Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT06744569
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-11-20
First Post:
2024-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase I Clinical Trial to Evaluate CU-10101 Unguent
Sponsor:
Cutia Therapeutics（Wuxi）Co.,Ltd
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Vehicle-Controlled Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Preliminary Efficacy of CU-10101 Unguent in Healthy and AD Participants
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
Part 1:This is a randomized, double-blind, vehicle-controlled Phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetic profile of CU-10101 unguent after single and multiple doses in adult healthy subjects. The study consisted of screening, dosing, and end-of-study (EOS) visits.
Screening (D-7 to D-1): from 7 days before dosing (D-7) to 1 day prior to dosing (D-1), subjects will undergo screening-related examinations as required by this protocol after signing the informed consent form, and eligibility will be confirmed according to the inclusion/exclusion criteria. Eligible subjects will be admitted to the Phase I clinical trial site 1 day before dosing (D-1), relevant examinations will be performed as required by the protocol, and the inclusion/exclusion criteria will be confirmed again. Reconfirmed eligible subjects will remain in the study. Draw areas of skin that require drug application based on body maps .
Dosing period (D1-D13): Subjects will be randomized prior to dosing on D1 (each cohort will be randomized in a 2: 1 ratio to the investigational product or vehicle group) and CU-10101 unguent or vehicle will be evenly applied to the specified dose position on the morning of D1 and every morning (dosing interval is 24 h ± 0.5 h) from D4 to D10 based on randomization results. Subjects will collect PK blood samples at the time points specified in the protocol. Left the Phase 1 clinical site after completing blood sampling and relevant examinations on D13.
EOS Visit period (D20): Subjects will return to the Phase I clinical trial site for safety monitoring on D20 ± 1.
Part 2
This is a randomized, double-blind, vehicle-controlled Phase 1 clinical trial to evaluate the safety, tolerability, and pharmacokinetic profile of CU-10101 unguent after single and multiple doses in adult subjects with atopic dermatitis meanwhile exploring efficacy after multiple doses. The study consisted of screening, dosing, and end-of-study (EOS) visits.
Screening (D-14 to D-1): from 14 days before dosing (D-14) to 2 days prior to dosing (D-2), subjects will undergo screening-related examinations as required by this protocol after signing the informed consent form, and eligibility will be confirmed according to the inclusion/exclusion criteria. Eligible subjects will be admitted to the Phase I clinical trial site 1 day before dosing (D-1), relevant examinations will be performed as required by the protocol, and the inclusion/exclusion criteria will be confirmed again. Reconfirmed eligible subjects will remain in the study. Draw areas of skin that require drug application based on body maps .
Dosing period (D1-D29): sujects will be randomized prior to dosing on D1 (each cohort will be randomized in a 4: 1 ratio to the investigational product group or vehicle group) and CU-10101 unguent or vehicle will be evenly applied to the skin lesion sites every morning from D1 to D28 based on the randomization results (dosing will be completed by 12：00 noon daily for QD dosing group; dosing will be administered only once on D1 and D7 of BID groups, dosing interval is not less than 8 h). Given that CU-10101 is a high clearance compound, subjects will leave the Phase 1 clinical trial site after completing the single dose to continue multiple doses of CU-10101 unguent or vehicle at the same dose. After complete the relevant examinations and the investigator assesses that the requirements for continuation this trial are met the protocol at the Phase I clinical trial site on D1-D2 and D6-D8, the subjects will continue dosing until the last dose is completed on D28, and the subjects will continue dosing until the study is completed or the treatment discontinuation criteria are met. Subjects returned to the Phase I clinical trial site for safety monitoring and efficacy evaluation on D15 and D29. Safety monitoring included, but was not limited to, vital signs, physical examinations, 12-lead electrocardiograms (ECGs), laboratory examinations (hematology, blood biochemistry, urinalysis), and pregnancy examinations (D29 only), and AEs and concomitant medications. Efficacy evaluations included BSA, IGA score, EASI score, and NRS score. Subjects will collect PK blood samples at the time points. In addition, the skin areas requiring treatment will be redrawn prior to dosing on D8 and D15 and on D29 or the Early Withdrawal Visit.
EOS Visit Period (D36): subjects will return to the Phase I clinical trial site for safety monitoring on D36 ± 1.
Screening (D-7 to D-1): from 7 days before dosing (D-7) to 1 day prior to dosing (D-1), subjects will undergo screening-related examinations as required by this protocol after signing the informed consent form, and eligibility will be confirmed according to the inclusion/exclusion criteria. Eligible subjects will be admitted to the Phase I clinical trial site 1 day before dosing (D-1), relevant examinations will be performed as required by the protocol, and the inclusion/exclusion criteria will be confirmed again. Reconfirmed eligible subjects will remain in the study. Draw areas of skin that require drug application based on body maps .
Dosing period (D1-D13): Subjects will be randomized prior to dosing on D1 (each cohort will be randomized in a 2: 1 ratio to the investigational product or vehicle group) and CU-10101 unguent or vehicle will be evenly applied to the specified dose position on the morning of D1 and every morning (dosing interval is 24 h ± 0.5 h) from D4 to D10 based on randomization results. Subjects will collect PK blood samples at the time points specified in the protocol. Left the Phase 1 clinical site after completing blood sampling and relevant examinations on D13.
EOS Visit period (D20): Subjects will return to the Phase I clinical trial site for safety monitoring on D20 ± 1.
Part 2
This is a randomized, double-blind, vehicle-controlled Phase 1 clinical trial to evaluate the safety, tolerability, and pharmacokinetic profile of CU-10101 unguent after single and multiple doses in adult subjects with atopic dermatitis meanwhile exploring efficacy after multiple doses. The study consisted of screening, dosing, and end-of-study (EOS) visits.
Screening (D-14 to D-1): from 14 days before dosing (D-14) to 2 days prior to dosing (D-2), subjects will undergo screening-related examinations as required by this protocol after signing the informed consent form, and eligibility will be confirmed according to the inclusion/exclusion criteria. Eligible subjects will be admitted to the Phase I clinical trial site 1 day before dosing (D-1), relevant examinations will be performed as required by the protocol, and the inclusion/exclusion criteria will be confirmed again. Reconfirmed eligible subjects will remain in the study. Draw areas of skin that require drug application based on body maps .
Dosing period (D1-D29): sujects will be randomized prior to dosing on D1 (each cohort will be randomized in a 4: 1 ratio to the investigational product group or vehicle group) and CU-10101 unguent or vehicle will be evenly applied to the skin lesion sites every morning from D1 to D28 based on the randomization results (dosing will be completed by 12：00 noon daily for QD dosing group; dosing will be administered only once on D1 and D7 of BID groups, dosing interval is not less than 8 h). Given that CU-10101 is a high clearance compound, subjects will leave the Phase 1 clinical trial site after completing the single dose to continue multiple doses of CU-10101 unguent or vehicle at the same dose. After complete the relevant examinations and the investigator assesses that the requirements for continuation this trial are met the protocol at the Phase I clinical trial site on D1-D2 and D6-D8, the subjects will continue dosing until the last dose is completed on D28, and the subjects will continue dosing until the study is completed or the treatment discontinuation criteria are met. Subjects returned to the Phase I clinical trial site for safety monitoring and efficacy evaluation on D15 and D29. Safety monitoring included, but was not limited to, vital signs, physical examinations, 12-lead electrocardiograms (ECGs), laboratory examinations (hematology, blood biochemistry, urinalysis), and pregnancy examinations (D29 only), and AEs and concomitant medications. Efficacy evaluations included BSA, IGA score, EASI score, and NRS score. Subjects will collect PK blood samples at the time points. In addition, the skin areas requiring treatment will be redrawn prior to dosing on D8 and D15 and on D29 or the Early Withdrawal Visit.
EOS Visit Period (D36): subjects will return to the Phase I clinical trial site for safety monitoring on D36 ± 1.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: