NCT06241742已完成2 期
A Phase-2 Study to Evaluate the Ability of HT-6184 to Attenuate Diagnostic Biomarkers of Post-procedure Acute Inflammation and Manage Pain Following Third Molar Extraction
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Change in serum C-reactive protein levels from pre-dose
研究概览
简要总结
The goal of this clinical trial is to test the ability of HT-6184 to decrease inflammation and pain in patients after third molar removal.
The main question it aims to answer are:
- Does HT-6184 decrease inflammation in patients after third molar removal?
- Does HT-6184 decrease pain in patients after third molar removal?
Participants will be asked to do the following during the clinical trial:
- Take a single oral dose of HT-6184 or placebo
- Allow a oral surgeon remove their third molar teeth
- Blood draws on 5 occurrences
- Rate their pain intensity
- Attend two follow-up appointments on day 1 and day 2 after third molar removal
- Participate in one follow-up phone call 5-7 days after third molar removal
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The candidate is 18 years of age or older, capable of understanding and providing written informed consent to participate and willing to comply with study procedures including providing a blood sample to be saved for potential pharmacokinetic and/or genetic analysis.
- •The candidate, for any reason, requires surgical extraction of two or more third molars of which at least one is partially or fully impacted in mandibular bone.
- •The candidate is postmenopausal, surgically sterile or agrees to use an effective and medically acceptable method of contraception for 1 week after his or her last dose of study drug.
- •If female with child-bearing potential, the candidate must have a negative pregnancy test at screening and pre-surgery on the day of surgery.
排除标准
- •The candidate typically or on average consumes more than one alcoholic beverage per day.
- •The candidate is pregnant or nursing.
- •The candidate has received an investigational drug or used an experimental medical device within 30 days prior to screening.
- •The candidate has donated 1 or more pints of blood within 8 weeks prior to screening.
- •The candidate has any hypersensitivity to components of the HT-6184/placebo formulations or the protocol-specified analgesic rescue medication, aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs).
- •The candidate has any contraindication to oral surgery or any serious or major medical problems that, in the investigator's opinion, may compromise the safety or the candidate or interfere with the interpretation of study results
- •The candidate has taken acetaminophen, NSAIDs (including aspirin) or other medications for pain within 72 hours of the surgical procedure.
- •The candidate has any abnormal laboratory value or physical finding that, in the opinion of the investigator, may compromise the individual's safety, interfere with interpretation of the study results, or be indicative of an underlying disease state.
研究组 & 干预措施
HT-6184 Treatment Arm
Active Comparator
干预措施: HT-6184 (Drug)
HT-6184 Placebo
Placebo Comparator
干预措施: HT-6184 Placebo (Drug)
结局指标
主要结局
Change in serum C-reactive protein levels from pre-dose
时间窗: Up to 54 hours post surgery
Incidence of adverse events
时间窗: Up to 7 days post surgery
Severity of AEs will be judged according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Incidence of serious adverse events
时间窗: Up to 7 days post surgery
Severity of AEs will be judged according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
次要结局
- Area under the categorical pain intensity-by-time curve (AUCs)(Up to 8 hours after surgery)
研究者
研究点 (1)
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相关资讯
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- Halia Therapeutics is also advancing HT-6184, a NEK7/NLRP3 inhibitor, with ongoing Phase II trials for myelodysplastic syndromes.last yearHalia Therapeutics Presents Phase II Data on HT-6184 for Post-Procedural Inflammation and Pain- Halia Therapeutics presented Phase II clinical trial data for HT-6184, an oral NEK7/NLRP3 inhibitor, at the 6th Inflammasome Therapeutics Summit.
- The study (NCT06241742) evaluated HT-6184's efficacy in reducing post-procedural inflammation and pain following third molar extraction.
- HT-6184 targets the NLRP3 inflammasome, aiming to improve outcomes in inflammatory and neurodegenerative diseases by inhibiting IL-1β and IL-18 release.
- The presentation highlighted innovative endpoints for measuring therapeutic benefit in inflammatory-induced pain, offering time-effective assessments.2 years ago