Lichen Simplex ChronicusPhase 1NCT07013097
A Phase I Clinical Trial to Evaluate the Single Dose Ascending and Food Effects of PG-033 in Healthy Adults
A Phase 1 study testing PG-033 in people with Lichen Simplex Chronicus, run by Prime Gene Therapeutics Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Lichen Simplex Chronicus
- What is being tested?
- PG-033
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 23 May 2025to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Xiaohua Hao Beijing Shijitan Hospital Affiliated to Capital Medical Univer contact
China1 site, 1 recruiting
- Recruiting
Beijing Shijitan Hospital , Capital Medical University
Beijing, Beijing Municipality, 100038
Xiaohua Hao, +86 13466590802, xiaohualuck@sina.com
About this study
Official title: 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
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. The research will also explore the potential metabolites and metabolic pathways of PG-033 within the human body，as well as investigate the effect of PG-033 on the QTc interval.
Read the detailed description
This is a single-center, randomized, double-blind, placebo-controlled, single-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 subjects. The study includs a single dose ascending study (SAD) and a food effect (FE) study.
The single ascending dose (SAD) study will be conducted by increasing the dosage from low dosage level to high. Approximately 40 participants will be randomized 3:1 to PG-033 or placebo in 5 dose groups.
The food effect study adopts a single-center, randomized, open-label, single-dose, two-period and two-sequence crossover clinical trial design. 12 participants will be randomly divided into group A and group B, with 6 participants in each group. In the first period, the 6 subjects in Group A will take PG-033 on an empty stomach, while the 6 subjects in Group B will take PG-033 after having a high-fat meal. In the second period, the two groups will cross over in taking the drug. That is, the subjects in Group A will take PG-033 after having a high-fat meal, and the subjects in Group B will take PG-033 on an empty stomach. The washout period between the two dosing periods is 7 days.
- Conditions
- Lichen Simplex Chronicus
- Being tested
- PG-033, PG-033 placebo comparator
- Keywords
- PG-033, Lichen Simplex Chronicus, Pruritus
- Medical subject headings
- Neurodermatitis, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PG-033Drug
Oral tablets (2mg， 10mg)
PG-033 placebo comparatorDrug
Oral tablets (2 mg, 10 mg) (matching corresponding study medication)
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Doses of PG-033 tablets | Active comparator | Not described Receives: Drug: PG-033 |
| Placebo | Placebo comparator | Not described Receives: Drug: PG-033 placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of PG-033 tablets
Incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs)
Measured: Single Ascending Dose study: 7 days；Food Effect study: 14 days
Secondary outcomes (10)
Pharmacokinetics parameter: Cmax
Maximum Observed Plasma concentration (Cmax)
Measured: up to 3 days
Pharmacokinetics Parameter:Tmax
Time at which the maximum plasma concentration (Cmax) occurs
Measured: up to 3 days
Pharmacokinetics parameter: AUC0-t
Area under the plasma concentration-time curve from dosing (time zero） to the time of the last measured concentration
Measured: up to 3 days
Pharmacokinetics parameter: AUC0-∞
Area Under the Plasma Concentration Versus Time Curve from Zero Extrapolated to Infinity (AUC0-∞）
Measured: up to 3 days
Pharmacokinetics parameter: t1/2
Terminal Elimination Half-Life (t1/2)
Measured: up to 3 days
Pharmacokinetics parameter: Vd/F
Volume of Distribution (Vd/F)
Measured: up to 3 days
Pharmacokinetics parameter: CL/F
Total Body Clearance
Measured: up to 3 days
Pharmacokinetics parameter: λZ
Elimination rate constant (λz)
Measured: up to 3 days
Pharmacokinetics parameter: MRT
Mean retention time (MRT)
Measured: up to 3 days
Corrected QT interval
Change in QT interval corrected for heart rate (QTc) interval from baseline
Measured: up to 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start23 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lichen Simplex ChronicusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prime Gene Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013097
- Sponsor's protocol ID
- PG-033-ND-101
- Other IDs
- CTR20251749
- Status last verified
- Jun 2025
- First submitted
- 19 May 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07013097
- Acronym / sponsor ID
- PG-033-ND-101
- Conditions
- Lichen Simplex Chronicus
- Keywords
- PG-033, Lichen Simplex Chronicus, Pruritus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Prime Gene Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. The research will also explore the potential metabolites and metabolic pathways of PG-033 within the human body，as well as investigate the effect of PG-033 on the QTc interval.
Detailed description
This is a single-center, randomized, double-blind, placebo-controlled, single-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 subjects. The study includs a single dose ascending study (SAD) and a food effect (FE) study.
The single ascending dose (SAD) study will be conducted by increasing the dosage from low dosage level to high. Approximately 40 participants will be randomized 3:1 to PG-033 or placebo in 5 dose groups.
The food effect study adopts a single-center, randomized, open-label, single-dose, two-period and two-sequence crossover clinical trial design. 12 participants will be randomly divided into group A and group B, with 6 participants in each group. In the first period, the 6 subjects in Group A will take PG-033 on an empty stomach, while the 6 subjects in Group B will take PG-033 after having a high-fat meal. In the second period, the two groups will cross over in taking the drug. That is, the subjects in Group A will take PG-033 after having a high-fat meal, and the subjects in Group B will take PG-033 on an empty stomach. The washout period between the two dosing periods is 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Doses of PG-033 tablets | Active comparator | Drug: PG-033 |
| Placebo | Placebo comparator | Drug: PG-033 placebo comparator |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PG-033Oral tablets (2mg， 10mg) | Drug | Single Ascending Doses of PG-033 tablets |
| PG-033 placebo comparatorOral tablets (2 mg, 10 mg) (matching corresponding study medication) | Drug | Placebo |
Primary outcome
Safety and tolerability of PG-033 tablets
Time frame: Single Ascending Dose study: 7 days；Food Effect study: 14 days
Incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs)
10 secondary outcomes
Pharmacokinetics parameter: Cmax
Time frame: up to 3 days
Pharmacokinetics Parameter:Tmax
Time frame: up to 3 days
Pharmacokinetics parameter: AUC0-t
Time frame: up to 3 days
Pharmacokinetics parameter: AUC0-∞
Time frame: up to 3 days
Pharmacokinetics parameter: t1/2
Time frame: up to 3 days
Pharmacokinetics parameter: Vd/F
Time frame: up to 3 days
Pharmacokinetics parameter: CL/F
Time frame: up to 3 days
Pharmacokinetics parameter: λZ
Time frame: up to 3 days
Pharmacokinetics parameter: MRT
Time frame: up to 3 days
Corrected QT interval
Time frame: up to 24 hours post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaohua Hao Beijing Shijitan Hospital Affiliated to Capital Medical Univer contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PG-033 in people with Lichen Simplex Chronicus, run by Prime Gene Therapeutics Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaohua Hao Beijing Shijitan Hospital Affiliated to Capital Medical Univer (+86 13466590802, xiaohualuck@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of PG-033 tablets (time frame: Single Ascending Dose study: 7 days；Food Effect study: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.