A Phase I Study of HY-2003 in the Subjects With Excessive Submental Fat Accumulation
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSichuan Huiyu Pharmaceutical Co., Ltd
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- HY-2003 (10 mg/ml), BELKYRA and placebo
- HY-2003 (5 mg/ml) and placebo
- HY-2003 (5 mg/ml) and placebo
Treatment groups
30 Participants
are divided into 3 treatment groupsSponsors and collaborators
Sichuan Huiyu Pharmaceutical Co., Ltd
Lead sponsor
Peking Union Medical College Hospital
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
Source ClinicalTrials.gov