Health TrialsbyHealthPanel

A Phase I Study of HY-2003 in the Subjects With Excessive Submental Fat Accumulation

ConditionModerate or Severe Submental Fullness
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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • HY-2003 (10 mg/ml), BELKYRA and placebo

    Drug

    Participants received HY-2003 (10 mg/ml), or BELKYRA, or placebo administered up to 10 mL per treatment session at intervals of approximately 4 weeks for up to a maximum of 6 treatments.

  • HY-2003 (5 mg/ml) and placebo

    Drug

    Participants received HY-2003 (5 mg/ml) or placebo administered up to 10 mL per treatment session at intervals of approximately 2 weeks for up to a maximum of 6 treatments.

  • HY-2003 (5 mg/ml) and placebo

    Drug

    Participants received HY-2003 (10 mg/ml) or placebo administered up to 10 mL per treatment session at intervals of approximately 4 weeks for up to a maximum of 6 treatments. It is possible to explore the maximum number of administrations exceeding six treatment sessions.

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Group A - Subjects will be randomly assigned to three subgroupsExperimental treatment 1 intervention
Group B: Group B - Subjects will be randomly assigned to two subgroupsExperimental treatment 1 intervention
Group C: Group C - Subjects will be randomly assigned to two subgroupsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
During the intervention
2

Pain scores evaluated by the Visual Analogue Scale (VAS，0~10mm，the longer the length means a worse outcome）

Time frame
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）

Time frame
Four weeks and twelve weeks after the last treatment.

Secondary outcomes

Other outcomes

Sponsors and contacts

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Sichuan Huiyu Pharmaceutical Co., Ltd

Lead sponsor

Peking Union Medical College Hospital

Collaborator

First Affiliated Hospital Xi'an Jiaotong University

Collaborator

Source ClinicalTrials.gov
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