Atopic DermatitisPhase 1NCT05932888
Safety, Tolerability, and Pharmacokinetic Study of QLM3003 in Healthy Adult Subjects
A Phase 1 study testing QLM3003 in people with Atopic Dermatitis, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) doses of QLM3003 compared to placebo. Also, pharmacokinetics (PK) of qlm3003 will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- QLM3003
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2023to 30 Aug 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult subjects between 18-55 years of age (inclusive), male or female
- The body mass index (BMI equal to body mass/square of body height) of the subjects ranges from 19 to 26 kg/m2 (inclusive), and males of weight not less than or equal to 50 kg, females of weight not less than or equal to 45 kg.
- Subjects have no sperm donation, egg donation plan, no pregnancy plan and voluntarily take effective contraceptive measures from 14 days before signing the informed consent form to 30 days after the last dose of investigational product;
- The subjects understand and comply with the study requirements, voluntarily participate in the study and sign the informed consent form.
Who cannot join
- Patients who are allergic to the investigational product or its preparation ingredients, or have previous allergic diseases, history of drug allergy, history of skin allergy, or known to be hypersensitive;
- Patients with clinically relevant skin diseases that are contraindicated in the study or affect the assessment of the administration site at screening, including but not limited to psoriasis, eczema, acne, atopic dermatitis, dysplastic mole, or other skin lesions, and a history of skin cancer;
- Skin conditions affecting the assessment of the study drug such as ulceration, injury, sunburn, redness and swelling, rash, or abnormal fever, tattoos, birthmarks, skin scars, skin perforations, skin infections on the skin of the target application area at screening and before administration, or disagreeing to removing the hair on the skin of this site;
- Pregnant or lactating women, and those who cannot use one or more non-drug contraceptive measures during the trial;
- Patients who have difficulty in collecting blood or cannot tolerate venipuncture, and have a history of fainting needle halo;
- Those who have special requirements for diet and cannot abide by the unified diet;
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- Excessive consumption of tea, coffee or caffeinated beverages, or consumption of grapefruit, or xanthine-rich foods or beverages within 14 days before screening, or inability to stop consumption of xanthine-rich foods or beverages, or grapefruit or pomelo and products containing grapefruit or pomelo ingredients within 48 hours before dosing and during the trial;
- Patients who smoked more than 5 cigarettes or the same amount of tobacco daily for 3 months before screening and could not stop using any tobacco products during the trial;
- Regular drinkers within 6 months before screening, i.e., those who drank more than 14 units of alcohol per week or could not stop using any alcohol-containing products during the trial; or those who took any alcohol-containing products within 48 hours before the first dose, or those who tested positive for alcohol breath before randomization;
- Drug abusers or those who have used soft drugs within 3 months before screening or hard drugs within 1 year before screening or those who have positive drug abuse screening before randomization;
- Blood donation or massive blood loss, receiving blood transfusion or using blood products within 3 months before screening;
- Any surgical procedure within 30 days prior to Screening or planned during the study and within 30 days after the end of the study;
- Patients who have received any live vaccines within 30 days before screening or need to receive live vaccines during the study;
- Use of any drug that inhibits or induces hepatic metabolism of the drug within 30 days before screening;
- Patients who have taken any drug or health product within 14 days before screening;
- Patients who have participated in and used any drug or medical device clinical trials within 3 months before screening, or within 5 half-lives of other investigational drugs before screening;
- Patients with previous serious or clinically significant diseases or abnormalities at screening, including but not limited to cardiovascular system, nervous system, respiratory system, blood and lymphatic system, digestive system, immune system, liver, kidney, metabolism and bone system diseases or psychiatric diseases or history of malignant tumors;
- Abnormal vital signs or clinically significant abnormalities in physical examination, ECG and laboratory tests (subject to the judgment of the clinical study physician);
- Patients with active tuberculosis suggested by clinical symptoms, signs, laboratory tests or chest radiography at screening;
- Patients whose white blood cell count, neutrophil count, lymphocyte count or hemoglobin in blood routine examination exceed the normal reference range and have clinical significance judged by the investigator;
- May increase study-related risks, may interfere with interpretation of study results, or, in the judgment of the investigator, make the investigator and/or sponsor unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site
The Third Xiangya Hospital of Central South University
Changsha, Hunan
About this study
Official title: A Single Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of QLM3003 in Healthy Adult Chinese Subjects
The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) doses of QLM3003 compared to placebo. Also, pharmacokinetics (PK) of qlm3003 will be evaluated.
Read the detailed description
The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) doses of QLM3003 compared to placebo. Also, pharmacokinetics (PK) of qlm3003 will be evaluated.Eligible subjects will be assigned to a sequential treatment cohort and randomized to each treatment group (active/placebo ). Subject enrollment will continue into the next cohort after review of the dose safety from the previous dose cohort.
- Conditions
- Atopic Dermatitis
- Being tested
- QLM3003, QLM3003 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.
QLM3003Drug
1%（10g∶0.1g）or 1.5%（10g∶0.15g）or 2%（10g∶0.2g）
QLM3003 PlaceboDrug
1%（10g∶0.1g）or 1.5%（10g∶0.15g）or 2%（10g∶0.2g）(matching corresponding study medication)
| Study group | Role | What they receive |
|---|---|---|
| QLM3003 | Experimental | QLM3003 Single dose Receives: Drug: QLM3003 |
| QLM3003 Placebo | Placebo comparator | QLM3003 vehicle Single dose Receives: Drug: QLM3003 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence (severity and causality) of any local and systemic adverse events
adverse events
Measured: 8 days
Secondary outcomes (3)
Maximum Plasma Concentration (Cmax) of QLM3003
Cmax
Measured: 8 days
Area Under the Plasma Concentration-Time Curve From 0 to t of QLM3003
AUC0-t
Measured: 8 days
Area Under the Plasma Concentration-Time Curve From 0 to infinity of QLM3003
AUC0-∞
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start25 Jun 2023
- Primary completion5 Aug 2023
- Study completion30 Aug 2023
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.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- guoping Yang, doctor, Study director, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932888
- Sponsor's protocol ID
- QLM3003-102
- Status last verified
- Sep 2023
- First submitted
- 22 Jun 2023
- Last updated
- 21 Sep 2023
- 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 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of QLM3003 in Healthy Adult Chinese Subjects
- ClinicalTrials.gov ID
- NCT05932888
- Acronym / sponsor ID
- QLM3003-102
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Jun 2023 (actual)
- Primary completion
- 5 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 6 Jul 2023 (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 purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) doses of QLM3003 compared to placebo. Also, pharmacokinetics (PK) of qlm3003 will be evaluated.
Detailed description
The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) doses of QLM3003 compared to placebo. Also, pharmacokinetics (PK) of qlm3003 will be evaluated.Eligible subjects will be assigned to a sequential treatment cohort and randomized to each treatment group (active/placebo ). Subject enrollment will continue into the next cohort after review of the dose safety from the previous dose cohort.
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 |
|---|---|---|
| QLM3003 | Experimental | Drug: QLM3003QLM3003 Single dose |
| QLM3003 Placebo | Placebo comparator | Drug: QLM3003 PlaceboQLM3003 vehicle Single dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adult subjects between 18-55 years of age (inclusive), male or female
- The body mass index (BMI equal to body mass/square of body height) of the subjects ranges from 19 to 26 kg/m2 (inclusive), and males of weight not less than or equal to 50 kg, females of weight not less than or equal to 45 kg.
- Subjects have no sperm donation, egg donation plan, no pregnancy plan and voluntarily take effective contraceptive measures from 14 days before signing the informed consent form to 30 days after the last dose of investigational product;
- The subjects understand and comply with the study requirements, voluntarily participate in the study and sign the informed consent form.
Key exclusion criteria (21 listed)
- Patients who are allergic to the investigational product or its preparation ingredients, or have previous allergic diseases, history of drug allergy, history of skin allergy, or known to be hypersensitive;
- Patients with clinically relevant skin diseases that are contraindicated in the study or affect the assessment of the administration site at screening, including but not limited to psoriasis, eczema, acne, atopic dermatitis, dysplastic mole, or other skin lesions, and a history of skin cancer;
- Skin conditions affecting the assessment of the study drug such as ulceration, injury, sunburn, redness and swelling, rash, or abnormal fever, tattoos, birthmarks, skin scars, skin perforations, skin infections on the skin of the target application area at screening and before administration, or disagreeing to removing the hair on the skin of this site;
- Pregnant or lactating women, and those who cannot use one or more non-drug contraceptive measures during the trial;
- Patients who have difficulty in collecting blood or cannot tolerate venipuncture, and have a history of fainting needle halo;
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 |
|---|---|---|
| QLM30031%（10g∶0.1g）or 1.5%（10g∶0.15g）or 2%（10g∶0.2g） | Drug | QLM3003 |
| QLM3003 Placebo1%（10g∶0.1g）or 1.5%（10g∶0.15g）or 2%（10g∶0.2g）(matching corresponding study medication) | Drug | QLM3003 Placebo |
Primary outcome
Incidence (severity and causality) of any local and systemic adverse events
Time frame: 8 days
adverse events
3 secondary outcomes
Maximum Plasma Concentration (Cmax) of QLM3003
Time frame: 8 days
Area Under the Plasma Concentration-Time Curve From 0 to t of QLM3003
Time frame: 8 days
Area Under the Plasma Concentration-Time Curve From 0 to infinity of QLM3003
Time frame: 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
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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. This study is not recruiting at the moment.
guoping Yang, doctor study director
The Third Xiangya Hospital of Central South University
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 QLM3003 in people with Atopic Dermatitis, run by Qilu Pharmaceutical 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 4 inclusion and 21 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: finished, as of the sponsor's last update on 21 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence (severity and causality) of any local and systemic adverse events (time frame: 8 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 21 Sep 2023.