临床试验/NCT06994286

NCT06994286已完成1 期

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of Single and Multiple Doses of MT-7117 in Chinese Healthy Subjects

Tanabe Pharma Corporation2 个研究点分布在 1 个国家目标入组 40 人开始时间: 2025年6月24日最近更新: 2026年4月3日

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Tanabe Pharma Corporation
入组人数: 40
试验地点: 2
主要终点: Maximum plasma concentration (Cmax) of MT-7117.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of MT-7117 in Chinese healthy subjects.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
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 55 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Male Chinese subjects or female Chinese subjects.
•Subjects are aged 18 to 55 years, inclusive, at the time of informed consent.
•Subjects must weigh at least 50 kg and have a body mass index (BMI) 19.0 to 26.0 kg/m2 both inclusive at Screening and Day -
•Subjects must have acceptable clinical conditions in the opinion of the Investigator based upon the results of medical history, physical examination, clinical laboratory tests (biochemistry, hematology, coagulation, and urinalysis), vital signs and a 12-lead ECG at Screening and Day -
•Subjects are able to provide written informed consent to participate in this study after reading Informed Consent Form (ICF), and after having the opportunity to discuss the study with the Investigator or designee.
•In the Investigator's opinion, subjects are able to understand the nature of the study and any risks involved in participation, and willing to cooperate and comply with the protocol restrictions and requirements.

排除标准

•Subjects with presence and history of any clinically significant (in the opinion of the Investigator) cardiac, hepatobiliary, renal, gastrointestinal, respiratory, psychiatric/neurological, hematopoietic, endocrine, or skin disease.
•Subjects with Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT) >=1.5 × upper limit of normal (ULN) and/or total bilirubin >ULN at Screening or Day -
•Subjects who have a family history of long or short QT syndrome, hypokalemia, syncope, or Torsades de Pointes.
•Subjects with clinically significant 12-lead ECG abnormalities or a QT interval corrected for heart rate using Fridericia's formula (QTcF) >450 msec (male) and >470 msec (female), at Screening or Day -
•Systolic blood pressure (SBP) outside the range of 90-140 mmHg, diastolic blood pressure (DBP) outside the range of 50-90 mmHg, or pulse rate outside the range of 50-100 bpm, taken in the sitting position at Screening or Day -
•Presence or history of severe adverse reaction or allergy to any drug or food.
•Donation or hemorrhage of 400 mL or more of blood within 12 weeks prior to Screening, or 200 mL or more of blood within 4 weeks prior to Screening.
•Subjects who have a positive test for serologic reactions for syphilis, Hepatitis B surface (HBs) antigen, Hepatitis B core (HBc) antibody, Hepatitis C virus (HCV) antibody, or HIV antibody/antigen at Screening.
•Presence or history of drug abuse, or a positive urine test for drugs of abuse at Screening or Day -
•Presence or history (in the last two years) of alcohol abuse, or intake of more than 28 units/224 g of alcohol weekly for males or 21 units/168 g of alcohol weekly for females or a positive test for alcohol at Screening or Day -
•One unit/8 g is equivalent to a half-pint (280 mL) of beer or one measure (25 mL) of spirits or one glass (125 mL) of wine.
•Subjects with presence or history of melanoma and/or presence or history of histologically confirmed dysplastic naevus.
•Subjects with a first-degree relative with history of familial melanoma.
•Subjects with Fitzpatrick skin type V or VI at Screening (only Part B).
•Subjects who have suntanned using tanning beds, phototherapy, or artificial tanning products within 3 months prior to the Day -
•Sunburn due to sunlight may be included in the study if the Investigator judges that there is no problem with the study evaluation.
•Subjects who used afamelanotide or melanotan within 6 months prior to the Day -
•Subjects who used beta-carotene, or any other medications or supplements which may affect skin color, as judged by the Investigator within 3 months prior to Day -
•Subjects who used any medication (including topical and herbal preparations) other than Investigational Medicinal Product (IMP) within 14 days (or 5 half-lives of the drug, whichever is longer) prior to the first dose of IMP.
•Subjects who consumed any health food containing St John's Wort within 14 days prior to the first dose of IMP.
•Subjects who consumed food or drink containing Seville oranges or grapefruit (including marmalade and fruit juices) within 7 days prior to the first dose of IMP.
•Subjects who use tobacco or nicotine-containing products (snuff, chewing tobacco, cigarettes, cigars pipes, e-cigarettes, or nicotine replacement products) within 3 months prior to the first dose of IMP, or positive urine cotinine test at Screening or Day -
•Subject who underwent surgery known to affect gastrointestinal absorption of the IMP (other than appendectomy and hernia repair/herniorrhaphy/hernioplasty).
•Subjects who have participated in another clinical study involving blood sample collection or administration of IMP within 12 weeks prior to informed consent.
•Subjects who have previously received MT-
•Female subjects who are pregnant (positive pregnancy test at Screening or Day -1) or lactating.
•Male subjects and female subjects of childbearing potential who don't agree to use contraception as defined in the protocol.
•Subjects the Investigator determined ineligible for the study.

研究组 & 干预措施

Cohort A-1:Placebo

Placebo Comparator

single oral dose

干预措施: Placebo (Drug)

Cohort A-2:Placebo

Placebo Comparator

single oral dose

干预措施: Placebo (Drug)

Cohort B-1:Placebo

Placebo Comparator

single dose followed by once-daily oral dosing

干预措施: Placebo (Drug)

Cohort A-1:MT-7117 100 mg

Active Comparator

single oral dose

干预措施: MT-7117 (Drug)

Cohort B-1:MT-7117 200mg

Active Comparator

single dose followed by once-daily oral dosing

干预措施: MT-7117 (Drug)

Cohort A-2:MT-7117 300mg

Active Comparator

single oral dose

干预措施: MT-7117 (Drug)

结局指标

主要结局

Maximum plasma concentration (Cmax) of MT-7117.

时间窗: PartA : pre-dose,0.5,1,2,3,4,5,6,8,12,24,48,96 hours (h) post-dose, PartB : Day1,18(pre-dose,0.5,1,2,3,4,5,6,8,12h post-dose), Day2, Day3, Day5,6,8to12,14,16 (before IMP), Day19:24h*, Day20:48h*, Day21:72h* (*after last IMP)

Time to maximum plasma concentration (tmax)of MT-7117.

Apparent plasma terminal elimination half-life (t1/2) of MT-7117.

Area under the plasma concentration-time curve from time zero to 24 hours (AUC0-24h) of MT-7117.

Area under the plasma concentration-time curve from time zero to 48 hours(AUC0-48h) of MT-7117.

Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-last) of MT-7117.

Area under the plasma concentration-time curve over the dosing interval (AUC0-τ) of MT-7117.

Area under the plasma concentration-time curve extrapolated from time zero to infinity (AUC0-∞).

Terminal elimination rate constant (kel) of MT-7117.

Apparent oral clearance (CL/F) of MT-7117.

Apparent volume of distribution during the terminal phase after oral administration (Vz/F) of MT-7117

Apparent volume of distribution at steady state (Vss/F) of MT-7117

Mean residence time (MRT) of MT-7117.

Maximum plasma concentration (Cmax) of MT-7117.

时间窗: PartA : pre-dose,0.5,3,4,5,6,8,12,24,48,96h post-dose, PartB : Day1,18(pre-dose,0.5,3,4,5,6,8,12h post-dose), Day2, Day3, Day5,6,8to12,14,16 (before IMP), Day19:24h*, Day20:48h*, Day21:72h* (*after last IMP)

Time to maximum plasma concentration (tmax)of MT-7117.

Apparent plasma terminal elimination half-life (t1/2) of MT-7117.

Area under the plasma concentration-time curve from time zero to 24 hours (AUC0-24h) of MT-7117.

Area under the plasma concentration-time curve from time zero to 48 hours(AUC0-48h) of MT-7117.

Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-last) of MT-7117.

Area under the plasma concentration-time curve over the dosing interval (AUC0-τ) of MT-7117.

Area under the plasma concentration-time curve extrapolated from time zero to infinity (AUC0-∞).

Terminal elimination rate constant (kel) of MT-7117.

Apparent oral clearance (CL/F) of MT-7117.

Apparent volume of distribution during the terminal phase after oral administration (Vz/F) of MT-7117

Mean residence time (MRT) of MT-7117.

次要结局

Number of subjects with Treatment-emergent Adverse events (AEs) (including serious AEs [SAEs] and hepatic AEs of special interest [AESIs]).(The time written informed consent is obtained from a subject until the end of the safety follow-up period or the withdrawal of the subject from the study (PartA), or until Day 21 or the withdrawal of the subject from the study (PartB).)

研究者

发起方

Tanabe Pharma Corporation

申办方类型

Industry

责任方

Sponsor

研究点 (2)

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