CompletedPhase 1

HL-300 Ointment in Healthy Volunteers

36 participantsStarted 2024-06-14

Plain-language summary

To evaluate the safety and tolerability of HL-300 ointment following single and multiple topical administrations in healthy Chinese adult volunteers.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To evaluate the safety and tolerability of HL-300 ointment after single and multiple topical doses in healthy adult volunteers in China

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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.

Trial details

NCT IDNCT07684937

SponsorHangzhou Highlightll Pharmaceutical Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-25

View on ClinicalTrials.gov More Atopic Dermatitis trials

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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;

What they're measuring

To evaluate the safety and tolerability of HL-300 ointment after single and multiple topical doses in healthy adult volunteers in China

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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.