A Phase I Clinical Trial to Evaluate CU-10101 Unguent

NCT06744569 | Enrolling By Invitation Phase 1

• 1 other identifier: CU-10101-103
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The study was conducted in two parts:Part 1 and Part 2.Part 1 is a single-site,randomized,double-blind,vehicle-controlled single and multiple administration,dose-escalation study in healthy Chinese participants.There are four cohorts in Part 1.Part 2 is a randomized,double-blind,vehicle-controlled single and multiple administration,dose-escalation study in Chinese participants with mild to moderate atopic dermatitis.It is planned to be conduct in 1 to 3 sites,with a total of four cohorts in Part 2.

Conditions

Atopic Dermatitis

Keywords

CU-10101 unguent

Outcome Measures

Primary Outcomes (6)

• Adverse Events assessed by CTCAE V5.0

  The latest version of the Regulatory Activity Medical Dictionary (MedDRA) was used to encode AE terms used by investigators in eCRF. All adverse events (TEAE) that occurred during treatment were analyzed. TEAE will be summarized by dose grouping by systematic organ classification, preferred terminology and CTCAE classification, and relationship to investigational drug products.

  Part1:Day20；Part2:Day36

• Vital signs

  Summary changes in heart rate, blood pressure (systolic and diastolic), body temperature (frontal temperature), and respiratory rate, as well as relative baseline levels, were descriptively summarized at each planned time point. The changes of clinical significance before and after physical examination and treatment will be described.

  Part1: Day-7~Day-1，Day-1，Day1~Day13，Day20；Part2: Day-14~Day-2，Day-1，Day1，Day2，Day7, Day8，Day15, Day29，Day36

• 12-lead electrocardiogram

  Including PR interval, QRS interval, QT interval and QTc interval. To provide a descriptive summary of changes in ECG parameters relative to baseline by visit, and to provide a summary of changes in clinical significance of ECG parameters before and after treatment.

  Part1: Day-7~Day-1，Day-1，Day1~Day13，Day20；Part2: Day-14~Day-2，Day-1，Day1，Day2，Day7, Day8，Day15, Day29，Day36

• Laboratory examination

  The data of laboratory tests were summarized according to the type of laboratory tests, and the changes of laboratory test values at baseline and post-treatment planned time points and relative baseline levels were descriptively summarized, and the changes in clinical significance before and after treatment were provided.

  Part1: Day-7~Day-1，Day13，Day20；Part2: Day-14~Day-2，Day-1， Day8，Day15, Day29，Day36

• Skin tolerance assessment

  Descriptive summary of skin tolerances. Skin tolerance was assessed based on local irritant reactions (e.g. rash, redness, pain, etc.) to the participant's skin at the time points specified in the SoA. If the skin tolerance problems described above occur after a participant receives the study treatment and are assessed by the investigator as abnormal and clinically significant, an AE should be recorded and adverse event generics performed.Language Standards (CTCAE) v5.0 assessment criteria were used to assess their severity.

  Part1: Day1~Day20；Part2: Day1~Day36

• Physical examination

  This includes general examination, examination of the skin and mucous membranes, lymph nodes, head, neck, chest, abdomen, spine, and limbs, or other areas as needed.

  Part1: Day-7~Day-1，Day-1，Day1，Day4~Day9，Day10，Day13，Day20；Part2: Day-14~Day-2，Day-1，Day1，Day7, Day8，Day15, Day29，Day36

Study Arms (8)

Part1: cohort1

EXPERIMENTAL

BSA20%\_0.3% (10g:30mg)

Drug: CU-10101

Part1: cohort2

EXPERIMENTAL

BSA20%\_1%(10g:100mg)

Drug: CU-10101

Part1: cohort3

EXPERIMENTAL

BSA20%\_2%(10g:200mg)

Drug: CU-10101

Part1: cohort4

EXPERIMENTAL

BSA40%\_2%(10g:200mg)

Drug: CU-10101

Part2: cohort1

EXPERIMENTAL

QD\_0.3%(10g:30mg)

Drug: CU-10101

Part2: cohort2

EXPERIMENTAL

QD\_1%(10g:100mg)

Drug: CU-10101

Part2: cohort3

EXPERIMENTAL

QD\_2%(10g:200mg)

Drug: CU-10101

Part2: cohort4

EXPERIMENTAL

BID\_2%(10g:200mg) or BID\_1%(10g:100mg)

Drug: CU-10101

Interventions

CU-10101 DRUG

0.3%CU-10101 ；1%CU-10101 ；2%CU-10101； Placebo

Part1: cohort1; Part1: cohort2; Part1: cohort3; Part1: cohort4; Part2: cohort1; Part2: cohort2; Part2: cohort3; Part2: cohort4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Part 1：1.Subjects were 18-45 years of age (inclusive), male or female, at the time of signing the informed consent form;
• Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg; body mass index in the range of 18.0-27.0 kg/m2 (including cut-off);
• Based on physical examination, vital signs, electrocardiogram, and laboratory results, it was shown to be in good health without clinically significant abnormalities (as judged by the investigator);
• Ability to fully understand the contents of the study, voluntarily participate in the study, and sign the informed consent form. Follow protocol procedures to complete relevant visits during the study;
• Female participants of childbearing potential and male participants with partners of childbearing potential must consent from signing the informed consent form and no childbearing plan and voluntary use of appropriate contraception up to 3 months after the last dose.
• Part 2：1.Subjects were 18-65 years of age (inclusive), male or female, at the time of signing the informed consent form;
• Diagnosed with AD according to Hanifin-Rajka diagnostic criteria and a history of AD assessed by the investigator for ≥ 6 months;
• Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg; body mass index in the range of 18.0-27.0 kg/m2 (including cut-off);
• Investigator Global Assessment (IGA) score of 2 or 3 at screening and baseline;
• At screening and baseline, BSA was 5% -40% (excluding the area of lesions on the scalp, face, genitalia and intertriginous sites \[e.g., axillary, inguinal, elbow fossa, etc.\] when calculating the lesion area);
• Ability to fully understand the contents of the study, voluntarily participate in the study, and sign the informed consent form. Follow protocol procedures to complete relevant visits during the study;
• Female participants of childbearing potential and male participants with partners of childbearing potential must consent from signing the informed consent form and no childbearing plan and voluntary use of appropriate contraception up to 3 months after the last dose.

You may not qualify if:

• Part 1 ：1.Allergic constitution (e.g., allergy to two or more drugs, food and pollen), or allergy to the ingredients or excipients of the investigational medicinal product;
• Those who cannot tolerate venipuncture, or have a history of needle sickness and blood sickness;
• Subjects with skin damage, atopic dermatitis, eczema, rash, pigmentation and tattoos at the administration site, or other conditions judged by the investigator to be likely to affect drug absorption or affect skin tolerance;
• Previous or current significant or clinically significant diseases/abnormalities, including, but not limited to, heart/cardiocerebrovascular, respiratory, endocrine, gastrointestinal, kidney, liver, gallbladder, dermatological, hematological, immune, neurological or psychiatric diseases/abnormalities, or, as judged by the investigator, there is a safety risk or impact on safety, tolerability or pharmacokinetic assessment;
• Participants with a prior diagnosis of malignancy;
• Lactating women or women with positive pregnancy results, or women who plan to become pregnant during the study;
• Hepatitis C virus (HCV) antibody, hepatitis B surface antigen (HBsAg), treponema pallidum (TP) antibody, human immunodeficiency virus (HIV) antibody were positive;
• Those who smoke more than 5 cigarettes per day for 3 months prior to screening or cannot stop using any tobacco products during the study;
• Frequent drinkers within 3 months prior to screening, i.e., more than 14 units of alcohol per week (1 unit = 360 mL beer or 45 mL of spirits with 40% alcohol or 150 mL of wine) or who were unable to discontinue use of any alcoholic product during the study or had a positive alcohol breath test at screening;
• Previous history of drug abuse, drug use within 3 months prior to screening, or positive urine drug screen at screening;
• Donation of blood or massive blood loss (≥ 400 mL) within 3 months prior to screening;
• Participation in other clinical trials within 3 months prior to screening or during the study;
• Major surgery within 3 months prior to screening (major surgery is defined in accordance with the Medical Journal of Medicine, May 1, 2009 Grade 3 and 4 surgery specified in the Measures for the Administration of Clinical Application of Therapeutic Techniques), or who plan to undergo surgery during the study;
• Those who have received live (attenuated) vaccines within 4 weeks prior to screening, or plan to receive live (attenuated) vaccines during treatment and within 4 weeks after the last dose of investigational product;
• Received any other medication, including herbal and dietary supplements, within 2 weeks or 5 times the elimination half-life prior to screening, whichever is longer;

Sponsors & Collaborators

• Cutia Therapeutics（Wuxi）Co.,Ltd: lead

Study Sites (1)

Shanghai Skin Disease Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

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: August 9, 2024
• First Posted: December 20, 2024
• Study Start: September 12, 2024
• Primary Completion (Estimated): September 9, 2026
• Study Completion (Estimated): September 9, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)