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New treatment option for Lichen Simplex Chronicus
Official title A Phase I Clinical Trial to Evaluate the Single Dose Ascending and Food Effects of PG-033 in Healthy Adults
ClinicalTrials.gov ID: NCT07013097
What this study is testing
What is PG-033?
PG-033 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for lichen simplex chronicus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) profiles of single ascending oral doses(SAD) of PG-033 by directly comparing it with placebo. Meanwhile, the impact of a high-fat meal on the pharmacokinetics of PG-033 will also be evaluated.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45. Healthy volunteers may be eligible.
You may be able to join if
- 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 people, the body weight should be ≥ 50.0 kg, and for female people, the body weight...
- 4\. Results of vital signs examination, physical examination, clinical laboratory tests (including blood routine examination, urine routine...
- 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...
- 6\. Be able to communicate well with the investigator and understand and comply with the requirements of the study.
You likely can't join if
- 1\. Participants with abnormal electrocardiogram results during screening (e.g., QT/QTcF \> 440 ms, PR interval \> 200 ms, QRS complex duration \>...
- 2\. Participants known to be allergic to this product or related excipients; or participants with an allergic constitution (such as those who are...
- 3\. Participants with a history of chronic diseases or severe diseases in the circulatory, urinary, respiratory, hematological and lymphatic...
- 4\. Participants who have undergone major surgery within 6 months before the first dose administration, or those who plan to have surgery during the...
- 5\. Participants who have used any drugs (including any prescription drugs, over-the-counter drugs, traditional Chinese herbal medicines) and health...
- 6\. Participants who have used any drugs that inhibit or induce the liver's metabolism of drugs (e.g., barbiturates, carbamazepine, phenytoin...
See the full eligibility 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 people, the body weight should be ≥ 50.0 kg, and for female people, the body weight should be ≥ 45.0 kg. The body mass index (BMI) should be within the...
- 4\. Results of vital signs examination, physical examination, clinical laboratory tests (including blood routine examination, urine routine examination, blood biochemistry examination, coagulation function examination...
- 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...
- 6\. Be able to communicate well with the investigator and understand and comply with the requirements of the study.
- 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...
- 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...
- 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)...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.