NCT06537817已完成1 期
A Phase 1, First-in-Human, Randomized, Placebo-Controlled, Double-Blind Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses (SAD) and Multiple Ascending Doses (MAD) of Oral HT-4253 in Healthy Adults
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To evaluate the safety and tolerability of single and multiple ascending doses of oral HT-4253 in healthy adults
研究概览
简要总结
The primary objectives of this study are to evaluate the safety and tolerability of HT-4253 when administered as single oral doses and multiple oral doses at escalating dose levels in healthy volunteer subjects.
The secondary objectives of this study are to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of HT-4253.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- 是
入选标准
- •Age is ≥ 18 years to 65 years
- •Body mass index between 18 and 32 kg/m2
- •Female subjects must be surgically sterile or post menopausal for at least 12 months. Females may be of child-bearing potential but must use double contraception.
排除标准
- •Any clinically significant central nervous system, cardiac, pulmonary, renal, gastrointestinal, endocrinological, respiratory, or metabolic conditions (or history), or other pathological or physiological conditions,
- •History of suicidal behavior and/or ongoing suicidal ideation per C-SSRS evaluation when screening
- •Use of any medications, including prescription, over-the-counter (OTC) medications, vitamins, herbal preparations, and supplements
- •Positive drug screen or alcohol breath tests
- •History of heavy smoking more than 10 cigarettes a day or the tobacco/nicotine equivalent within 3 months of Screening or refuses to abstain from tobacco or nicotine-containing products throughout the duration of the study
- •Clinical significant abnormalities in laboratory test results
- •Chronic or current active infectious disease
研究组 & 干预措施
HT-4253
Experimental
Subjects will participate in 1 of 10 groups and receive single or multiple doses of HT-4253 or matching placebo. In each group 6 subjects will receive HT-4253.
干预措施: HT-4253 (Drug)
Placebo to match HT-4253
Placebo Comparator
Subjects will participate in 1 of 10 groups and receive single or multiple doses of HT-4253 or matching placebo. In each group 2 subjects will receive matching placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of single and multiple ascending doses of oral HT-4253 in healthy adults
时间窗: up to 6 weeks
Treatment-related adverse events (TRAEs)
To evaluate the safety and tolerability of single and multiple ascending
时间窗: up to 6 weeks
Incidence of withdrawals due to AE
次要结局
- To evaluate the plasma pharmacokinetics (PK) of single and multiple ascending doses of oral HT-4253 in healthy adults(up to 6 weeks)
研究者
研究点 (1)
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相关资讯
Halia Therapeutics Completes Enrollment in Phase 2a Trial of Novel NLRP3 Inflammasome Inhibitor for Myelodysplastic Syndrome- Halia Therapeutics has completed enrollment of 33 patients in its Phase 2a clinical trial evaluating HT-6184 (Ofirnoflast) for lower-risk myelodysplastic syndrome patients who are refractory to or ineligible for erythropoiesis-stimulating agents.
- HT-6184 represents a novel therapeutic approach as an allosteric modulator of NEK7 that disrupts the NEK7-NLRP3 protein interaction, preventing NLRP3 inflammasome formation and targeting inflammatory pathways implicated in bone marrow dysfunction.
- The two-stage study design includes a 16-week treatment period with response-based continuation, evaluating efficacy through hematological improvement, clonal suppression, and variant allele frequency reduction.
- Topline results from the complete study are expected later this year, with the potential to validate a new mechanism of action targeting innate immune dysregulation in MDS treatment.last yearHalia Therapeutics Presents LRRK2 Inhibitor HT-4253 for Neurodegenerative Diseases at BIO Investor Forum- Halia Therapeutics' CEO, Dr. David J. Bearss, will participate in a panel at the BIO Investor Forum on October 15, 2024, focusing on neurodegenerative disease targets.
- The panel will discuss advancements in neurodegenerative disease research, novel targets, and implications for future treatments and investment opportunities.
- Halia Therapeutics has initiated a Phase 1 trial for HT-4253, an orally administered LRRK2 inhibitor, assessing its safety and tolerability in healthy adults.
- HT-4253 targets LRRK2, a key regulator of neuroinflammation associated with Alzheimer's and Parkinson's disease, offering a potential new approach to treating these diseases.last yearHalia Therapeutics Doses First Healthy Volunteer with Oral LRRK2 Inhibitor HT-4253 for Alzheimer's- Halia Therapeutics initiated a Phase 1 clinical trial for HT-4253, a novel oral LRRK2 inhibitor, with the first healthy volunteer dosed.
- The trial (NCT06537817) is a randomized, placebo-controlled, double-blind study assessing safety, tolerability, pharmacokinetics, and pharmacodynamics of HT-4253.
- HT-4253 targets LRRK2 to reduce neuroinflammation, potentially preventing or delaying Alzheimer's onset, especially in individuals with the APOE4 genotype.
- Halia Therapeutics is also advancing HT-6184, a NEK7/NLRP3 inhibitor, with ongoing Phase II trials for myelodysplastic syndromes.last year