ltd.

A Single-center, Randomized, Double-blind, Placebo-controlled, Dose Escalation Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PG-033 by Multiple Dose Administration in Healthy Adult Participants .

The goal of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) profiles of multiple ascending oral doses(MAD) of PG-033 by directly comparing it with placebo.

Studienübersicht

Status

Noch keine Rekrutierung

Detaillierte Beschreibung

This is a single-center, randomized, double-blind, placebo-controlled, multiple-dose administration, and dose escalation phase I clinical study in adult participants aged from 18 to 45 years old (including threshold) with Healthy male and female participants.

.The multiple ascending dose (MAD) study will be conducted by increasing the dosage from low dosage level to high. Approximately 30 participants will be randomized to PG-033 or placebo in 3 dose groups.

Studientyp

Interventionell

Einschreibung (Geschätzt)

30

Phase

  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Xiaohua Hao Beijing Shijitan Hospital Affiliated to Capital Medical Univer
  • Telefonnummer: +8613466590802
  • E-Mail: xiaohualuck@sina.com

Studienorte

    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100038
        • Beijing Shijitan Hospital, Capital Medical University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

Inclusion Criteria:

  • 1. Read, understood, and signed an ICF before any investigational procedure(s) are performed..

    2. Male or female aged 18 to 45 (including threshold). 3. For male participants, the body weight should be ≥ 50.0 kg, and for female paticipants, the body weight should be ≥ 45.0 kg. The body mass index (BMI) should be within the range of 19.0 to 26.0 kg/m²(including threshold) 4. Results of vital signs examination, physical examination, clinical laboratory tests (including blood routine examination, urine routine examination, blood biochemistry examination, coagulation function examination, thyroid function examination, etc.), chest X-ray, adrenal gland color ultrasound, etc. during the screening period show normal results or, if there are abnormalities, they are judged by the investigator to have no clinical significance..

    5. Be willing to avoid pregnancy or voluntarily take effective contraceptive measures and have no sperm or egg donation plan from the signing of the informed consent form to three month after the last administration of the investigational medicinal product.

    6. Be able to communicate well with the investigator and understand and comply with the requirements of the study.

Exclusion Criteria:

  • 1. Participants with clinically significant abnormal electrocardiogram results judged by the investigator during screening.

    2. Participants known to be allergic to this product or related excipients; or participants with an allergic constitution (such as those who are allergic to two or more drugs or foods).

    3. Participants with a history of chronic diseases or severe diseases in the circulatory, urinary, respiratory, hematological and lymphatic, endocrine, immune, mental and neurological, digestive systems, etc.

    4. Participants who have undergone major surgery within 6 months before the first dose administration, or those who plan to have surgery during the study period, or those who have undergone surgery that, as judged by the investigator, will affect the evaluation of the drug's safety and pharmacokinetic characteristics.

    5. Participants who have used any drugs (including any prescription drugs, over-the-counter drugs, traditional Chinese herbal medicines) and health products within 2 weeks before the first dose administration.

    6. Participants who have used any drugs that inhibit or induce the liver's metabolism of drugs (e.g., barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole, selective serotonin reuptake inhibitors (SSRI) antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines, etc.) within 4 weeks before the first dose administration.

    7. Participants who are unable to stop consuming beverages and foods containing caffeine, alcohol, etc. (including chocolate, tea, coffee, cola, etc.), or foods that affect drug metabolism such as grapefruit, grapefruit products, pitaya, mango, pomelo, etc. from 48 hours before the first dose administration until the end of the trial, or those who are unable to stop consuming the above-mentioned diets from 48 hours before the first dose administration until the end of the trial.

    8. Participants who have received live attenuated vaccine vaccination within 4 weeks before the first dose administration or those who need to receive live attenuated vaccine vaccination during the trial.

    9. Participants with positive serological results for hepatitis B surface antigen (HBsAg), hepatitis C antibody, Treponema pallidum antibody, or human immunodeficiency virus antibody during screening.

    10. Participants who have participated in other clinical trials within 3 months before the first dose administration.

    11. Participants who have donated blood or lost a total of ≥ 400 mL of blood (excluding physiological blood loss in females) within 3 months before the first dose administration, received blood transfusion or used blood products, or those who plan to donate blood during the trial or within 1 month (30 days) after the end of the trial.

    12. Participants who have consumed an average of more than 2 units of alcohol per day within 30 days before screening (1 unit ≈ 360 mL of beer or 45 mL of liquor with an alcohol content of 40% or 150 mL of wine), or those who cannot abstain from alcohol during the trial, or those with a positive result in the alcohol breath test.

    13. Participants who have smoked an average of more than 5 cigarettes per day within 3 months before screening, or those who cannot stop smoking during the trial.

    14. Participants with a history of drug abuse within 1 year before screening or those who tested positive for drug abuse screening.

    15. Participants who cannot tolerate intravenous puncture/indwelling needle or those with a history of fainting at the sight of needles or blood.

    16. Participants with special dietary requirements and who cannot accept the unified diet.

    17. Pregnant or lactating women; 18. Other participants determined by the investigator to be unsuitable for participation.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Multiple Ascending Doses of PG-033 tablets
arm1: 20 mg each time, twice daily for 7 days; arm2: 60 mg each time, twice daily for 7 days; arm3: 90 mg each time, once daily for 7 days;
Oral tablets (2mg, 10mg)
Placebo-Komparator: Placebo
arm1: 20 mg each time, twice daily for 7 days; arm2: 60 mg each time, twice daily for 7 days; arm3: 90 mg each time, once daily for 7 days;
Oral tablets (2mg, 10mg) (matching corresponding study medication)

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Safety and tolerability of PG-033 tablets
Zeitfenster: 17 days
Incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs)
17 days

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pharmacokinetics-Cmax
Zeitfenster: D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Maximum Observed Plasma concentration (Cmax)
D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Pharmacokinetics-Tmax
Zeitfenster: D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Time at which the maximum plasma concentration (Cmax) occurs
D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Pharmacokinetics-AUC0-t
Zeitfenster: D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Area under the plasma concentration-time curve from dosing (time zero) to the time of the last measured concentration
D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Pharmacokinetics-AUC0-∞
Zeitfenster: 1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Area Under the Plasma Concentration Versus Time Curve from Zero Extrapolated to Infinity (AUC0-∞)
1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Pharmacokinetics-t1/2
Zeitfenster: D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Terminal Elimination Half-Life (t1/2)
D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Pharmacokinetics-Vd/F
Zeitfenster: D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Volume of Distribution (Vd/F)
D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Pharmacokinetics-CL/F
Zeitfenster: D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Total Body Clearance
D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Pharmacokinetics-λZ
Zeitfenster: D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Elimination rate constant(λz)
D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Pharmacokinetics-MRT
Zeitfenster: D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Mean retention time (MRT)
D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Pharmacokinetics-AUC_%Extrap
Zeitfenster: 1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
AUC Extrap/ AUC0-∞(AUC_%Extrap)
1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Pharmacokinetics-Cmax,ss
Zeitfenster: D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Maximum plasma concentration at steady state(Cmax,ss)
D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Pharmacokinetics-Tmax,ss
Zeitfenster: D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Time to steady state Cmax(Tmax,ss)
D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Pharmacokinetics-T1/2,ss
Zeitfenster: D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Terminal Elimination Half-Life at steady state (t1/2)
D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Pharmacokinetics-AUC 0-τ
Zeitfenster: D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Area under the plasma concentration-time curve during a dosing interval (tau) at steady state (AUC 0-τ)
D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Pharmacokinetics-AUC0-∞, ss
Zeitfenster: 1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Area Under the Plasma Concentration Versus Time Curve from Zero Extrapolated to Infinity at steady-state (AUC0-∞)
1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Pharmacokinetics-Cav,ss
Zeitfenster: D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Average plasma drug concentration during a dosing interval at steady state(Cav,ss)
D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Pharmacokinetics-Cmin,ss
Zeitfenster: D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 ,48 and 72 hours post-dose
Minimum drug concentration at steady state(Cmin,ss)
D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 ,48 and 72 hours post-dose
Pharmacokinetics-Vd,ss/F
Zeitfenster: D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Pharmacokinetics-Vd,ss/F Apparent volume of distribution at steady state after extravascular administration(Vd,ss/F)
D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Pharmacokinetics-λz,ss
Zeitfenster: D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Elimination rate constant at steady-state(λz,ss)
D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Pharmacokinetics-CLss/F
Zeitfenster: D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Apparent plasma clearance of drug after extravascular administration at steady state(CLss/F)
D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
Pharmacokinetics- Rac
Zeitfenster: D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 ,36,48 and 72 hours post-dose
Accumulation ratio(Rac)
D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 ,36,48 and 72 hours post-dose
Pharmacokinetics-DF
Zeitfenster: D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
egree of Fluctuation(DF)
D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose

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Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

4. Juni 2026

Primärer Abschluss (Geschätzt)

30. September 2026

Studienabschluss (Geschätzt)

30. Dezember 2026

Studienanmeldedaten

Zuerst eingereicht

20. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. Mai 2026

Zuerst gepostet (Tatsächlich)

1. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • PG-033-ND-102
  • CTR20261968 (Andere Kennung: https://www.chinadrugtrials.org.cn/index.html)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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