A Phase 1 Clinical Study of CU-20401 in Chinese Healthy Population

NCT05173883 | Completed Phase 1

• 1 other identifier: CU-20401-102
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, Part I/2/3/4 Phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of a single subcutaneous injection of CU-20401 in healthy Chinese population, and to recommend an appropriate dose for subsequent clinical studies.

Conditions

Healthy Subjects

Keywords

safty

Outcome Measures

Primary Outcomes (1)

• Abdominal fat volume

  The proportion of subjects with at least a 10% reduction from baseline in abdominal (dosing area) fat volume was evaluated using MRI; (Part II is limited to D29 and Part III and IV are on D29/56/84)

  Day 29/56/84

Secondary Outcomes (1)

• Abdominal fat thickness

  Day 29

Other Outcomes (1)

• the proportion of changes from baseline and changes in abdominal (dosing area) fat volume.

  Day 29/56/84

Study Arms (5)

A cohort of CU-20401

EXPERIMENTAL

Subcutaneous injection in the subcutaneous fat area，0.2ml of CU-20401, 6 injections，0.04mg/ml（A1)，0.075mg/ml(A2)，0.15mg/ml(A3)

Drug: injection ，CU-20401

B cohort of CU-20401

EXPERIMENTAL

Subcutaneous injection in the subcutaneous fat area，0.2ml of CU-20401, 12 injections，0.075mg/ml（B1)，0.10mg/ml(B2)

Drug: injection ，CU-20401

C cohort and D cohort of CU-20401

EXPERIMENTAL

Subcutaneous injection in the subcutaneous fat area，0.2ml of CU-20401, 24 injections，0.075mg/ml（C1)，0.10mg/ml(C2)，0.12mg/ml(D2),

Drug: injection ，CU-20401

A cohort of placebo

PLACEBO COMPARATOR

Subcutaneous injection in the subcutaneous fat area，0.2ml of placebo, 1 injections，0.04mg/ml（A1)，0.075mg/ml(A2)，0.15mg/ml(A3)

Drug: injection ，placebo

B cohort of placebo

PLACEBO COMPARATOR

Subcutaneous injection in the subcutaneous fat area，0.2ml of placebo, 1 injections，0.075mg/ml（B1)，0.10mg/ml(B2)

Drug: injection ，placebo

Interventions

injection ，CU-20401 DRUG

Subcutaneous injection，cohort A 6 sites

Also known as: test group administration

A cohort of CU-20401; B cohort of CU-20401; C cohort and D cohort of CU-20401

injection ，placebo DRUG

Subcutaneous injection，just one site

Also known as: Control group administration

A cohort of placebo; B cohort of placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men or women aged 18 to 50 years (including boundary values);
• Abdominal skinfold thickness ≥ 4 cm;
• Inquiries such as medical history, physical examination, vital signs, 12-lead electrocardiogram, chest X-ray, B-ultrasound and laboratory tests are normal or abnormal, and are not clinically significant as judged by the investigator;
• Female subjects had a negative blood pregnancy test; The subject has no sperm or egg donation plan within 90 days after signing the informed consent form; Subjects have no fertility plan and voluntarily take effective contraceptive measures during the study and within 90 days after dosing:
• True abstinence;
• Use of double barrier contraception, i.e. use of spermicide or cervical cap or vaginal diaphragm while using condom;
• Intrauterine device;
• Tubal ligation or hysterectomy;
• Partner sterilization for male or female subjects.
• Fully understand the purpose, requirements and risks of this study, voluntarily participate in the clinical trial and sign a written informed consent form, and can complete the entire study process in accordance with the requirements of the trial.

You may not qualify if:

• Patients with the following diseases suggested by screening examination:
• including but not limited to respiratory system, circulatory system, digestive system, blood system, endocrine system, immune system, skin system, psychoneurological system, otology and other related diseases; subjects who, as judged by the investigator, may increase relevant risks, or may affect the study results, and are not suitable for participation in this study
• Allergic constitution, history of allergy to collagenase or components of the study drug or its excipients;
• Received collagenase treatment within 6 months prior to screening;
• Received surgery, instrumental lipolysis, laser therapy within 12 months prior to screening, or planned surgery, lipolysis, laser therapy, etc., during the study;
• Having undergone liposuction surgery or taking any medication or health care product for the purpose of weight loss within six months prior to screening;
• Participated in clinical trials of other study drugs within 3 months prior to screening;
• Hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, treponema pallidum antibody (Anti-TP) test positive;
• Donation of blood within 3 months prior to screening includes component blood or massive blood loss (≥ 400 mL); those who receive blood transfusion or use blood products;
• For patients with bleeding abnormalities or currently receiving antiplatelet therapy (except for patients taking aspirin ≤ 150 mg per day) or anticoagulant therapy;
• Significant changes in abnormal diet or eating habits within 30 days prior to screening;
• Tattoos or scars, skin lesions (such as abrasions, etc.), skin infections (such as dermatitis, etc.) at the intended operation site affect the drug administration or the observer;
• History of drug abuse within 6 months prior to screening, or positive urine drug abuse screening;
• Smoking more than 5 cigarettes per day within 3 months prior to screening, or unable to stop using any tobacco products during the trial;
• Alcoholics or regular drinkers within 3 months prior to the trial, i.e., more than 21 units of alcohol per week (1 unit = 360mL of beer or 45 mL of spirits with 40% alcohol or 150 mL of wine), or those with a positive alcohol breath test;

Sponsors & Collaborators

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

Study Sites (1)

Shanghai Xuhui Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Study Officials

• TANIA LI, MM

  CUTIA

  STUDY DIRECTOR

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: November 30, 2021
• First Posted: December 30, 2021
• Study Start: December 20, 2021
• Primary Completion: November 2, 2023
• Study Completion: November 2, 2023
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)