Clinical Study of CU-20401

  • STATUS
    Recruiting
  • days left to enroll
    60
  • participants needed
    42
  • sponsor
    Cutia Therapeutics(Wuxi)Co.,Ltd
Updated on 10 August 2022
Accepts healthy volunteers

Summary

This is an open-label, Part I/2/3 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.

Description

In Part 1, 3 dose groups (dose group A1) were prespecified : 0.04 mg/dose; Dose Group A2 : 0.075 mg/dose; Dose Group A3 : 0.15 mg/dose). Eligible subjects were enrolled in the order from the low dose group to the high dose group (A1 → A2 → A3), and all subjects in the first dose group completed dosing.All examinations (vital signs, physical examination, laboratory tests, 12-lead ECG, abdominal wall color ultrasonography, etc.) will be performed during the dosing observation period and the follow-up period. Only after the investigator confirms that no subject meets the criteria for discontinuation of escalation, the next dose group can be started. Two subjects will be enrolled in each dose group for at least 24 h, and the remaining 4 subjects will not be enrolled until no safety events have occurred.

B2 (if any) to receive the established dose. All examinations (vital signs, physical examination, laboratory tests, 12-lead ECG, abdominal wall color ultrasonography, etc.) will be performed during the dosing observation period .All subjects may enter Part 3 of the study after the investigator confirms that all subjects have completed the visit on D7 and have no intolerable safety events.

Eligible subjects were sequentially enrolled in dose group C1 and dose group C2 (if any) to receive the established dose. All examinations (vital signs, physical examination, laboratory tests, 12-lead electrocardiogram, abdominal wall color ultrasonography, etc.) were performed during the dosing observation period .All subjects could end the study after the investigator confirmed that all subjects completed the visit on D29 of the follow-up period and no intolerable safety events occurred.

Details
Condition Healthy Subjects
Treatment injection ,CU-20401, injection ,placebo
Clinical Study IdentifierNCT05173883
SponsorCutia Therapeutics(Wuxi)Co.,Ltd
Last Modified on10 August 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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, abdominal color ultrasonography 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
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Exclusion Criteria

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
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
Current or former drug user
Vaccinated within 1 month prior to screening
Suffering from other acute or chronic medical or psychiatric disorders that, as judged by the investigator, are not suitable for participation in this study, may increase the risks associated with participation in this study, or may interfere with the interpretation of the study results
Lactating and pregnant women
Other conditions judged by the investigator to be inappropriate for participation in this study
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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