Single-dose ascending and food-effect testing of PG-033 in healthy adults

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 Single Dose Administration and Food Effect in Healthy Volunteers

This trial will test single oral doses of PG-033 in healthy adults to see how the body processes the drug and whether a high-fat meal changes its effects.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Prime Gene Therapeutics Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07013097 on ClinicalTrials.gov

What this trial studies

This Phase I study enrolls healthy adults aged 18–45 to measure safety, tolerability, pharmacokinetics and metabolic pathways of single ascending oral doses of PG-033 compared with placebo. The single ascending dose (SAD) portion randomizes about 40 participants 3:1 to PG-033 or placebo across five dose levels in a randomized, double-blind, placebo-controlled design. A separate open-label food-effect crossover enrolls 12 participants in two sequences to compare PK after fasting versus after a high-fat meal with a 7-day washout. Cardiac QTc intervals and blood/urine samples for metabolite analysis will be collected to characterize safety and drug disposition.

Who should consider this trial

Good fit: Ideal participants are healthy men or women aged 18–45 with BMI 19.0–26.0 kg/m² (and meeting the study's weight thresholds), willing to use effective contraception if applicable and to comply with study procedures.

Not a fit: People with active medical conditions, those outside the specified age or BMI ranges, pregnant or planning pregnancy, or those unable to attend the Beijing site are unlikely to be eligible or to gain direct benefit from participation.

Why it matters

Potential benefit: If successful, the study could define a safe dose range and clarify how food affects PG-033 so later trials can test whether it relieves itching in people with lichen simplex chronicus.

How similar studies have performed: Single-dose and food-effect pharmacokinetic studies are standard and have supported development of other antipruritic drugs, but PG-033 itself appears novel and untested in humans.

Eligibility criteria

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 subjects, the body weight should be ≥ 50.0 kg, and for female subjects, 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 abnormal electrocardiogram results during screening (e.g., QT/QTcF \> 440 ms, PR interval \> 200 ms, QRS complex duration \> 100 ms, clinically significant abnormalities of the P wave, clinically significant changes in the ST-T wave, etc.).

  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.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Shijitan Hospital , Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Xiaohua Hao Beijing Shijitan Hospital Affiliated to Capital Medical Univer

Conditions Lichen Simplex Chronicus; PG-033; Pruritus