NCT05759962已完成1 期
A Phase 1, Randomized, Double-blinded, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluated the Safety, Tolerability, Pharmacokinetics, Food Effect, and Pharmacodynamics of LQT-1213 in Healthy Adult Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Safety and Tolerability: Number of Participants with Adverse Events
研究概览
简要总结
This is a single-center, randomized, double-blind, placebo-controlled study to be conducted in 2 parts: single ascending dose (SAD) incorporating a food effect arm and multiple ascending dose (MAD). Potential participants for each part will undergo screening procedures within 28 days of enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult male or female participants
- •Females of childbearing potential must agree and commit to use an adequate form of contraception.
- •Men who are biologically capable of fathering children must agree and commit to use an adequate form of contraception.
- •Aged at least 18 years but not older than 60 years (inclusive)
- •Body mass index (BMI) within 18.0 kg/m^2 to 32.0 kg/m^2, inclusively.
- •Non- or ex-smoker
- •Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by an investigator.
排除标准
- •Clinically significant diseases or any other condition, which, in the opinion of the Investigator, would jeopardize the safety of the participant or impact the validity of the study results.
- •Clinically significant abnormal findings on the physical examination or medical history during screening as deemed by the principal investigator
- •Female who is lactating
- •Female who is pregnant
- •Male participants with a history of oligospermia or azoospermia or any other disorder of the reproductive system
- •Male participants who are undergoing treatment or evaluation for infertility.
- •History of significant hypersensitivity to LQT-1213, kinase inhibitors or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
- •Use of immunosuppressant in the 28 days prior to the first study drug administration
- •Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
- •Intake of an investigational product or participation in a clinical trial in the 90 days prior to the first study drug administration
研究组 & 干预措施
Part A: Single Ascending Dose (SAD) LQT-1213
Experimental
In Part A, 4 dosing cohorts will receive a single oral dose of LQT-1213. The highest dose of LQT-1213 to be administered is 1.67 mg/kg.
干预措施: LQT-1213 (Drug)
Part A: Food Effect LQT-1213
Experimental
In Part A, food effect will be integrated into one of the SAD cohorts as a single dose, two-period with at least a 7-day washout, crossover cohort.
干预措施: LQT-1213 (Drug)
Part B: Multiple Ascending Dose (MAD) LQT-1213
Experimental
In Part B, 3 dosing cohorts will receive LQT-1213 in the morning on Day 1 and Day 7 and twice daily (BID) on Days 2 to 6.
干预措施: LQT-1213 (Drug)
Part A: Single Ascending Dose (SAD) Placebo
Placebo Comparator
In Part A, 6 dosing cohorts will receive a single oral dose of placebo.
干预措施: Placebo (Other)
Part A: Food Effect Placebo
Placebo Comparator
In Part A, food effect will be integrated into one of the SAD cohorts as a single dose, two-period with at least a 7-day washout, crossover cohort.
干预措施: Placebo (Other)
Part B: Multiple Ascending Dose (MAD) Placebo
Placebo Comparator
In Part B, 3 dosing cohorts will receive placebo in the morning on Day 1 and Day 7 and twice daily (BID) on Days 2 to 6.
干预措施: Placebo (Other)
结局指标
主要结局
Safety and Tolerability: Number of Participants with Adverse Events
时间窗: Part A SAD: Day 7; Part A Food Effect: Day 15; Part B MAD: Day 16
Number of Participants with Adverse Events
次要结局
- Plasma Pharmacokinetics of LQT-1213: T1/2(Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8; Part B MAD: Serially on Day 1 and 7)
- Urine Pharmacokinetics of LQT-1213: Ae0-t(Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8)
- Plasma Pharmacokinetics of LQT-1213: Cmax(Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8; Part B MAD: Serially on Day 1 and 7)
- Plasma Pharmacokinetics of LQT-1213: AUC0-12, AUC0-T, and AUC0-∞=(Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8; Part B MAD: Serially on Day 1)
- Plasma Pharmacokinetics of LQT-1213: λz(Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8)
- Urine Pharmacokinetics of LQT-1213: Ae(Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8)
- Plasma Pharmacokinetics of LQT-1213: Tlag(Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8)
- Plasma Pharmacokinetics of LQT-1213: Tmax(Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8; Part B MAD: Serially on Day 1)
- Urine Pharmacokinetics of LQT-1213: CLR(Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8)
- Plasma Pharmacokinetics of LQT-1213: Ctrough(Part B MAD: Days 3-6)
- Plasma Pharmacokinetics of LQT-1213: CL/F(Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8; Part B MAD: Serially on Day 1)
- Plasma Pharmacokinetics of LQT-1213: Vz/F(Part A SAD: Serially on Day 1; Part A Food Effect: Serially on Day 1 and Day 8; Part B MAD: Serially on Day 1)
- Urine Pharmacokinetics of LQT-1213: Fe(Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8)
- Urine Pharmacokinetics of LQT-1213: Fe/F(Part A SAD and Food Effect: Serially on Day 1; Part B MAD: Serially on Days 1, 2, 7 and 8)
- Plasma Pharmacokinetics of LQT-1213: Cmin(Part B MAD: Day 7)
- Plasma Pharmacokinetics of LQT-1213: Vz/Fss(Part B MAD: Day 7)
- Plasma Pharmacokinetics of LQT-1213: AUC0-tau, AUC0-T, and AUC0-∞(Part B MAD: Day 7)
- Plasma Pharmacokinetics of LQT-1213: CL/Fss(Part B MAD: Day 7)
- Plasma Pharmacokinetics of LQT-1213: Rac(AUC) and Rac(Cmax)(Part B MAD: Day 7)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Single and Multiple Ascending Dose, First-in- Human Study in Healthy SubjectsHealthyNCT04044339Theravance Biopharma56
已完成
1 期
A First in Human Trial Evaluating THB335 in Healthy ParticipantsHealthyNCT06425861Third Harmonic Bio, Inc.60
已完成
1 期
Safety, Tolerability, and Pharmacokinetics of ACT500 in Healthy Adult ParticipantsNon-alcoholic SteatohepatitisNCT06716905Xiamen Amoytop Biotech Co., Ltd.72
撤回
1 期
Clinical Trial of Recombinant COVID-19 Vaccine (Sf9 Cells) in Children and AdolescentsCOVID-19NCT05013983WestVac Biopharma Co., Ltd.600
已完成
1 期
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of GSK2330811 in Healthy Japanese ParticipantsHealthy VolunteersNCT04138043GlaxoSmithKline9