A Clinical Study to Evaluate the Safety, Pharmacokinetic Profile and Efficacy of CU-20401

NCT05195541 | Completed Phase 1

• 1 other identifier: CU-20401-104
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Safety

Keywords

pharmacokinetic profile; efficacy

Outcome Measures

Primary Outcomes (2)

• 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).

  1 month

• Occurrence of other adverse events

  such as abnormalities in laboratory tests, electrocardiograms, etc

  1 month

Secondary Outcomes (6)

• Proportion of subjects with Submental Fat（SMF）Grade ≤ 1

  1 month

• Changes in SMF skin laxity compared to baseline

  1 month

• The proportion of subjects with SMF score ≥ 3 points

  1 month

• Proportion of subjects with at least a 10% reduction from baseline in submental fat area

  1 month

• Changes in overall aesthetics compared to baseline

  1 month

Study Arms (10)

Cohort A1

EXPERIMENTAL

0.02mg/injection，2 injections

Drug: CU-20401

Cohort A2

EXPERIMENTAL

0.04mg/injection，2 injections

Drug: CU-20401

Cohort B1

EXPERIMENTAL

0.04mg/injection，4 injections

Drug: CU-20401

Cohort B2

EXPERIMENTAL

0.075mg/injection，4 injections

Drug: CU-20401

Cohort C1

EXPERIMENTAL

0.075mg/injection，6 injections

Drug: CU-20401

Cohort C2

EXPERIMENTAL

0.15mg/injection，6 injections

Drug: CU-20401

cohort X1

EXPERIMENTAL

0.04mg/injection，20 injections

Drug: CU-20401

cohort X2

EXPERIMENTAL

0.075mg/injection，20 injections

Drug: CU-20401

cohort X3

EXPERIMENTAL

0.15mg/injection，20 injections

Drug: CU-20401

cohort X

PLACEBO COMPARATOR

0.15mg of placebo /injection，20 injections

Drug: CU-20401

Interventions

CU-20401 DRUG

Subcutaneous injection in the subcutaneous fat area，0.2ml

Also known as: injection，CU-20401

Cohort A1; Cohort A2; Cohort B1; Cohort B2; Cohort C1; Cohort C2; cohort X; cohort X1; cohort X2; cohort X3

Eligibility Criteria

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

You may qualify if:

• Fully understand the trial contents, study process and possible adverse reactions, be able to complete the study in accordance with the protocol requirements, have reasonable expectations for the cosmetic effect of injection, and voluntarily sign the informed consent form;
• Men or women aged 18 to 65 years (including boundary values) at screening;
• Body mass index (BMI) was in the range of 17-40 (kg/m2) (including cut-off value) at screening;
• At screening, the investigator assessed moderate to severe submental outline protrusion due to submental fat accumulation according to the clinician-reported Submental Fat Rating Scale (CR-SMFRS) (see Annex 1), i.e., those with a score of 2 to 3 points;
• Non-pregnant and lactating women, and subjects (including males and females) have no pregnancy plan and voluntarily take effective contraceptive measures at screening and throughout the trial, and have no sperm or egg donation plans.

You may not qualify if:

• Subjects who have received prior surgery, liposuction therapy, or injection of lipolytic drugs similar to the investigational drug (e.g., phosphatidylcholine, etc.) at the submental site;
• Those who have received biomaterial fillings (e.g., hyaluronic acid, collagen, etc.) in the neck or chin before screening;
• Those who have received botulinum toxin injection in the neck or submental area within 3 months prior to screening, or have received noninvasive skin tightening therapy;
• Planned to undergo cosmetic procedures at the submental site during the study, including, but not limited to, dermal filling, surgical wrinkle removal, photoelectric therapy, water light needles, microneedles, chemical peeling, or scar removal surgery, etc.;
• Enlargement of the submental area due to other causes of excess non-submental fat accumulation (e.g., goiter, lymphadenopathy, Madelong's disease, platysma protrusion at rest, etc.) or affect the investigator's assessment of submental fat;
• Those with obvious scars, infections, cancerous or precancerous lesions and/or unresolved wounds, retrognathia, etc. in the chin and neck position, which may affect the evaluation results as assessed by the investigator;
• According to the investigator's judgment, submental fat dissolution can cause submental skin relaxation (SMSLG) of Grade 4 or other anatomical features (e.g., protrusion of fat under the platysma, extreme skin relaxation of the neck or submental area, protrusion of the platysma band), resulting in unacceptable cosmetic results;
• Subjects with a pre-existing tendency to scar hyperplasia or keloid may affect the efficacy assessment or subject safety after treatment as judged by the investigator;
• Subjects with symptoms of dysphagia or related diseases at screening;
• Vital signs, physical examination, clinical laboratory tests (AST or ALT values above twice the upper limit of normal; serum creatinine 1.5 times higher than the upper limit of normal) and electrocardiogram at screening showed abnormalities and judged to be clinically significant, and the investigator considered it inappropriate to participate in this study;
• Presence of other acute or chronic diseases (including but not limited to cardiovascular and cerebrovascular, respiratory, endocrine, digestive, renal, liver, blood and lymphatic, immune, metabolic and bone, central nervous system or psychiatric disorders, etc.) that may increase the risk associated with the use of the investigational product as judged by the investigator,Or may affect the interpretation of the study results, or fail to cooperate well with the trial personnel;
• Subjects who are positive for hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, treponema pallidum antibody (Anti-TP) at screening;
• Coagulation test results (prothrombin time, partial thromboplastin time) within 4 weeks prior to dosing suggest the presence of any clinically significant bleeding disorder (subjects treated with antiplatelet therapy, anticoagulant, and acetylsalicylic acid may be enrolled after a 7-day washout period);
• Those who have used topical medications (e.g., glucocorticoids, tretinoin ointment) in the submental region within 4 weeks prior to screening or are expected to require use in the submental area during the study (up to 12 weeks after the completion of the last injection);
• Plan any surgery during the trial that may result in significant weight change (≥ 10%) or take any medication that may result in significant weight change (≥ 10%) (e.g. systemic corticosteroids, bariatric medications, bariatric surgery);

Sponsors & Collaborators

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

Study Sites (1)

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, 200082, China

Location

Study Officials

• byron zhu', MD

  CMO

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: January 19, 2022
• Study Start: February 27, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)