CompletedPhase 1

The Purpose of This Study is to Investigate the Safety, Tolerability and Pharmacokinetics of MT-7117 in Healthy Subjects.

China40 participantsStarted 2025-06-24

Plain-language summary

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

Who can participate

Age range18 Years – 55 Years

SexALL

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Inclusion criteria

✓. 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 -1.
✓. 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 -1.
✓. 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.

Exclusion criteria

✕. 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 -1.
✕. 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 -1.
✕. 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 -1.
✕. 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.

What they're measuring

Maximum plasma concentration (Cmax) of MT-7117.

Timeframe: 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.

Trial details

NCT IDNCT06994286

SponsorTanabe Pharma Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-21

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