A Phase 2 Study of STP705 Injection for Submental Fat Reduction
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Sirnaomics
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The efficacy of STP705 injection for SMF reduction
研究概览
简要总结
This Phase 2 study aims to assess the efficacy of SC injections of STP705 for the reduction of Submental fat in apopulation of healthy adult volunteers, and to further establish its safety and tolerability.
The primary objective is to evaluate the efficacy of STP705 injection for Submental fat reduction. The second objective is to evaluate the safety and tolerability of STP705 injection.
This is an open-label study. Eligible participants will be sequentially enrolled into 1 of 3 treatment cohorts, as follows:
Cohort 1: 40 µg STP705 per injection. Up to 280 µg in total (n = 10 participants) Cohort 2: 64 µg STP705 per injection. Up to 448 µg in total (n = 10 participants) Cohort 3: 80 µg STP705 per injection. Up to 560 µg in total (n = 10 participants)
The STP705 powder will be reconstituted with dextrose 5% in water (D5W). A total of 7 injections (3.5 mL total volume) in a single treatment may be administered to each participant in the submental triangle area (ie, for a total dose of up to 280 µg, 448 µg or 560 µg STP705 for each cohort). The Submental fat injections will be performed at Day 1/Baseline, Day 29, and Day 57 , pending favourable reviews by the Investigator of injection site reactions (ISRs), local skin reactions (LSRs), and participant assessments of the injection sites (pain, stinging, and burning). To proceed with treatment at Day 29 or Day 57, the following factors will be considered:
- the total tolerability score per injection site (defined as the sum of the "Investigator assessed LSRscores" and the "participant-reported scores of injection site pain and stinging/burning" measured prior totreatment must be < 6, and
- there are no findings (eg, systemic and/or local adverse events [AEs]) that would preclude treatment, in the opinion of the Investigator. The tolerability score threshold should be interpreted in conjunction with clinical judgment. If condition a) is not met, participants with a total tolerability score = 6 will not be injected with the study medications. After the 3rd injection, the participant will be followed for 1 month (through to Day 85). To proceed with dose escalation (ie, from Cohort 1 to Cohort 2 or from Cohort 2 to Cohort 3), the last participant in the previous dose cohort must have completed at least 7 days of postdose safety follow-up after the first injection, and available safety data will be reviewed by the Sponsor and Medical Monitor. The decision to escalate dose will be made upon review of all data by the Medical Monitor and the Sponsor and recommendation by the Sponsor.
详细描述
Participant Study Duration: Total duration of study participation for each participant: Approximately 16 weeks (4 weeks Screening, 8 weeks Treatment, and 4 weeks Follow-up).
Number of Participants (Planned): Approximately 30 participants will be enrolled into the study.
Diagnosis and Main Criteria for Inclusion:
To be eligible for this study, a participant must meet all of the following inclusion criteria:
- Aged 18 to 65 years of age, inclusive, at the time of Screening.
- Body mass index of ≤ 40.0 kg/m2.
- Good general health, in the opinion of the Investigator or designee, with no clinically significant medical history, and have no clinically significant abnormalities on physical examination, electrocardiogram (ECGs), or laboratory assessments at Screening and/or before the first administration of the IP.
- Grade 2 or 3 Submental fat, as assessed by the Investigator using the Clinician-Reported-Submental Fat Rating Scale (CR-SMFRS) AND as assessed by the participant using the Participant-Reported- Submental Fat Rating Scale (PR-SMFRS).
- Dissatisfaction with the submental area, as assessed by the participant as a rating of 0, 1, or 2 using the Participant-Self Satisfaction Scale (PSSS).
- History of stable body weight for at least 6 months (+/- 5 kg) prior to first dosing with the IP.
- Woman of childbearing potential (WOCBP) or fertile man (see definitions in Section 5.3 agrees to use an acceptable method of contraception from the start of Screening until 90 days after thelast dose of IP.
- Agrees to refrain from making significant changes, in the judgement of the Investigator, to dietary or exercise habits during the study.
- Agrees to forego any treatment or behaviour (eg, unshaven facial hair) during the participation in the study that may affect the assessments of the submental area.
- No clinically significant abnormalities at Screening on clinical and laboratory tests, at the discretion of the Investigator.
- Able and willing to attend the necessary visits to the study site.
- Able and willing to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 65 years of age, inclusive, at the time of Screening.
- •Body mass index of ≤ 40.0 kg/m
- •Good general health, in the opinion of the Investigator or designee, with no clinically significant medical history, and have no clinically significant abnormalities on physical examination, electrocardiogram (ECGs), or laboratory assessments at Screening and/or before the first administration of the IP.
- •Grade 2 or 3 Submental fat, as assessed by the Investigator using the Clinician-Reported-Submental Fat Rating Scale (CR-SMFRS) AND as assessed by the participant using the Participant-Reported- Submental Fat Rating Scale (PR-SMFRS).
- •Dissatisfaction with the submental area, as assessed by the participant as a rating of 0, 1, or 2 using the Participant-Self Satisfaction Scale (PSSS).
- •History of stable body weight for at least 6 months (+/- 5 kg) prior to first dosing with the IP.
- •Woman of childbearing potential (WOCBP) or fertile man agrees to use an acceptable method of contraception from the start of Screening until 90 days after the last dose of IP. Acceptable methods of contraception are defined in .
- •Agrees to refrain from making significant changes, in the judgement of the Investigator, to dietary or exercise habits during the study.
- •Agrees to forego any treatment or behaviour (eg, unshaven facial hair) during the participation inthe study that may affect the assessments of the submental area.
- •No clinically significant abnormalities at Screening on clinical and laboratory tests, at the discretion of the Investigator.
- •Able and willing to attend the necessary visits to the study site.
- •Able and willing to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.
排除标准
- •History of any intervention to treat Submental fat (eg, liposuction, surgery, or lipolytic agents).
- •Treatment with botulinum toxin injections in the neck or chin area within 6 months prior to the first dosing with the IP through the end of study (EOS).
- •History of trauma associated with the chin or neck areas that in the judgement of the Investigator may affect evaluation of safety or efficacy of treatment.
- •Evidence of any cause of enlargement in the submental area (eg, thyroid enlargement, cervical adenopathy) other than localised Submental fat.
- •A Submental Skin Laxity Grade (SMSLG) of 4 or other anatomical feature (eg, predominant subplatysmal fat, loose skin in the neck or chin area, prominent platysmal bands), as assessed within 28 days prior to the first dosing with the IP, for which reduction in Submental fat may, in the judgement of the Investigator, result in an aesthetically unacceptable outcome.
- •Treatment with radio frequency, laser procedures, ultrasound, chemical peels, or dermal fillers in the neck or chin area within 12 months prior to first dosing with the IP and through the end of study(EOS).
- •History or current symptoms of dysphagia.
- •Any medical condition (eg, respiratory, cardiovascular, hepatic, neurological disease, or thyroid dysfunction) that (in the opinion of the Investigator) would interfere with assessment of safety or efficacy or compromise the participant's ability to undergo study procedures or give informed consent.
- •History of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents.
- •Treatment with an investigational device or agent within 30 days prior to the first dosing with the IP and through the end of study(EOS).
- •Blood or plasma donation or had significant blood loss (> 500 mL) within 30 days prior to the first dosing with the IP.
- •History of severe Type I-IV hypersensitivity reactions.
- •History of cytokine release syndrome (CRS).
- •History of marginal mandibular nerve injury.
- •History or current lower facial weakness and/or lower facial asymmetry.
- •Pregnancy, breastfeeding, or planning to breastfeed during the study and for at least 90 days (approximately 5 half-lives of the study drug) after the last dose of study treatment.
- •Unwillingness to use medically acceptable methods of contraception during the study and for at least 90 days after the last dose of study treatment.
- •Presence of genetic or endocrine disorders associated with obesity that are not amenable to submental fat reduction, including but not limited to Cohen syndrome, Alström syndrome, Prader-Willi syndrome, untreated hypothyroidism, Cushing's syndrome, or lipodystrophy syndromes.
- •Active dermatitis, open wounds, or infection in the treatment area.
- •Medical conditions affecting platelet function or coagulation.
- •Use of medications that affect coagulation or platelet function within 14 days prior to the first dosing of the IP, or unwillingness to abstain from such medications through the end of study(EOS).
- •Use of tanning beds and/or excessive sun exposure within 14 days prior to the first dosing of the IP, or unwillingness to abstain from these during the study through the end of study(EOS).
研究组 & 干预措施
Cohort 3
Cohort 3: 80 µg STP705 per injection. Up to 560 µg in total (n = 10 participants)
干预措施: STP705 (Drug)
Cohort 1
Cohort 1: 40 µg STP705 per injection. Up to 280 µg in total (n = 10 participants)
干预措施: STP705 (Drug)
Cohort 2
Cohort 2: 64 µg STP705 per injection. Up to 448 µg in total (n = 10 participants)
干预措施: STP705 (Drug)
结局指标
主要结局
The efficacy of STP705 injection for SMF reduction
时间窗: From baseline to day85
Percentage of participants with a ≥ 1-grade improvement in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score from Baseline to the End-of-Study Visit (Day 85). Percentage of participants with a ≥ 1-grade improvement in Participant-Reported Submental Fat Rating Scale (PR-SMFRS) score from Baseline to the End-of-Study Visit (Day 85).
次要结局
- The efficacy of STP705 injection for SMF reduction(Screening Visit, Day 1, Day 29, Day 57, Day 85)
- The participant satisfaction on STP705 injection for SMF reduction(Screening Visit, Day 1, Day 29, Day 57, Day 85)
- The safety and tolerability of STP705 injections for SMF reduction(Screening Visit, Day 1, Day 29, Day 57, Day 85)