NCT07760467招募中1 期
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Characteristics of Single and Multiple Doses of TUL321 Capsule in Healthy Participants, and the Effect of Food on Pharmacokinetics
Zhuhai United Laboratories Co., Ltd.2 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2026年8月26日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- 1.Incidence of adverse events (AEs) 2.Changes from baseline in physical examinations, vital signs, electrocardiograms (ECG), and laboratory tests
研究概览
简要总结
Phase I Study Evaluating Safety, Tolerability, PK and PD of Single and Multiple Doses of TUL321 Capsule in Healthy Participants and Food Effect on PK
详细描述
Primary Objective:
To evaluate the safety and tolerability following single and multiple oral dministrations of TUL321 capsules in healthy participants.
Secondary Objectives:
- To characterize the pharmacokinetic (PK) profiles following single and multiple oral administrations of TUL321 capsules in healthy participants;
- To evaluate the effect of a high-fat meal on the PK profiles after a single oral administration of TUL321 capsules in healthy participants;
- To preliminarily assess the in vivo biotransformation and mass balance characteristics following single oral administration of TUL321 capsules;
- To characterize the pharmacodynamic (PD) profiles following single and multiple oral administrations of TUL321 capsules in healthy participants;
- To evaluate the effect of single oral administration of TUL321 capsules on the QT/QTc interval.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants can communicate well with investigators, fully understand the study, volunteer to take part, comply with all study requirements, and sign written informed consent before study procedures.
- •Age 18-45 years (inclusive) at informed consent, male or female.
- •Weight ≥50.0 kg for males, ≥45.0 kg for females; BMI 19.0-26.0 kg/m² (inclusive).
- •Female participants with child-bearing potential, and male participants whose partners have child-bearing potential: no pregnancy, sperm or egg donation from consent to 3 months after last dose, and willing to use study-required contraception.
- •For MAD-only participants: receive ACYW135 meningococcal vaccine and pneumococcal vaccine at least 14 days before first dose. No re-vaccination is needed if pneumococcal vaccine was given within 5 years, or ACYW135 meningococcal vaccine within 3 years prior to first dose.
排除标准
- •Suspected or confirmed allergy to investigational product or its similar components; or history of multiple drug/food allergies.
- •Past history of tuberculosis infection or active tuberculosis at screening.
- •Known or suspected history of immunodeficiency, inherited or acquired complement deficiency.
- •Confirmed active systemic bacterial, viral or fungal infection within 2 weeks before screening.
- •History of confirmed encapsulated bacterial infection within 6 months before screening, including but not limited to meningococcus, streptococcus pneumoniae, Haemophilus influenzae type b.
- •Clinically significant abnormal findings in laboratory tests, physical examination, vital signs, ECG, chest X-ray or abdominal ultrasound at screening.
- •QTcF (Fridericia correction) ≥450 ms at screening; or other risk factors for torsades de pointes (TdP), such as heart failure, hypokalemia, hypomagnesemia, family history of long QT syndrome.
- •eGFR <90 mL/min/1.73 m² (calculated by CKD-EPI formula) at screening.
- •Positive for HBsAg, anti-HCV, anti-HIV or syphilis-specific antibody at screening.
- •Received other vaccines not specified in the protocol within 1 month before screening, or plan to receive such vaccines during the study.
- •Participated in another interventional clinical trial within 3 months before screening (excluding subjects who only completed screening without enrollment, or enrolled but did not receive study treatment).
- •Average daily cigarette consumption >5 cigarettes within 3 months before screening.
- •History of drug/substance abuse within 6 months before screening, or positive drug abuse screening test.
- •Chronic constipation or diarrhea, or other conditions judged by investigator to interfere with fecal sample collection.
- •Required or plan to perform heavy physical labor or strenuous exercise during study participation.
- •Pregnant or lactating women, or women of child-bearing potential with positive pregnancy test at screening.
- •Acute illness or concomitant medication occurs from screening to pre-first-dose.
- •Cannot tolerate high-fat meal (applies only to subjects in the food-effect sub-study).
- •Difficulty swallowing, intolerance to venipuncture, or history of needle-syncope or blood-syncope.
- •Investigator judges that the subject is unsuitable for this study for any other reason.
研究组 & 干预措施
Placebo
Placebo Comparator
Healthy participants receive oral placebo capsules matching TUL321 capsules in Part 1 and Part 2, administered in parallel with TUL321 treatment cohorts as control.
干预措施: Part2: Placebo (Drug)
TUL321
Experimental
Healthy participants take oral TUL321 capsules: Part1 single ascending doses, Part2 multiple daily doses to assess safety, tolerability, PK, PD and food effect.
干预措施: Part1: TUL321 (Drug)
TUL321
Experimental
Healthy participants take oral TUL321 capsules: Part1 single ascending doses, Part2 multiple daily doses to assess safety, tolerability, PK, PD and food effect.
干预措施: Part2: TUL321 (Drug)
Placebo
Placebo Comparator
Healthy participants receive oral placebo capsules matching TUL321 capsules in Part 1 and Part 2, administered in parallel with TUL321 treatment cohorts as control.
干预措施: Part1: Placebo (Drug)
结局指标
主要结局
1.Incidence of adverse events (AEs) 2.Changes from baseline in physical examinations, vital signs, electrocardiograms (ECG), and laboratory tests
时间窗: up to 17 days
次要结局
- Peak plasma concentration (Cmax)(Pre-dose to 144 hours post-dose)
- Time to maximum plasma concentration (Tmax)(Pre-dose to 144 hours post-dose)
- Cumulative amount excreted（Ae）in urine(Pre-dose to 144 hours post-dose)
- Cumulative amount excreted（Ae）in feces(Pre-dose to 144 hours post-dose)
- Alternative pathway (AP) activity(Pre-dose to 144 hours post-dose)
- Bb concentration(Pre-dose to 144 hours post-dose)
研究者
研究点 (2)
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