SafetyPhase 1/2NCT05195541
A Clinical Study to Evaluate the Safety, Pharmacokinetic Profile and Efficacy of CU-20401
A Phase 1/2 study testing CU-20401 in people with Safety, run by Cutia Therapeutics（Wuxi）Co.,Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety
- What is being tested?
- 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
- 27 Feb 2022to 30 Dec 2022
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- -
Who cannot join
- 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;
Show all 26Show fewer
- 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);
- Donation of blood or massive blood loss (≥ 400 mL) within 3 months prior to screening;
- Those with a history of needle sickness and blood sickness and significant abnormal clinical manifestations;
- History of drug abuse within 6 months prior to screening, or drug use within 3 months prior to screening (including but not limited to morphine, methamphetamine,ketamine, tetrahydrocannabinol acid, methylenedioxymethylamphetamine, etc.);
- Alcoholics or regular drinkers within 3 months prior to the trial, i.e., more than 21 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits with 40% alcohol or 150 mL of wine), or those with a positive alcohol breath test.
- 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;
- Participation in any drug within 3 months prior to screening or medical device clinical trials within 1 month prior to screening;
- Lactating and pregnant women;
- Those who cannot tolerate magnetic resonance imaging (MRI) (e.g., with a pacemaker/electronic stimulator, an insulin pump, a cochlear implant, or stainless steel metal implanted in the body, etc.);
- 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 Clinical Study to Evaluate the Safety, Pharmacokinetic Profile and Efficacy of CU-20401 Administered Subcutaneously in the Submental Fat (SMF) Population
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.
Read the detailed description
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.
- Conditions
- Safety
- Being tested
- CU-20401
- Keywords
- pharmacokinetic profile, efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CU-20401Drug
Also called injection，CU-20401
Subcutaneous injection in the subcutaneous fat area，0.2ml
| Study group | Role | What they receive |
|---|---|---|
| Cohort A1 | Experimental | 0.02mg/injection，2 injections Receives: Drug: CU-20401 |
| Cohort A2 | Experimental | 0.04mg/injection，2 injections Receives: Drug: CU-20401 |
| Cohort B1 | Experimental | 0.04mg/injection，4 injections Receives: Drug: CU-20401 |
| Cohort B2 | Experimental | 0.075mg/injection，4 injections Receives: Drug: CU-20401 |
| Cohort C1 | Experimental | 0.075mg/injection，6 injections Receives: Drug: CU-20401 |
| Cohort C2 | Experimental | 0.15mg/injection，6 injections Receives: Drug: CU-20401 |
| cohort X1 | Experimental | 0.04mg/injection，20 injections Receives: Drug: CU-20401 |
| cohort X2 | Experimental | 0.075mg/injection，20 injections Receives: Drug: CU-20401 |
| cohort X3 | Experimental | 0.15mg/injection，20 injections Receives: Drug: CU-20401 |
| cohort X | Placebo comparator | 0.15mg of placebo /injection，20 injections Receives: Drug: CU-20401 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 month
Occurrence of other adverse events
such as abnormalities in laboratory tests, electrocardiograms, etc
Measured: 1 month
Secondary outcomes (6)
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
Measured: 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。
Measured: 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
Measured: 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.
Measured: 1 month
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
Measured: 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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start27 Feb 2022
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies 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 1/2
- 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
- byron zhu', MD, Study chair, CMO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195541
- Sponsor's protocol ID
- CU-20401-104
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 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 Clinical Study to Evaluate the Safety, Pharmacokinetic Profile and Efficacy of CU-20401 Administered Subcutaneously in the Submental Fat (SMF) Population
- ClinicalTrials.gov ID
- NCT05195541
- Acronym / sponsor ID
- CU-20401-104
- Conditions
- Safety
- Keywords
- pharmacokinetic profile, efficacy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Cutia Therapeutics（Wuxi）Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 19 Jan 2022 (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 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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Cohort A1 | Experimental | Drug: CU-204010.02mg/injection，2 injections |
| Cohort A2 | Experimental | Drug: CU-204010.04mg/injection，2 injections |
| Cohort B1 | Experimental | Drug: CU-204010.04mg/injection，4 injections |
| Cohort B2 | Experimental | Drug: CU-204010.075mg/injection，4 injections |
| Cohort C1 | Experimental | Drug: CU-204010.075mg/injection，6 injections |
| Cohort C2 | Experimental | Drug: CU-204010.15mg/injection，6 injections |
| cohort X1 | Experimental | Drug: CU-204010.04mg/injection，20 injections |
| cohort X2 | Experimental | Drug: CU-204010.075mg/injection，20 injections |
| cohort X3 | Experimental | Drug: CU-204010.15mg/injection，20 injections |
| cohort X | Placebo comparator | Drug: CU-204010.15mg of placebo /injection，20 injections |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (26 listed)
- 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;
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 |
|---|---|---|
| CU-20401Also: injection，CU-20401Subcutaneous injection in the subcutaneous fat area，0.2ml | Drug | Cohort A1, Cohort A2, Cohort B1, Cohort B2, Cohort C1, Cohort C2, cohort X, cohort X1, cohort X2, cohort X3 |
Primary outcome
Occurrence of local skin reactions
Time frame: 1 month
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).
Occurrence of other adverse events
Time frame: 1 month
such as abnormalities in laboratory tests, electrocardiograms, etc
6 secondary outcomes
Proportion of subjects with Submental Fat（SMF）Grade ≤ 1
Time frame: 1 month
Changes in SMF skin laxity compared to baseline
Time frame: 1 month
The proportion of subjects with SMF score ≥ 3 points
Time frame: 1 month
Proportion of subjects with at least a 10% reduction from baseline in submental fat area
Time frame: 1 month
Changes in overall aesthetics compared to baseline
Time frame: 1 month
Changes in SMF compared to baseline
Time frame: 1 month
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
Related trials for Safety
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Recruiting
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
Anastomotic Leaks, Hartmanns Stump Leakage
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
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.
byron zhu', MD study chair
CMO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CU-20401 in people with Safety, 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 6 inclusion and 26 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Occurrence of local skin reactions (time frame: 1 month). The study lists 2 primary outcomes in all. 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.