This study is a Phase Ib/II clinical study. Phase 1b was a single-center, nonrandomized, single-arm study to evaluate the safety, PK profile, preliminary efficacy, and immunogenicity of different groups (SC) of CU-20401 in the submental fat accumulation population. Phase 2 is a multicenter, randomized, placebo parallel-controlled study to evaluate the safety, efficacy, and immunogenicity of the preferred group (SC) of CU-20401 in a submental fat accumulation population.
Eligible subjects will first enter Arm A1, receive treatment for this group on D1, and undergo study visits and biological sample collection (PK samples and immunogenicity samples) at established timepoints. After the last subject in Arm A1 has completed at least 3 days of safety and tolerability observation,After no safety events (≥ Grade 2 study drug-related AEs) have occurred as assessed by the investigator, enrollment into the A2 Arm may be initiated. Enrollment in subsequent treatment groups and so on. If a subject in this dose group experiences an AE ≥ Grade 2 related to the investigational product, the investigator will assess the time to continue observation and start the next treatment group according to the subject ' s condition. Based on the data obtained in Phase 1b, the grouping for Phase 2 will be determined by the investigator and the sponsor in consultation. It may be Group X1, Group X2, and Group X3. Eligible subjects were randomized 1: 1: 1: 1 to receive treatment in Group X1, X2, X3, or placebo on D1 and to undergo study visits and biological sample collection (immunogenicity samples) at established timepoints.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Subcutaneous injection in the subcutaneous fat area,0.2ml
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China
Occurrence of local skin reactions
Local skin reaction(LSR)such as erythema, edema, mild tenderness, bruising, pain, and tingling/burning sensation, and other adverse events. Local skin reactions (LSR) were assessed using a 4-point scale (0 = absent at all, 1 = mild, limited involvement, 2 = moderate involvement, 3 = severe, severe involvement).
Time frame: 1 month
Occurrence of other adverse events
such as abnormalities in laboratory tests, electrocardiograms, etc
Time frame: 1 month
Proportion of subjects with Submental Fat(SMF)Grade ≤ 1
Proportion of subjects with Submental Fat(SMF)Grade ≤ 1 assessed by the investigator using Clinician-Reported Submental Fat Rating Scale(CR-SMFRS),0=absent at all,1=mild,2=moderate,3=severe,4=very severe
Time frame: 1 month
Changes in SMF skin laxity compared to baseline
The investigator assessed the change from baseline in SMF skin relaxation using Submental Skin Relaxation Scale (SLRS).1=absent at all,2=mild,3=moderate,4=severe。
Time frame: 1 month
The proportion of subjects with SMF score ≥ 3 points
The proportion of subjects with SMF score ≥ 3 points was assessed by Subject Self-Rating Scale(SSRS), 0=very dissatisfied,1=dissatisfied,2=Generally satisfied,3=A little satisfied,4=very satisfied
Time frame: 1 month
Proportion of subjects with at least a 10% reduction from baseline in submental fat area
Proportion of subjects with at least a 10% reduction from baseline in submental fat area using MRI.
Time frame: 1 month
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Changes in overall aesthetics compared to baseline
Change from baseline in Global Aesthetic Improvement Scale (GAIS) score,1=Very noticeable improvement,2=noticeable improvement,3=A little improvement,4=No improvement,5=Even worse
Time frame: 1 month
Changes in SMF compared to baseline
The investigator assessed the change from baseline in SMF skin relaxation using Patient-Reported Submental Fat Rating Scale(PR-SMFRS),0= Fat free,1=a little fat,2=a moderate amount of fat,3=a lot of fat,4=very many fats
Time frame: 1 month