Healthy SubjectsPhase 1NCT05173883
A Phase 1 Clinical Study of CU-20401 in Chinese Healthy Population
A Phase 1 study testing injection ，CU-20401 in people with Healthy Subjects, run by Cutia Therapeutics（Wuxi）Co.,Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- injection ，CU-20401
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2021to 2 Nov 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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.
- -
Who cannot join
- 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;
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- 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;
- Subjects unable to undergo MRI;
- Other conditions judged by the investigator to be inappropriate for participation in this study.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a Single Subcutaneous Injection of CU-20401 in Chinese Healthy Population
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.
Read the detailed 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.
Eligible subjects were sequentially enrolled in Dose Group B1 (0.075 mg/dose) and Dose Group B2 (0.10 mg/dose) to receive the established dose. All examinations (vital signs, physical examination, laboratory tests, 12-lead ECG, abdominal B-ultrasound, 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 no intolerable safety events have occurred. The subject continued to receive subsequent follow-up (D14/D21/D29).
Eligible subjects were sequentially enrolled in dose group C1 (0.075 mg/dose) and dose group C2 (0.10 mg/dose) to receive the established dose; doses were administered bilaterally with 12 injections on each side. All examinations (vital signs, physical examination, laboratory tests, 12-lead ECG, abdominal B-ultrasound, etc.) were performed during the dosing observation period. During the follow-up period, a visit on D7/D14/D21/D29/D56/D84 was required. After subjects in Part III have completed at least the visit on D29, and no intolerable safety events have occurred, Part IV of the study may be conducted in consultation with the investigator and the sponsor.
Based on the available data, a dose of 0.12 mg/dose is tentatively proposed for Part 4 of the study, administered bilaterally with 12 injections on each side. The study procedures are the same as Part III.
- Conditions
- Healthy Subjects
- Being tested
- injection ，CU-20401, injection ，placebo
- Keywords
- safty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection ，CU-20401Drug
Also called test group administration
Subcutaneous injection，cohort A 6 sites
injection ，placeboDrug
Also called Control group administration
Subcutaneous injection，just one site
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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), Receives: 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) Receives: 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) Receives: Drug: injection ，placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 29/56/84
Secondary outcomes (1)
Abdominal fat thickness
The thickness of abdominal fat on day 29 changes from baselinefat thickness in the abdominal B-ultrasound administration area in all subjects receiving the investigational product, and the relationship between the administered dose and efficacy will be assessed.
Measured: Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start20 Dec 2021
- Primary completion2 Nov 2023
- Study completion2 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cutia Therapeutics（Wuxi）Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- TANIA LI, MM, Study director, CUTIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173883
- Sponsor's protocol ID
- CU-20401-102
- Status last verified
- Dec 2024
- First submitted
- 30 Nov 2021
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a Single Subcutaneous Injection of CU-20401 in Chinese Healthy Population
- ClinicalTrials.gov ID
- NCT05173883
- Acronym / sponsor ID
- CU-20401-102
- Conditions
- Healthy Subjects
- Keywords
- safty
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Cutia Therapeutics（Wuxi）Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 2 Nov 2023 (actual)
- Study completion
- 2 Nov 2023 (actual)
- First posted
- 30 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Eligible subjects were sequentially enrolled in Dose Group B1 (0.075 mg/dose) and Dose Group B2 (0.10 mg/dose) to receive the established dose. All examinations (vital signs, physical examination, laboratory tests, 12-lead ECG, abdominal B-ultrasound, 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 no intolerable safety events have occurred. The subject continued to receive subsequent follow-up (D14/D21/D29).
Eligible subjects were sequentially enrolled in dose group C1 (0.075 mg/dose) and dose group C2 (0.10 mg/dose) to receive the established dose; doses were administered bilaterally with 12 injections on each side. All examinations (vital signs, physical examination, laboratory tests, 12-lead ECG, abdominal B-ultrasound, etc.) were performed during the dosing observation period. During the follow-up period, a visit on D7/D14/D21/D29/D56/D84 was required. After subjects in Part III have completed at least the visit on D29, and no intolerable safety events have occurred, Part IV of the study may be conducted in consultation with the investigator and the sponsor.
Based on the available data, a dose of 0.12 mg/dose is tentatively proposed for Part 4 of the study, administered bilaterally with 12 injections on each side. The study procedures are the same as Part III.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| A cohort of CU-20401 | Experimental | Drug: injection ，CU-20401Subcutaneous 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) |
| B cohort of CU-20401 | Experimental | Drug: injection ，CU-20401Subcutaneous injection in the subcutaneous fat area，0.2ml of CU-20401, 12 injections，0.075mg/ml（B1)，0.10mg/ml(B2) |
| C cohort and D cohort of CU-20401 | Experimental | Drug: injection ，CU-20401Subcutaneous 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), |
| A cohort of placebo | Placebo comparator | Drug: injection ，placeboSubcutaneous injection in the subcutaneous fat area，0.2ml of placebo, 1 injections，0.04mg/ml（A1)，0.075mg/ml(A2)，0.15mg/ml(A3) |
| B cohort of placebo | Placebo comparator | Drug: injection ，placeboSubcutaneous injection in the subcutaneous fat area，0.2ml of placebo, 1 injections，0.075mg/ml（B1)，0.10mg/ml(B2) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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:
- 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.
Key exclusion criteria (22 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| injection ，CU-20401Also: test group administrationSubcutaneous injection，cohort A 6 sites | Drug | A cohort of CU-20401, B cohort of CU-20401, C cohort and D cohort of CU-20401 |
| injection ，placeboAlso: Control group administrationSubcutaneous injection，just one site | Drug | A cohort of placebo, B cohort of placebo |
Primary outcome
Abdominal fat volume
Time frame: Day 29/56/84
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)
1 secondary outcome
Abdominal fat thickness
Time frame: Day 29
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TANIA LI, MM study director
CUTIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing injection ，CU-20401 in people with Healthy Subjects, run by Cutia Therapeutics（Wuxi）Co.,Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal fat volume (time frame: Day 29/56/84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.