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

2026년 5월 27일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

상세 설명

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.

연구 유형

중재적

등록 (추정된)

30

단계

  • 1단계

연락처 및 위치

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연구 연락처

  • 이름: Xiaohua Hao Beijing Shijitan Hospital Affiliated to Capital Medical Univer
  • 전화번호: +8613466590802
  • 이메일: xiaohualuck@sina.com

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

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예

설명

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.

공부 계획

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연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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)
위약 비교기: 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)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Safety and tolerability of PG-033 tablets
기간: 17 days
Incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs)
17 days

2차 결과 측정

결과 측정
측정값 설명
기간
Pharmacokinetics-Cmax
기간: 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
기간: 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
기간: 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-∞
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 4일

기본 완료 (추정된)

2026년 9월 30일

연구 완료 (추정된)

2026년 12월 30일

연구 등록 날짜

최초 제출

2026년 5월 20일

QC 기준을 충족하는 최초 제출

2026년 5월 27일

처음 게시됨 (실제)

2026년 6월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 27일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

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

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

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미국 FDA 규제 기기 제품 연구

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이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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