Atopic DermatitisPhase 1NCT07684937
HL-300 Ointment in Healthy Volunteers
A Phase 1 study testing HL-300 in people with Atopic Dermatitis, run by Hangzhou Highlightll Pharmaceutical Co., Ltd.
Trial summary
To evaluate the safety and tolerability of HL-300 ointment following single and multiple topical administrations in healthy Chinese adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- HL-300
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 14 Jun 2024to 25 Nov 2024
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female volunteers aged ≥ 18 and ≤ 45 years
- Males weighing ≥ 50 kg and females weighing ≥ 45 kg, with a body mass index (BMI) within the range of 19.0 to 26.0 kg/m² (inclusive), where BMI = weight (kg) / height² (m²);
- Women of childbearing potential (WOCBP) must confirm that they are not pregnant or lactating, and may only enter the study after a pregnancy test (e.g., based on HCG beta-subunit testing) is performed (the date of the last menstrual period must be recorded);
- Volunteers and their partners must voluntarily adopt effective contraceptive measures for at least 6 months after the administration of the investigational product; volunteers must have no plans to donate sperm or eggs for at least 6 months from the screening period to after administration;
- Volunteers must understand the informed consent form, voluntarily participate in the study, and sign the informed consent form; the informed consent form must be signed prior to the initiation of any study procedures.
Who cannot join
- Individuals with a history of malignant tumors, or any clinically severe disease (past or present) involving the circulatory, endocrine, nervous, digestive, respiratory, genitourinary, hematological, immunological, psychiatric systems, or metabolic disorders, or any other disease that may interfere with the study results;
- Volunteers who, in the opinion of the investigator, have clinically relevant skin diseases that are contraindicated for the study or may interfere with the assessment of the administration site, including psoriasis, eczema, acne, atopic dermatitis, dysplastic nevi, other skin lesions, or a history of skin cancer;
- Individuals with a history of active tuberculosis, a history of frequent infections within 1 year prior to screening, or a history of recurrent viral infections (such as recurrent oral herpes, genital herpes, or herpes zoster) within 3 months prior to administration; those who have experienced an infection deemed clinically significant by the investigator within 1 month prior to screening, including acute or chronic infections such as local infections (abscesses, furuncles, carbuncles, etc.), respiratory tract infections, genitourinary tract infections, or systemic infections;
- Individuals suspected of being allergic to the investigational drug or any of its components, or with a history of allergic diseases (e.g., allergic rhinitis, allergic asthma, etc.), drug allergy history, skin allergy history (including but not limited to allergies to adhesive patches, or contact dermatitis to metals, cosmetics, or household products), or those known to have an atopic constitution, such as a history of allergy to two or more drugs and foods.
- Those with vital signs (systolic blood pressure <90 mmHg or >140 mmHg, diastolic blood pressure <50 mmHg or >90 mmHg; heart rate <50 bpm or >100 bpm) or abnormalities in physical examination, electrocardiogram (ECG), chest X-ray, or laboratory tests that are clinically significant (as determined by the clinical research physician);
- Those whose white blood cell count, neutrophil count, lymphocyte count, or hemoglobin in the routine blood test are outside the normal reference range and are deemed clinically significant by the investigator;
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- ALT > 1.5 times the upper limit of normal (ULN), or AST > 1.5 times ULN, or total bilirubin > 1.5 times ULN;
- Those with positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus (HIV) antibody, or Treponema pallidum antibody (TP-Ab);
- Those with a positive dermatographia (skin scratch) test;
About this study
Official title: A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HL-300 Ointment After Single and Multiple Doses in Healthy Adult Volunteers
To evaluate the safety and tolerability of HL-300 ointment following single and multiple topical administrations in healthy Chinese adult volunteers.
Read the detailed description
This study is a single-center, randomized, double-blind, placebo-controlled, single and multiple ascending dose Phase I clinical study in healthy volunteers. A total of 36 volunteers are planned to be enrolled, with 4 in Cohort 1, 8 in Cohort 2, and 12 in each of Cohort 3 and Cohort 4.
In the single ascending dose (SAD) part (Cohorts 1-3), volunteers in each cohort will receive a single dose on Day 1 (D1). Blood samples will be collected from the volunteers at the time points specified in the protocol, and volunteers will be discharged after completing the final blood collection on D8. The blood sampling timepoints for subsequent dose cohorts may be adjusted based on the results of the preceding cohorts.
In the multiple ascending dose (MAD) part (Cohort 4), volunteers will apply the study drug twice daily from D1 to D7 (the dosing frequency during the MAD period may be appropriately adjusted based on the PK characteristics of the single dose). Blood sampling timepoints will be adjusted based on the dosing results, and volunteers will be discharged to enter the safety follow-up period after completing the final blood collection.
Volunteers in different dose cohorts will be enrolled sequentially, and the next cohort will only proceed provided that the 7-day tolerability evaluation of the preceding cohort indicates safety and tolerability. Whether to add subsequent dose cohorts will be determined based on the results obtained from the completed dose cohorts.
- Conditions
- Atopic Dermatitis
- Being tested
- HL-300
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HL-300Drug
Also called Placebo
Number of Healthy Volunteers:4 (Treatment group: 3, Placebo*: 1)
HL-300Drug
Also called Placebo
Number of Healthy Volunteers:8 (Treatment group: 6, Placebo: 2);Dosing Days:Day 1;
HL-300Drug
Also called Placebo
Number of Healthy Volunteers:12 (Treatment group: 10, Placebo: 2);Dosing Days:Day 1
HL-300Drug
Also called Placebo
Number of Healthy Volunteers:12 (Treatment group: 10, Placebo: 2);Dosing Days:Day 1-Day 7, BID;
| Study group | Role | What they receive |
|---|---|---|
| HL-300 Ointment 0.25% Group | Other | Strength:0.25%;Dosing Days:Day 1;Ointment Dosage and Administration:2.5g, 1600 cm²; Receives: Drug: HL-300 |
| HL-300 Ointment 0.5% Group | Other | Strength:0.5%;Number of Healthy Volunteers:8 (Treatment group: 6, Placebo: 2);Dosing Days:Day 1;Ointment Dosage and Administration:5g, 3200 cm²; Receives: Drug: HL-300 |
| HL-300 Ointment 1% Group | Other | Strength:1.0%;Number of Healthy Volunteers:12 (Treatment group: 10, Placebo: 2);Dosing Days:Day 1;Ointment Dosage and Administration:5g, 3200 cm² Receives: Drug: HL-300 |
| HL-300 Ointment 1% BID Group | Other | Strength:1.0%;Number of Healthy Volunteers:12 (Treatment group: 10, Placebo: 2);Dosing Days:Day 1-Day 7, BID;Ointment Dosage and Administration:5g, 3200 cm² Receives: Drug: HL-300 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of HL-300 ointment after single and multiple topical doses in healthy adult volunteers in China
Change from Baseline in Complete Blood Count
Measured: Single dose: Day3 Day 8;Multiple dose: Day7 Day14
To evaluate the safety and tolerability of HL-300 ointment after single and multiple topical doses in healthy adult volunteers in China
Change from Baseline in Blood Biochemistry
Measured: Single dose：Day3 Day 8;Multiple dose: Day7 Day14
To evaluate the safety and tolerability of HL-300 ointment after single and multiple topical doses in healthy adult volunteers in China
Change from Baseline in Coagulation Function
Measured: Single dose：Day3, Day 8;Multiple dose: Day3, Day5, Day7, Day9, Day11, Day14
To evaluate the safety and tolerability of HL-300 ointment after single and multiple topical doses in healthy adult volunteers in China
Change from Baseline in Urinalysis
Measured: Single dose：Day3 Day 8;Multiple dose: Day7 Day14
To evaluate the safety and tolerability of HL-300 ointment after single and multiple topical doses in healthy adult volunteers in China
Change from Baseline in U12-Lead Electrocardiogram (ECG)
Measured: Single-dose: Pre-dose Day1,post-dose Day1-12hour , Day2, Day3, Day8. Multiple-dose: Pre-dose Day1, Day4, Day7,post-dose Day1-12hour , Day7-12hour, Day10, Day14.
To evaluate the safety and tolerability of HL-300 ointment after single and multiple topical doses in healthy adult volunteers in China
Change from Baseline in Physical Examination
Measured: Single dose: Day 8; Multiple dose: Day7, Day14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start14 Jun 2024
- Primary completion25 Nov 2024
- Study completion25 Nov 2024
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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Highlightll Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684937
- Sponsor's protocol ID
- HL-300-101
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 6 Jul 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 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HL-300 Ointment After Single and Multiple Doses in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT07684937
- Acronym / sponsor ID
- HL-300-101
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hangzhou Highlightll Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 6 Jul 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.
To evaluate the safety and tolerability of HL-300 ointment following single and multiple topical administrations in healthy Chinese adult volunteers.
Detailed description
This study is a single-center, randomized, double-blind, placebo-controlled, single and multiple ascending dose Phase I clinical study in healthy volunteers. A total of 36 volunteers are planned to be enrolled, with 4 in Cohort 1, 8 in Cohort 2, and 12 in each of Cohort 3 and Cohort 4.
In the single ascending dose (SAD) part (Cohorts 1-3), volunteers in each cohort will receive a single dose on Day 1 (D1). Blood samples will be collected from the volunteers at the time points specified in the protocol, and volunteers will be discharged after completing the final blood collection on D8. The blood sampling timepoints for subsequent dose cohorts may be adjusted based on the results of the preceding cohorts.
In the multiple ascending dose (MAD) part (Cohort 4), volunteers will apply the study drug twice daily from D1 to D7 (the dosing frequency during the MAD period may be appropriately adjusted based on the PK characteristics of the single dose). Blood sampling timepoints will be adjusted based on the dosing results, and volunteers will be discharged to enter the safety follow-up period after completing the final blood collection.
Volunteers in different dose cohorts will be enrolled sequentially, and the next cohort will only proceed provided that the 7-day tolerability evaluation of the preceding cohort indicates safety and tolerability. Whether to add subsequent dose cohorts will be determined based on the results obtained from the completed dose cohorts.
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 |
|---|---|---|
| HL-300 Ointment 0.25% Group | Other | Drug: HL-300Strength:0.25%;Dosing Days:Day 1;Ointment Dosage and Administration:2.5g, 1600 cm²; |
| HL-300 Ointment 0.5% Group | Other | Drug: HL-300Strength:0.5%;Number of Healthy Volunteers:8 (Treatment group: 6, Placebo: 2);Dosing Days:Day 1;Ointment Dosage and Administration:5g, 3200 cm²; |
| HL-300 Ointment 1% Group | Other | Drug: HL-300Strength:1.0%;Number of Healthy Volunteers:12 (Treatment group: 10, Placebo: 2);Dosing Days:Day 1;Ointment Dosage and Administration:5g, 3200 cm² |
| HL-300 Ointment 1% BID Group | Other | Drug: HL-300Strength:1.0%;Number of Healthy Volunteers:12 (Treatment group: 10, Placebo: 2);Dosing Days:Day 1-Day 7, BID;Ointment Dosage and Administration:5g, 3200 cm² |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female volunteers aged ≥ 18 and ≤ 45 years
- Males weighing ≥ 50 kg and females weighing ≥ 45 kg, with a body mass index (BMI) within the range of 19.0 to 26.0 kg/m² (inclusive), where BMI = weight (kg) / height² (m²);
- Women of childbearing potential (WOCBP) must confirm that they are not pregnant or lactating, and may only enter the study after a pregnancy test (e.g., based on HCG beta-subunit testing) is performed (the date of the last menstrual period must be recorded);
- Volunteers and their partners must voluntarily adopt effective contraceptive measures for at least 6 months after the administration of the investigational product; volunteers must have no plans to donate sperm or eggs for at least 6 months from the screening period to after administration;
- Volunteers must understand the informed consent form, voluntarily participate in the study, and sign the informed consent form; the informed consent form must be signed prior to the initiation of any study procedures.
Key exclusion criteria (9 listed)
- Individuals with a history of malignant tumors, or any clinically severe disease (past or present) involving the circulatory, endocrine, nervous, digestive, respiratory, genitourinary, hematological, immunological, psychiatric systems, or metabolic disorders, or any other disease that may interfere with the study results;
- Volunteers who, in the opinion of the investigator, have clinically relevant skin diseases that are contraindicated for the study or may interfere with the assessment of the administration site, including psoriasis, eczema, acne, atopic dermatitis, dysplastic nevi, other skin lesions, or a history of skin cancer;
- Individuals with a history of active tuberculosis, a history of frequent infections within 1 year prior to screening, or a history of recurrent viral infections (such as recurrent oral herpes, genital herpes, or herpes zoster) within 3 months prior to administration; those who have experienced an infection deemed clinically significant by the investigator within 1 month prior to screening, including acute or chronic infections such as local infections (abscesses, furuncles, carbuncles, etc.), respiratory tract infections, genitourinary tract infections, or systemic infections;
- Individuals suspected of being allergic to the investigational drug or any of its components, or with a history of allergic diseases (e.g., allergic rhinitis, allergic asthma, etc.), drug allergy history, skin allergy history (including but not limited to allergies to adhesive patches, or contact dermatitis to metals, cosmetics, or household products), or those known to have an atopic constitution, such as a history of allergy to two or more drugs and foods.
- Those with vital signs (systolic blood pressure <90 mmHg or >140 mmHg, diastolic blood pressure <50 mmHg or >90 mmHg; heart rate <50 bpm or >100 bpm) or abnormalities in physical examination, electrocardiogram (ECG), chest X-ray, or laboratory tests that are clinically significant (as determined by the clinical research physician);
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 |
|---|---|---|
| HL-300Also: PlaceboNumber of Healthy Volunteers:4 (Treatment group: 3, Placebo*: 1) | Drug | HL-300 Ointment 0.25% Group |
| HL-300Also: PlaceboNumber of Healthy Volunteers:8 (Treatment group: 6, Placebo: 2);Dosing Days:Day 1; | Drug | HL-300 Ointment 0.5% Group |
| HL-300Also: PlaceboNumber of Healthy Volunteers:12 (Treatment group: 10, Placebo: 2);Dosing Days:Day 1 | Drug | HL-300 Ointment 1% Group |
| HL-300Also: PlaceboNumber of Healthy Volunteers:12 (Treatment group: 10, Placebo: 2);Dosing Days:Day 1-Day 7, BID; | Drug | HL-300 Ointment 1% BID Group |
Primary outcome
To evaluate the safety and tolerability of HL-300 ointment after single and multiple topical doses in healthy adult volunteers in China
Time frame: Single dose: Day3 Day 8;Multiple dose: Day7 Day14
Change from Baseline in Complete Blood Count
To evaluate the safety and tolerability of HL-300 ointment after single and multiple topical doses in healthy adult volunteers in China
Time frame: Single dose：Day3 Day 8;Multiple dose: Day7 Day14
Change from Baseline in Blood Biochemistry
To evaluate the safety and tolerability of HL-300 ointment after single and multiple topical doses in healthy adult volunteers in China
Time frame: Single dose：Day3, Day 8;Multiple dose: Day3, Day5, Day7, Day9, Day11, Day14
Change from Baseline in Coagulation Function
To evaluate the safety and tolerability of HL-300 ointment after single and multiple topical doses in healthy adult volunteers in China
Time frame: Single dose：Day3 Day 8;Multiple dose: Day7 Day14
Change from Baseline in Urinalysis
To evaluate the safety and tolerability of HL-300 ointment after single and multiple topical doses in healthy adult volunteers in China
Time frame: Single-dose: Pre-dose Day1,post-dose Day1-12hour , Day2, Day3, Day8. Multiple-dose: Pre-dose Day1, Day4, Day7,post-dose Day1-12hour , Day7-12hour, Day10, Day14.
Change from Baseline in U12-Lead Electrocardiogram (ECG)
To evaluate the safety and tolerability of HL-300 ointment after single and multiple topical doses in healthy adult volunteers in China
Time frame: Single dose: Day 8; Multiple dose: Day7, Day14
Change from Baseline in Physical Examination
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 6 Jul 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HL-300 in people with Atopic Dermatitis, run by Hangzhou Highlightll Pharmaceutical Co., Ltd.
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 9 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 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
To evaluate the safety and tolerability of HL-300 ointment after single and multiple topical doses in healthy adult volunteers in China (time frame: Single dose: Day3 Day 8;Multiple dose: Day7 Day14). The study lists 6 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 6 Jul 2026.