Atopic DermatitisPhase 1NCT06946641
A Phase I Study of QLS12010 Capsules: Safety, Tolerability, PK, PD, and Food Effects in Healthy Adults and Moderate to Severe Atopic Dermatitis Patients
A Phase 1 study testing QLS12010 in people with Atopic Dermatitis and Hidradenitis Suppurativa (HS), run by Shanghai Qilu Pharmaceutical Research and Development Center LTD at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the safety, tolerability, PK, and PD of single and multiple ascending doses of QLS12010 Capsules and the effect of food on their PK profiles in healthy adult participants and participants with atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Hidradenitis Suppurativa (HS), Rheumatoid Arthritis (RA)
- What is being tested?
- QLS12010
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2025to Apr 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females aged 18-45 (inclusive),
- Weight: ≥ 50 kg for males and ≥ 45 kg for females, body mass index (BMI): 18.0-30.0 kg/m2 (inclusive),
- Female or male participants between the ages of 18 to 75 years of age.
- Chronic AD diagnosed by the criteria of Hannifin and Rajka that has been present for at least 6 Months before the Screening Visit.
- At screening and baseline: EASI score ≥ 16, vIGA-AD™ score ≥ 3, and BSA affected by AD ≥ 10%;
- The weekly mean score of PP NRS ≥ 4 prior to the first administration (with assessment results for at least 4 days during the week before the first administration [D-7 to D-1]);
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- As judged by the investigator, within 6 months prior to screening, the patient had an inadequate response to topical medication therapy.
- General Exclusion Criteria:
- Participants with diseases that should be excluded as judged by the investigator at screening, including but not limited to the nervous system, psychiatric system, cardiovascular system, blood and lymphatic system, immune system, respiratory system, digestive system, urinary system, metabolic and skeletal system disorders,
- The 12-lead ECG at screening shows QTcF (QT corrected using Fridericia's formula) > 450 ms. If QTcF is > 450 ms, the 12-lead ECG should be repeated 2 more times (at least 3 min apart), and the mean of the 3 measurements will be used to determine whether the participant meets the inclusion criteria,
- Participants who smoke more than 5 cigarettes per day on average within 6 months before screening or are currently using e-cigarettes,
- Participants who consume more than 14 units of alcohol per week (1 unit = 360 mL of beer, 45 mL of 40% spirits, or 150 mL of wine) within 6 months before screening or have a positive breath alcohol test at screening,
- Participants who have donated more than 400 mL of blood within 3 months or more than 200 mL of blood within 4 weeks before screening, or plan to donate blood during the study,
- Participants who have received any strong inhibitor or inducer of CYP3A4 within 4 weeks before screening,
- Participants who have received any prescription drugs, OTC drugs, traditional medicines, and dietary supplements within 2 weeks before the first dose or 5 half-lives (whichever is longer).
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Who cannot join
None listed.
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
Peking University Third Hospital
Beijing
Haiyan Li, M.D., (+86) 18600489179, haiyanli1027@hotmail.com
Wenhui Wang, M.D., (+86) 15611908751
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effects of Single and Multiple Ascending Doses of QLS12010 Capsules in Healthy Adult Participants and Participants With Atopic Dermatitis
The goal of this clinical trial is to evaluate the safety, tolerability, PK, and PD of single and multiple ascending doses of QLS12010 Capsules and the effect of food on their PK profiles in healthy adult participants and participants with atopic dermatitis. This study consists of four parts: Part A is a single ascending dose (SAD) study, once sufficient safety and PK data are obtained from the SAD cohorts, the SMC will determine the dosage of initial cohort in Part B, which consists of three multiple ascending doses (MAD) cohorts of QLS12010 Capsules. Part C is a randomized, open-label, two-cycle, crossover food effect study under fasting and fed (high-fat meal) conditions. Part D is to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) characteristics, and preliminary efficacy of QLS12010 Capsules following multiple oral administrations in adult participants with atopic dermatitis (AD).
- Being tested
- QLS12010, Placebo
- Medical subject headings
- Dermatitis, Atopic, Hidradenitis Suppurativa, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS12010Drug
QLS12010 oral capsule(s)
PlaceboDrug
Matching placebo oral capsule(s)
| Study group | Role | What they receive |
|---|---|---|
| Single ascending dose cohorts in healthy participants | Experimental | Healthy volunteer subject cohorts randomized 6:2 receiving a single dose of QLS12010 or placebo. The starting dose will be 25 mg of QLS12010 or placebo. Receives: Drug: QLS12010; Drug: Placebo |
| Multiple ascending dose cohorts in healthy subjects | Experimental | Healthy volunteer subject cohorts randomized 8:2 to receive QLS12010 or placebo QD for 14 continuous days. The starting dose of QLS12010 or placebo is based on upcoming data from SAD part. Receives: Drug: QLS12010; Drug: Placebo |
| Food Effect Cohort in healthy subjects | Experimental | Part C is a two-cycle, crossover study under fasting and fed (high-fat meal) conditions. In Cycle 1, 12 healthy adult participants will be randomly divided into two groups on D-1, with 6 participants in each group receiving a single oral dose of QLS12010 Capsules under fasting or fed conditions, respectively. After completing washout, they will receive crossover administration for the Cycle 2 study. Receives: Drug: QLS12010 |
| Early Efficacy in patients with AD | Experimental | Part D of the study plans to enroll 12 adults with moderate to severe atopic dermatitis (AD). Eligible subjects (after screening) will be sequentially assigned to two dose groups (Dose 1 and Dose 2) in the order of their enrollment. Enrollment of Dose 2 may commence only after Dose 1 has completed enrollment of 6 subjects. Receives: Drug: QLS12010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment emergent Adverse Events as assessed by CTCAE v5.0
Measured: up to approximately 1 month
Secondary outcomes (12)
Area under the curve plasma concentration from time zero to last measurable concentration [AUC(0-last)]
Measured: up to approximately 1 month
Area under the curve plasma concentration from time zero to infinity [AUC(0-∞)]
Measured: up to approximately 14 days
Maximum observed plasma concentration (Cmax)
Measured: up to approximately 1 month
Time to maximum observed plasma concentration (Tmax)
Measured: up to approximately 1 month
Terminal elimination half-life (t1/2)
Measured: up to approximately 1 month
Apparent clearance (CL/F)
Measured: up to approximately 1 month
Apparent volume of distribution (Vz/F)
Measured: up to approximately 1 month
Mean residence time (MRT)
Measured: up to approximately 1 month
Changes and percentage changes from baseline in Eczema Area and Severity Index (EASI) scores
The minimum EASI score is 0, and the maximum EASI score is 72. A score of 0 indicates clear or no eczema; a greater score indicates more severe disease.
Measured: at Weeks 1, 2, 3, 4, 5, and 6
Changes and percentage changes from baseline in Investigator's Global Assessment (IGA) scale
The IGA5-point scale ranges from 0 (clear) to 4 (severe AD). A decrease in score indicates an improvement in signs and symptoms.
Measured: at Weeks 1, 2, 3, 4, 5, and 6
Changes and percentage changes from baseline in weekly mean scores of Peak Pruritus Numerical Rating Scale (PP NRS)
The PP NRS is a single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 h based on the following question: 'On a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".
Measured: at Weeks 1, 2, 3, 4, 5, and 6
Changes and percentage changes from baseline of body surface area (BSA) affected by lesions
BSA assessment estimates the area of skin lesions in each part of the body, with one palm unit of the patient taken as 1% of the body surface area.
Measured: at Weeks 1, 2, 3, 4, 5, and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start31 Mar 2025
- Primary completionDec 2025 (estimated)
- Study completionApr 2026 (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
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Qilu Pharmaceutical Research and Development Center LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946641
- Sponsor's protocol ID
- QLS12010-101
- Status last verified
- Jul 2025
- First submitted
- 30 Mar 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effects of Single and Multiple Ascending Doses of QLS12010 Capsules in Healthy Adult Participants and Participants With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06946641
- Acronym / sponsor ID
- QLS12010-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Shanghai Qilu Pharmaceutical Research and Development Center LTDIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 27 Apr 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 clinical trial is to evaluate the safety, tolerability, PK, and PD of single and multiple ascending doses of QLS12010 Capsules and the effect of food on their PK profiles in healthy adult participants and participants with atopic dermatitis. This study consists of four parts: Part A is a single ascending dose (SAD) study, once sufficient safety and PK data are obtained from the SAD cohorts, the SMC will determine the dosage of initial cohort in Part B, which consists of three multiple ascending doses (MAD) cohorts of QLS12010 Capsules. Part C is a randomized, open-label, two-cycle, crossover food effect study under fasting and fed (high-fat meal) conditions. Part D is to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) characteristics, and preliminary efficacy of QLS12010 Capsules following multiple oral administrations in adult participants with atopic dermatitis (AD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single ascending dose cohorts in healthy participants | Experimental | Drug: QLS12010, Drug: PlaceboHealthy volunteer subject cohorts randomized 6:2 receiving a single dose of QLS12010 or placebo. The starting dose will be 25 mg of QLS12010 or placebo. |
| Multiple ascending dose cohorts in healthy subjects | Experimental | Drug: QLS12010, Drug: PlaceboHealthy volunteer subject cohorts randomized 8:2 to receive QLS12010 or placebo QD for 14 continuous days. The starting dose of QLS12010 or placebo is based on upcoming data from SAD part. |
| Food Effect Cohort in healthy subjects | Experimental | Drug: QLS12010Part C is a two-cycle, crossover study under fasting and fed (high-fat meal) conditions. In Cycle 1, 12 healthy adult participants will be randomly divided into two groups on D-1, with 6 participants in each group receiving a single oral dose of QLS12010 Capsules under fasting or fed conditions, respectively. After completing washout, they will receive crossover administration for the Cycle 2 study. |
| Early Efficacy in patients with AD | Experimental | Drug: QLS12010Part D of the study plans to enroll 12 adults with moderate to severe atopic dermatitis (AD). Eligible subjects (after screening) will be sequentially assigned to two dose groups (Dose 1 and Dose 2) in the order of their enrollment. Enrollment of Dose 2 may commence only after Dose 1 has completed enrollment of 6 subjects. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Males and females aged 18-45 (inclusive),
- Weight: ≥ 50 kg for males and ≥ 45 kg for females, body mass index (BMI): 18.0-30.0 kg/m2 (inclusive),
- Female or male participants between the ages of 18 to 75 years of age.
- Chronic AD diagnosed by the criteria of Hannifin and Rajka that has been present for at least 6 Months before the Screening Visit.
- At screening and baseline: EASI score ≥ 16, vIGA-AD™ score ≥ 3, and BSA affected by AD ≥ 10%;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| QLS12010QLS12010 oral capsule(s) | Drug | Early Efficacy in patients with AD, Food Effect Cohort in healthy subjects, Multiple ascending dose cohorts in healthy subjects, Single ascending dose cohorts in healthy participants |
| PlaceboMatching placebo oral capsule(s) | Drug | Multiple ascending dose cohorts in healthy subjects, Single ascending dose cohorts in healthy participants |
Primary outcome
Incidence and severity of treatment emergent Adverse Events as assessed by CTCAE v5.0
Time frame: up to approximately 1 month
12 secondary outcomes
Area under the curve plasma concentration from time zero to last measurable concentration [AUC(0-last)]
Time frame: up to approximately 1 month
Area under the curve plasma concentration from time zero to infinity [AUC(0-∞)]
Time frame: up to approximately 14 days
Maximum observed plasma concentration (Cmax)
Time frame: up to approximately 1 month
Time to maximum observed plasma concentration (Tmax)
Time frame: up to approximately 1 month
Terminal elimination half-life (t1/2)
Time frame: up to approximately 1 month
Apparent clearance (CL/F)
Time frame: up to approximately 1 month
Apparent volume of distribution (Vz/F)
Time frame: up to approximately 1 month
Mean residence time (MRT)
Time frame: up to approximately 1 month
Changes and percentage changes from baseline in Eczema Area and Severity Index (EASI) scores
Time frame: at Weeks 1, 2, 3, 4, 5, and 6
Changes and percentage changes from baseline in Investigator's Global Assessment (IGA) scale
Time frame: at Weeks 1, 2, 3, 4, 5, and 6
Changes and percentage changes from baseline in weekly mean scores of Peak Pruritus Numerical Rating Scale (PP NRS)
Time frame: at Weeks 1, 2, 3, 4, 5, and 6
Changes and percentage changes from baseline of body surface area (BSA) affected by lesions
Time frame: at Weeks 1, 2, 3, 4, 5, and 6
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 31 Jul 2025.
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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.
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 QLS12010 in people with Atopic Dermatitis and Hidradenitis Suppurativa (HS), run by Shanghai Qilu Pharmaceutical Research and Development Center 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 16 inclusion and 0 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 31 Jul 2025. 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. 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 Haiyan Li, M.D. ((+86) 18600489179, haiyanli1027@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment emergent Adverse Events as assessed by CTCAE v5.0 (time frame: up to approximately 1 month). 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 31 Jul 2025.