Atopic DermatitisPhase 1NCT07800104
Phase 1 Study of QX-4533 in Healthy Volunteers and Patients With Moderate-to-Severe Atopic Dermatitis
A Phase 1 study testing QX4533 in people with Atopic Dermatitis, run by QuantX Biosciences, Inc. at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the safety and tolerability of QX-453, an investigational treatment, in healthy Chinese volunteers and patients with moderate-to-severe atopic dermatitis. The study will assess how the drug is absorbed and processed by the body, and check for any side effects. Read more about this study
- Who is it for?
- Ages 18 months to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- QX4533
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 14 Sep 2026to 19 May 2027
- 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 months to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Part 1: Eligibility Criteria for HVs
- Participants are eligible to be included in Part 1 of the study only if all of the following criteria apply:
- Fully understanding the purpose, nature, method, and possible adverse reactions of the trial, voluntarily participating as a clinical trial participant, and signing the ICF;
- Being willing and able to comply with the study protocol and cooperate in completing the visit procedures throughout the study;
- Males and females aged 18 to 55 years (inclusive, at the time of signing the ICF) at screening;
- Body mass index (BMI) of 18 to 28 kg/m2 (inclusive); weight not less than 50 kg for male and 45 kg for female;
Show all 17Show fewer
- Participants in good general health as judged by the Investigator based on their medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory findings (normal or abnormal but not clinically significant) at screening and on Day -1;
- Female participants must be non-pregnant and non-lactating, and female participants of childbearing potential must agree to use contraception from the signing of the ICF until at least 40 days after the last dose (10 days [approximately 5 t1/2] plus 30 days). Male participants with female partners of childbearing potential must agree to use contraception from the signing of the ICF until at least 100 days after the last dose (10 days [approximately 5 t1/2] plus a 90-day spermatogenesis cycle) (by taking medically approved effective contraceptive measures. See Appendix 3 Contraceptive Measures and Definition of Women of Childbearing Potential for details). Male participants must refrain from donating sperm for at least 150 days after the last dose. Female participants must refrain from donating eggs for at least 40 days after the last dose.
- Part 2: Eligibility Criteria for Participants with AD Inclusion Criteria
- Participants are eligible to be included in Part 2 of the study only if all of the following criteria apply:
- Fully understanding the purpose, nature, method, and possible adverse reactions of the trial, voluntarily participating as a participant, and signing the ICF;
- Being willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study-related procedures and questionnaires, including completing the electronic diaries and questionnaires, for the duration of the study as required by the study protocol;
- Males and females aged 18 to 65 years (inclusive) at screening;
- Participants with chronic AD diagnosed by the Eichenfield revised criteria of Hannifin and Rajka and with a confirmed diagnosis for at least one year prior to the screening visit;
- Participants with inadequate response, intolerance, or contraindication to topical corticosteroids and/or topical calcineurin inhibitors;
- Participants must be able and willing to regularly use a mild, inactive ingredient-free emollient twice daily for at least 7 consecutive days before randomization and continue to use it during the study;
- Female participants must be non-pregnant and non-lactating, and female participants of childbearing potential must agree to use contraception from the signing of the ICF until at least 40 days after the last dose (10 days [approximately 5 t1/2] plus 30 days). Male participants with female partners of childbearing potential must agree to use contraception from the signing of the ICF until at least 100 days after the last dose (10 days [approximately 5 t1/2] plus a 90-day spermatogenesis cycle) (by taking medically approved effective contraceptive measures. See Appendix 3 Contraceptive Measures and Definition of Women of Childbearing Potential for details). Male participants must refrain from donating sperm for at least 150 days after the last dose. Female participants must refrain from donating eggs for at least 40 days after the last dose.
Who cannot join
- Part 1:
- Participants who are mentally or legally incapacitated, have a history of psychosis, or have significant emotional or psychological problems at the time of the study according to the Investigator;
- Participants with dysphagia, oesophageal stenosis, or gastrointestinal diseases that cause clinically significant symptoms such as nausea, vomiting, diarrhoea, or malabsorption syndrome, or with a history of severe vomiting or diarrhoea within one week before the screening period;
- Participants who have previously undergone surgeries that the Investigator deems may affect drug absorption, distribution, metabolism, or excretion (e.g., gastrectomy, cholecystectomy, gastric bypass, duodenal resection, colectomy);
- Participants with a history of any ongoing medical condition requiring treatment with prescription medication within two weeks prior to screening;
- Participants with a history of any infection requiring treatment with a prescription anti-infective in the past 4 weeks prior to screening;
Show all 20Show fewer
- Use of any prescription medications, health supplements, herbal supplements, traditional Chinese medicines (TCMs), Chinese patent medicines, or over-the-counter (OTC) medications (except for routine vitamin supplements) within two weeks prior to dosing;
- Participants with history of malignancy, except fully resolved basal cell carcinoma (BCC), squamous cell carcinoma (SCC), or in situ carcinoma of the uterine cervix;
- History of invasive, opportunistic infections such as histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, Pneumocystis jirovecii pneumonia, and aspergillosis (including resolved cases); John Cunningham (JC) virus (progressive multifocal leukoencephalopathy), or any active or parasitic infection in the prior 30 days;
- Participants who have undergone surgery, experienced significant blood loss, or donated more than one unit of whole blood (200 mL) within 8 weeks prior to screening, or who have donated more than one unit of plasma (100 mL) within 7 days prior to screening, or who plan to donate blood during the trial;
- Participants who have smoked more than 10 cigarettes (or equivalent nicotine-containing products) per week on average within 90 days prior to screening and are unwilling to quit smoking during hospitalization or restrict smoking to no more than 10 cigarettes (or equivalent nicotine-containing products) per week during the post-discharge period;
- Participants who have consumed more than 14 units of alcohol per week (1 unit = 360 mL of beer; 150 mL of wine; 45 mL of spirits) within 90 days prior to screening;
- Participants who have consumed tea, coffee and/or other caffeine-containing beverages, grapefruit juice, or other beverages that affect liver enzyme activity (more than 8 cups, 1 cup = 250 mL) daily within 3 months prior to screening or are unable to abstain during the trial;
- Participants with special dietary requirements or unable to follow a uniform diet (such as intolerance to standard meal foods, etc.); or participants who refuse to stop consuming pomelo/grapefruit or drinks made thereof, coffee, tea, or any food or beverage containing caffeine or rich in xanthine (such as animal offal, seafood, soy products, etc.) from 48 hours prior to dosing until the EOS;
- Participants who drink alcohol or perform strenuous physical activities (including but not limited to strenuous weightlifting, running, and cycling) from 48 hours prior to dosing until the EOS;
- Participants who are unable to complete the study due to their own reasons or are judged by the Investigator to be unsuitable for study participation for other reasons;
- Part 2:
- Participants who have required oral or intravenous antibiotics, anti-virals, anti-parasitics, anti-protozoals, or anti-fungals for the treatment of chronic or acute infection within 4 weeks prior to the screening visit;
- Planned major surgical procedure during the length of the study;
- Participants who are unable to complete the study due to their own reasons or are judged by the Investigator to be unsuitable for study participation for other reasons;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
Jing Zhang, 021-52887976, Zhangj_fudan@163.com
Wenyu Wu
About this study
Official title: A 2-Part Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of QX-4533 in Healthy Volunteers and of Multiple Doses of QX-4533 in Participants With Moderate-to-Severe Atopic Dermatitis
The goal of this clinical trial is to evaluate the safety and tolerability of QX-453, an investigational treatment, in healthy Chinese volunteers and patients with moderate-to-severe atopic dermatitis. The study will assess how the drug is absorbed and processed by the body, and check for any side effects. Participants will receive single or repeated oral doses of QX-453 under close medical supervision, with regular safety and clinical assessments throughout the trial.
- Conditions
- Atopic Dermatitis
- Being tested
- QX4533, QX4533 Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QX4533Drug
QX-4533, an oral investigational drug, administered as oral tablets in single or repeated dose escalation schedules for moderate-to-severe atopic dermatitis patients and healthy volunteers
QX4533 PlaceboDrug
QX-4533 placebo, an oral investigational drug, administered as oral tablets in single or repeated dose escalation schedules for moderate-to-severe atopic dermatitis patients and healthy volunteers
| Study group | Role | What they receive |
|---|---|---|
| QX4533 | Experimental | oral tablets administered once daily Receives: Drug: QX4533 |
| QX4533 Placebo | Placebo comparator | oral tablets administered once daily Receives: Drug: QX4533 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-emergent Adverse Events (TEAEs)
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Measured: From enrollment through the safety follow-up visit (up to Day 9 [Part 1] and Day 43 [Part 2])
Number of Participants with Clinically Significant Laboratory Parameter Changes
Number of Participants with Clinically Significant Change from Baseline in Clinical Laboratory Parameters
Measured: From enrollment through the safety follow-up visit (up to Day 9 [Part 1] and Day 43 [Part 2])
Secondary outcomes (8)
Maximum Observed Plasma Concentration (Cmax)
Measured: Day 1 (Part 1); Day 1 (Part 2)
Time of the Maximum Measured Concentration (Tmax)
Measured: Day 1 (Part 1); Day 1 (Part 2)
Area Under the Concentration-Time Curve from Time Zero to the Last Quantifiable concentration-time point (AUClast)
Measured: Day 1 (Part 1); Day 1 (Part 2)
Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUCinf)
Measured: Day 1 (Part 1); Day 1 (Part 2)
Apparent Volume of Distribution at Steady State (Vz/F)
Measured: Day 1 (Part 1)
Apparent Clearance (CL/F)
Measured: Day 1 (Part 1)
Terminal Elimination Half-Life (t½el)
Measured: Day 1 (Part 1)
STAT6 biomarkers
Measured: Day 1, Day 8,Day 15, Day 22,Day 29, Day 36, and Day 43 (Part 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start14 Sep 2026
- Primary completion14 Apr 2027 (estimated)
- Study completion19 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- QuantX Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800104
- Sponsor's protocol ID
- QX4533-002
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2-Part Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of QX-4533 in Healthy Volunteers and of Multiple Doses of QX-4533 in Participants With Moderate-to-Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07800104
- Acronym / sponsor ID
- QX4533-002
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- QuantX Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2026 (actual)
- Primary completion
- 14 Apr 2027 (estimated)
- Study completion
- 19 May 2027 (estimated)
- First posted
- 2 Sep 2026 (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 clinical trial is to evaluate the safety and tolerability of QX-453, an investigational treatment, in healthy Chinese volunteers and patients with moderate-to-severe atopic dermatitis. The study will assess how the drug is absorbed and processed by the body, and check for any side effects. Participants will receive single or repeated oral doses of QX-453 under close medical supervision, with regular safety and clinical assessments throughout the trial.
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 |
|---|---|---|
| QX4533 | Experimental | Drug: QX4533oral tablets administered once daily |
| QX4533 Placebo | Placebo comparator | Drug: QX4533 Placebooral tablets administered once daily |
Who may qualify
- Ages
- 18 months to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- Part 1: Eligibility Criteria for HVs
- Participants are eligible to be included in Part 1 of the study only if all of the following criteria apply:
- Fully understanding the purpose, nature, method, and possible adverse reactions of the trial, voluntarily participating as a clinical trial participant, and signing the ICF;
- Being willing and able to comply with the study protocol and cooperate in completing the visit procedures throughout the study;
- Males and females aged 18 to 55 years (inclusive, at the time of signing the ICF) at screening;
Key exclusion criteria (20 listed)
- Participants who are mentally or legally incapacitated, have a history of psychosis, or have significant emotional or psychological problems at the time of the study according to the Investigator;
- Participants with dysphagia, oesophageal stenosis, or gastrointestinal diseases that cause clinically significant symptoms such as nausea, vomiting, diarrhoea, or malabsorption syndrome, or with a history of severe vomiting or diarrhoea within one week before the screening period;
- Participants who have previously undergone surgeries that the Investigator deems may affect drug absorption, distribution, metabolism, or excretion (e.g., gastrectomy, cholecystectomy, gastric bypass, duodenal resection, colectomy);
- Participants with a history of any ongoing medical condition requiring treatment with prescription medication within two weeks prior to screening;
- Participants with a history of any infection requiring treatment with a prescription anti-infective in the past 4 weeks prior to screening;
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 |
|---|---|---|
| QX4533QX-4533, an oral investigational drug, administered as oral tablets in single or repeated dose escalation schedules for moderate-to-severe atopic dermatitis patients and healthy volunteers | Drug | QX4533 |
| QX4533 PlaceboQX-4533 placebo, an oral investigational drug, administered as oral tablets in single or repeated dose escalation schedules for moderate-to-severe atopic dermatitis patients and healthy volunteers | Drug | QX4533 Placebo |
Primary outcome
Incidence of Treatment-emergent Adverse Events (TEAEs)
Time frame: From enrollment through the safety follow-up visit (up to Day 9 [Part 1] and Day 43 [Part 2])
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Number of Participants with Clinically Significant Laboratory Parameter Changes
Time frame: From enrollment through the safety follow-up visit (up to Day 9 [Part 1] and Day 43 [Part 2])
Number of Participants with Clinically Significant Change from Baseline in Clinical Laboratory Parameters
8 secondary outcomes
Maximum Observed Plasma Concentration (Cmax)
Time frame: Day 1 (Part 1); Day 1 (Part 2)
Time of the Maximum Measured Concentration (Tmax)
Time frame: Day 1 (Part 1); Day 1 (Part 2)
Area Under the Concentration-Time Curve from Time Zero to the Last Quantifiable concentration-time point (AUClast)
Time frame: Day 1 (Part 1); Day 1 (Part 2)
Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUCinf)
Time frame: Day 1 (Part 1); Day 1 (Part 2)
Apparent Volume of Distribution at Steady State (Vz/F)
Time frame: Day 1 (Part 1)
Apparent Clearance (CL/F)
Time frame: Day 1 (Part 1)
Terminal Elimination Half-Life (t½el)
Time frame: Day 1 (Part 1)
STAT6 biomarkers
Time frame: Day 1, Day 8,Day 15, Day 22,Day 29, Day 36, and Day 43 (Part 2)
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 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Atopic Dermatitis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
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.
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 QX4533 in people with Atopic Dermatitis, run by QuantX Biosciences, Inc. 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 17 inclusion and 20 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 Oct 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 Yan Liu (+86 18782948571, yan.liu16@tigermedgrp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-emergent Adverse Events (TEAEs) (time frame: From enrollment through the safety follow-up visit (up to Day 9 [Part 1] and Day 43 [Part 2])). The study lists 2 primary outcomes in all. 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 Oct 2026.