NCT05552274已完成早期 1 期
A Randomized, Double-Blind, Placebo-Controlled, Single and Repeated Dose Escalation, FTIH Study to Investigate the Safety, Tolerability, PK and PD of ECC4703 in Healthy Volunteers and Participants With Treatment-Unnecessary LDL-C Under 160 mg/dL
Eccogene1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2022年8月16日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations
研究概览
简要总结
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study of ECC4703 in healthy volunteers and participants with treatment unnecessary LDL-C under 160 mg/dL
详细描述
This study will be conducted in two cohorts of Single Ascending Dose (SAD) with a dose range from 1mg to 400mg and in four cohorts of Multiple Ascending Dose (MAD) with a dose range of 40mg to 160mg to Investigate the Safety, Tolerability, PK, and PD of ECC4703 in Healthy Volunteers and Participants with Treatment Unnecessary LDL-C under 160 mg/dL
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double-blind
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
- •Healthy male and female participants of any ethnic origin
- •Age of 18 to 65 years
- •BMI of 18.0 to 32.0 kg/m2
- •Female participants who are postmenopausal, confirmed by FSH test, or surgically sterile, confirmed by medical documentation, or if they are of child bearing potential agree to use at least 1 highly effective method of contraception and 1 additional effective method at the same time, or agree to practice true abstinence
- •Male participants agree to use contraception, or agree to practice true abstinence
- •No clinically significant findings in physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, laboratory tests, or medical/psychiatric history
- •Not taking any medication on a regular basis
- •Able to understand and sign and date informed consent
- •Additional Inclusion Criteria for Part 2 (MAD) Cohorts B2 to B4
- •Fasting LDL-C ≥ 100 mg/dL and ≤ 159 mg/dL at screening
- •Not eligible for lipid-lowering therapy (such as statin) as decided by the qualified clinician at screening based on <2019 ACC/AHA Guidelines on the Primary Prevention of Cardiovascular Disease>
- •Hemoglobin A1c (HbA1c) ≤ 6.5%.
排除标准
- •Females who are pregnant including a positive result of pregnancy test, planning to become pregnant, or breastfeeding.
- •History of febrile illness or evidence of active infection within 14 days prior to the first dose of study;
- •Use of any concomitant medication
- •History of drug abuse or alcohol abuse within the past 5 years;
- •Regular use of tobacco, nicotine or tobacco products within the past 6 months of the study ;
- •Unwilling to abstain from alcohol containing products and/or xanthine/caffeine containing products, including any food and beverages, within 48 h prior to the first dose of study drug;
- •Concomitant participation in any investigational study of any nature
- •Blood loss of non-physiological reasons ≥ 200 ml (i.e. trauma, blood collection, blood donation) within 2 months prior to the first dose of study drug, or plan to donate blood during this trial and within 1 month after the last dosing;
- •Abnormal renal function estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73m2
- •Currently diagnosed type 2 diabetes mellitus (T2DM) or has history of T2DM.
- •Significant allergic reaction to active ingredients or excipients of the study drug.
- •Any clinically significant abnormal findings in the participant's physical examination, laboratory tests, pregnancy test, urine drug screen, alcohol test, or medical history which in the opinion of the Investigator would prevent the participants from participating in the study.
研究组 & 干预措施
SAD Cohorts 1 to 2: Participants receiving Placebo
Placebo Comparator
Participants in each SAD cohort will be randomized to receive placebo
干预措施: Placebo (Drug)
SAD Cohorts 1 to 2: Participants receiving ECC4703
Experimental
Participants in each SAD cohort will be randomized to receive up to 4 escalating doses (1 mg, 4 mg, 12 mg, 32 mg, 80 mg, 160 mg, 320 mg or 400 mg).
干预措施: ECC4703 (Drug)
MAD Cohorts 1 to 4: Participants receiving Placebo
Placebo Comparator
Participants will be randomized to receive a once-daily dose of placebo for 14 days.
干预措施: Placebo (Drug)
MAD Cohorts 1 to 4: Participants receiving ECC4703
Experimental
Participants will be randomized to receive a once-daily dose of 1 of 3 escalating doses (40 mg, 80 mg, or 160 mg) for 14 days.
干预措施: ECC4703 (Drug)
结局指标
主要结局
Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations
时间窗: SAD: Up to 8 days and MAD: Up to 21 days
Safety Assessment evaluated through adverse events, laboratory evaluations, vital signs, ECGs, and physical examination.
次要结局
- Thyroid function assessment: TSH(SAD: Up to Day 8 and MAD: Up to Day 21.)
- Pharmacokinetic Parameters: AUC0-tau(MAD: Up to Day 21.)
- Pharmacokinetic Parameters: AUC0-infinity(SAD: Up to Day 8)
- Pharmacokinetic Parameters: Cmax(SAD: Up to Day 8 and MAD: Up to Day 21.)
- Pharmacokinetic Parameters: C24(SAD: Up to Day 8 and MAD: Up to Day 21.)
- Pharmacokinetic Parameters: Ctau(MAD: Up to Day 21.)
- Pharmacokinetic Parameters: tmax(SAD: Up to Day 8 and MAD: Up to Day 21.)
- Pharmacodynamic assessment: ApoB(SAD: Up to Day 8 and MAD: Up to Day 21.)
- Thyroid function assessment: FT3(SAD: Up to Day 8 and MAD: Up to Day 21.)
- Thyroid function assessment: TT4(SAD: Up to Day 8 and MAD: Up to Day 21.)
- Thyroid function assessment: FT4(SAD: Up to Day 8 and MAD: Up to Day 21.)
- Pharmacokinetic Parameters: AUC0-tlast(SAD: Up to Day 8)
- Pharmacodynamic assessment: LDL-C(SAD: Up to Day 8)
- Pharmacodynamic assessment: TC(MAD: Up to Day 21.)
- Pharmacodynamic assessment: Glucose(MAD: Up to Day 21.)
- Pharmacokinetic Parameters: AUC0-24(SAD: Up to Day 8 and MAD: Up to Day 21.)
- Pharmacokinetic Parameters: Clast(SAD: Up to Day 8)
- Pharmacokinetic Parameters: CL/F(SAD: Up to Day 8 and MAD: Up to Day 21.)
- Pharmacodynamic assessment: LDL(MAD: Up to Day 21.)
- Pharmacokinetic Parameters: tlag(SAD: Up to Day 8 and MAD: Up to Day 21.)
- Pharmacokinetic Parameters: t1/2(SAD: Up to Day 8 and MAD: Up to Day 21.)
- Thyroid function assessment: TT3(SAD: Up to Day 8 and MAD: Up to Day 21.)
- Pharmacokinetic Parameters: tlast(SAD: Up to Day 8)
- Pharmacodynamic assessment: TG(MAD: Up to Day 21.)
- Pharmacodynamic assessment: Lp(a)(MAD: Up to Day 21.)
- Pharmacodynamic assessment: HDL-C(MAD: Up to Day 21.)
- Pharmacodynamic assessment: VLDL(MAD: Up to Day 21.)
- Pharmacodynamic assessment: Serum Insulin(MAD: Up to Day 21.)
研究者
研究点 (1)
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