HL-300 Ointment in Healthy Volunteers

NCT07684937 | Completed Phase 1

• 1 other identifier: HL-300-101
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (6)

• 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

  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

  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

  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

  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)

  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

  Single dose: Day 8; Multiple dose: Day7, Day14

Study Arms (4)

HL-300 Ointment 0.25% Group

OTHER

Strength:0.25%;Dosing Days:Day 1;Ointment Dosage and Administration:2.5g, 1600 cm²;

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;

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

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

Drug: HL-300

Interventions

HL-300 DRUG

Number of Healthy Volunteers:4 (Treatment group: 3, Placebo\*: 1)

Also known as: Placebo

HL-300 Ointment 0.25% Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Hangzhou Highlightll Pharmaceutical Co., Ltd: lead

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: July 6, 2026
• Study Start: June 14, 2024
• Primary Completion: November 25, 2024
• Study Completion: November 25, 2024
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share