A Phase I Study of HY-2003 in the Subjects With Excessive Submental Fat Accumulation (NCT06756490) | Clinical Trial Compass
RecruitingPhase 1
A Phase I Study of HY-2003 in the Subjects With Excessive Submental Fat Accumulation
China30 participantsStarted 2024-12-26
Plain-language summary
The main purpose of this study is to evaluate the safety of HY-2003 in subjects with moderate to severe submental fat accumulation at different doses and dosing frequencies in comparison with the positive control and placebo. The secondary objectives include: Evaluating the pharmacokinetic characteristics of HY-2003 after a single administration in humans and obtaining preliminary pharmacokinetic parameters; Evaluating the efficacy of HY-2003 under different doses and dosing frequencies, compared with the positive control and placebo, in the treatment of subjects with moderate to severe submental fat accumulation.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Fully understand the requirements of the trial, and signed the informed consent form voluntarily;
✓. The subjects should have good compliance, are able to fully understand this clinical trial, have reasonable expectations for the injection effects, and can abide by the research procedures until the end of the clinical trial.
✓. Aged 18 to 65 years (including boundary values), male or female.
✓. At screening and baseline, the investigator rated moderate to severe submental outline protrusion due to submental fat accumulation according to the clinician-reported Submental Fat Rating Scale (CR-SMFRS), i.e., those with a score of 2 to 3 points.
✓. Sufficient submental fat to allow for safe subcutaneous fat layer injections (at least 25 injections can be completed), as judged by the investigator.
✓. Stable body weight for at least 6 months prior to Screening.
✓. Vital sign examinations, physical examinations, clinical laboratory examinations (blood routine, urine routine, blood biochemistry, infectious disease screening, coagulation function, pregnancy test (for females), drug screening, etc.), and 12-lead electrocardiogram examinations, with the results showing no abnormalities or having abnormalities but judged by the researcher as being of no clinical significance.
What they're measuring
1
The occurrence of all adverse events; The occurrence of adverse events at the injection site; Laboratory tests, vital signs, physical examinations, 12-lead electrocardiograms.
Timeframe: During the intervention
2
Pain scores evaluated by the Visual Analogue Scale (VAS，0~10mm，the longer the length means a worse outcome）
Timeframe: During the intervention
3
The scores of submental skin laxity evaluated by the Submental Skin Laxity Grade (SMSLG, 0~4 points, the higher score means a worse outcome）
Timeframe: Four weeks and twelve weeks after the last treatment.
. Subjects had no pregnancy plans and voluntarily take effective contraceptive measures during the screening period and within 6 months after the last dose, and have no sperm or egg donation plans.
Exclusion criteria
✕. Subjects who have previously undergone surgical operations, liposuction treatments in the submental area that may affect the implementation and/or evaluation of the study, or have been injected with lipolytic drugs similar to the study drugs (for example, phosphatidylcholine, etc.).
✕. Subjects who have had previous allergic reactions to deoxycholic acid or other components of the investigational drug.
✕. History of hypersensitivity to topical or local anesthetics (e.g., lidocaine, benzocaine, procaine, etc.).
✕. Subjects with a history of prior surgery in the chin or neck region; or significant submental scarring, infection, cancerous or precancerous lesions, and/or unhealed wounds, mandibular retrusion (a mandibular retrusion malocclusion caused by mandibular hypoplasia or congenital absence of lower anterior teeth and lateral pterygoid insufficiency) that could affect the evaluation results as assessed by the investigator.
✕. Subjects with chin and neck skin diseases, or with a keloid-forming tendency (with a previous tendency of scar hyperplasia or keloid), which may affect the efficacy evaluation or subject safety as judged by the investigator.
✕. Subjects who have received previous lipolytic therapy with poor efficacy or serious adverse reactions.
✕. Platissimus muscle protrusion at rest, as judged by the investigator, impacts assessment of submental fat status.
✕. Including but not limited to Madelung's disease (benign symmetric lipomatosis) which leads to an increase in local fat in the neck area and needs to be excluded as judged by the investigator.