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

NCT06994286 | Completed Phase 1 FDA Drug

• 1 other identifier: MT-7117-Z-104
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (12)

• Maximum plasma concentration (Cmax) of MT-7117.

  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.

  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)

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

  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)

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

  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)

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

  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)

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

  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)

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

  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)

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

  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)

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

  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)

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

  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)

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

  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)

• Mean residence time (MRT) of MT-7117.

  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)

Secondary Outcomes (1)

• 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).

Study Arms (6)

Cohort A-1:MT-7117 100 mg

ACTIVE COMPARATOR

single oral dose

Drug: MT-7117

Cohort A-1:Placebo

PLACEBO COMPARATOR

single oral dose

Drug: Placebo

Cohort A-2:MT-7117 300mg

ACTIVE COMPARATOR

single oral dose

Drug: MT-7117

Cohort A-2:Placebo

PLACEBO COMPARATOR

single oral dose

Drug: Placebo

Cohort B-1:MT-7117 200mg

ACTIVE COMPARATOR

single dose followed by once-daily oral dosing

Drug: MT-7117

Cohort B-1:Placebo

PLACEBO COMPARATOR

single dose followed by once-daily oral dosing

Drug: Placebo

Interventions

MT-7117 DRUG

Oral

Also known as: Dersimelagon

Cohort A-1:MT-7117 100 mg; Cohort A-2:MT-7117 300mg; Cohort B-1:MT-7117 200mg

Placebo DRUG

Oral

Cohort A-1:Placebo; Cohort A-2:Placebo; Cohort B-1:Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Presence or history of drug abuse, or a positive urine test for drugs of abuse at Screening or Day -1.
• 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 -1. 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 -1. 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 -1.

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

Location

Study Officials

• General Manager

  Tanabe Pharma Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 29, 2025
• Study Start: June 24, 2025
• Primary Completion: July 21, 2025
• Study Completion: August 4, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)