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

May 27, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Xiaohua Hao Beijing Shijitan Hospital Affiliated to Capital Medical Univer
  • Phone Number: +8613466590802
  • Email: xiaohualuck@sina.com

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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;
Drug: PG-033 tablets
Oral tablets (2mg, 10mg)
Placebo Comparator: 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;
Drug: PG-033 placebo comparator
Oral tablets (2mg, 10mg) (matching corresponding study medication)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety and tolerability of PG-033 tablets
Time Frame: 17 days
Incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs)
17 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetics-Cmax
Time Frame: 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
Time Frame: 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
Time Frame: 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-∞
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Prime Gene Therapeutics Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 4, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PG-033-ND-102
  • CTR20261968 (Other Identifier: https://www.chinadrugtrials.org.cn/index.html)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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