| Eligibility |
Inclusion Criteria: Subjects will be eligible for inclusion in the study if they meet all
of the following criteria:
1. Able and willing to provide written informed consent to participate in this study
after reading the participant information sheet and Informed Consent Form (ICF) and
having the opportunity to discuss the study with the Investigator or designee.
2. Male and female subjects, self-reporting as white, 18-55 years of age, inclusive, at
the time of signing the ICF.
3. Subjects must weigh at least 50 kg (110 pounds) and have a body mass index 18-30
kg/m2, inclusive, at Screening and on Day -1.
4. Female subjects must not be lactating, and women of childbearing potential must have a
negative serum pregnancy test at Screening and a negative urine pregnancy test within
24 hours prior to receiving the first dose of IMP or IMP Test Products.
5. Female subjects of childbearing potential and male subjects with a partner of
childbearing potential must agree to use 2 effective methods of contraception (in
female subjects, one method must be highly effective). Full details of contraception
in Section 4.6.5.
6. In the Investigator's opinion, the subject must be able to understand the nature of
the study and any risks involved in participation and be willing to cooperate and
comply with the protocol restrictions and requirements.
Exclusion Criteria: Any subject meeting any of the following criteria will not qualify for
enrolment in the study:
1. Presence or history of any hepatobiliary disease at Screening, determined clinically
significant by the Investigator after discussion with the Sponsor's Responsible
Physician. Current, or history of, clinically significant (in the opinion of the
Investigator AND Sponsor's Responsible Physician) neurological conditions, endocrine,
thyroid, respiratory, gastrointestinal, renal, or cardiovascular disease, or history
(within the last 2 years) of any clinically significant psychiatric/psychotic illness
disorder (including anxiety, depression, and reactive depression).
2. Clinically relevant abnormal medical history, physical findings, or laboratory values
at Screening or Day-1 that could interfere with the objectives of the study or the
safety of the subjects, in the opinion of the Investigator.
3. A history of gastrointestinal surgery known to affect the absorption, metabolism, or
excretion of the IMP or IMP Test Products such as bariatric surgery or removal of part
of the bowel. A history of appendicectomy and hernia repair/herniorrhaphy/hernioplasty
is permitted for inclusion in the study.
4. Family history of long or short QT syndrome, hypokalemia, syncope, or Torsades de
Pointes.
5. Clinically significant 12-lead electrocardiogram (ECG) abnormalities, including
subjects with corrected QC interval (QTc) using Fridericia's formula >450 ms (male)
and >470 ms (female), at Screening or Day -1. A repeat assessment is allowed at each
visit. If the repeat measurement is in range, the subject may be included.
6. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 1.5 the upper limit
of normal (ULN) reference range, or bilirubin = 1.5 ULN at screening or Day-1. A
repeat assessment is allowed at each visit. If the repeat measurement is in range, the
subject may be included.
7. Systolic blood pressure outside the range of 90-145 mmHg, diastolic blood pressure
outside the range of 50-95 mmHg, or pulse rate outside the range of 50-100 bpm, taken
in the supine position at Screening or Day -1. A repeat assessment is allowed at each
visit. If the repeat measurement is in range, the subject may be included.
8. Receipt of any prescribed of nonprescribed systemic or topical medication within 30
days (or, if relevant, 5 half-lives, whichever is longer) prior to the first dose of
study drugs unless, in the opinion of the Investigator and Sponsor, the medication
will not interfere with the study procedures or compromise subject safety.
1. Occasional use of paracetamol (acetaminophen) for mild analgesia is permitted.
2. Vitamins and herbal supplements are not permitted 14 days prior to dosing
9. Presence or history of severe adverse reaction or allergy to food or any drug or
excipient or other allergy that is of clinical significance to the study drugs.
10. Previous receipt of MT-7117.
11. First-degree relative with a history of familial melanoma.
12. Previous use of afamelanotide or melanotan.
13. Female subjects planning to donate eggs (during the study and for 3 months after the
last visit).
14. Positive test for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C
antibody, or human immunodeficiency virus (HIV) 1 or HIV 2 antibodies at Screening.
15. Presence or history of drug abuse (as defined by Diagnostic and Statistical Manual of
Mental Disorders criteria), or a positive urine test for drugs of abuse at Screening
or Day -1.
16. Presence or history (in the last 2 years) of alcohol abuse or excessive alcohol
consumption, defined as subjects who regularly, or on average, drink more than 21
units (168 g) for males or 14 units (112 g) for females, of alcohol per week (1 unit
is equivalent to 8 g of alcohol).
17. Use of tobacco or nicotine-containing products (snuff, chewing tobacco, cigarettes,
cigars, pipes, e-cigarettes, or nicotine replacement products) within 3 months prior
to dosing, or a positive urine cotinine test at Screening or Day -1.
18. Consumption of food or drink containing oranges, grapefruit, liquorice, or cranberry
within the 7 days prior to the first dose of study drug.
19. Subjects who are not willing to abstain from consumption of caffeine and
methylxanthine (e.g., coffee, tea, cola, energy drinks, or chocolates) in the 48 hours
before Day -1 until completion of the post-treatment assessments and in the 48 hours
before the Follow-up/End of Study Visit.
20. Donation of 1 or more units of blood (450 mL) in the 3 months prior to Screening,
plasma in the 7 days prior to Screening, platelets in the 6 weeks prior to Screening,
or the intention to donate blood within 3 months after the last scheduled visit.
21. Heavy physical training, labor, or excessive exercise (e.g., long-distance running,
weightlifting, or any physical activity to which the subject is not accustomed) from 3
days before the administration of study drugs.
22. Participation in more than 3 clinical studies* involving administration of an IMP in
the previous year, or any study* involving administration of an IMP within 8 weeks
(or, if relevant, 5 half-lives, whichever is longer) prior to the first dose of study
drug.
*Disregarding any study Follow-up Periods.
23. Subjects with the presence of a skin lesion suspicious for dysplastic nevus or a
history of histologically proven dysplastic nevus.
24. Subjects who have any active malignancy (including melanoma) or history of significant
malignancy (including melanoma).
25. Subjects who have had Coronavirus Disease 2019 (COVID-19) in the 3 months prior to
Screening; or suspected active COVID-19 infection, a positive COVID-19 test, contact
with an individual with known COVID-19, or travel to an area with a high risk of
COVID-19 infection within 14 days of Screening.
26. Subjects that test positive for COVID-19 at Screening (Parts 3 and 4) or Day -1 (Parts
1-4).
27. Subjects who have received a COVID-19 vaccination within 14 days of Day 1. COVID-19
vaccination is not permitted during the study. Subjects may not take part in the study
if they have started but not completed a COVID-19 vaccination course at the time of
Screening or Day -1.
28. Subjects who have a history of major surgery within 3 months of Day 1.
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