Phase
Condition
N/ATreatment
Placebo
RPT1G
Clinical Study ID
Ages 18-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Must be able to understand and provide written informed consent prior to initiationof study procedures, able to abide by the study restrictions, and remain confined inthe research unit as required.
Must be ≥ 18 and ≤ 55 years of age, at Screening.
Have a body weight ≥ 48 kg (105.6 lbs) and body mass index (BMI) ≥ 18.0 and < 32.0kg/meter square at Screening, with no clinically significant change in body weightat Check-in as determined by the Investigator.
Must be in good health and without clinically significant abnormalities as assessedby review of medical and surgical history, physical examination, vital signsmeasurement, ophthalmoscopic assessment, and 12-lead ECG at Screening and Check-inas assessed by the Investigator.
Laboratory evaluations or laboratory parameters are within the reference range (laboratory parameters outside the reference range may be included only if theInvestigator considers that the findings are not clinically significant andagreement by the Sponsor's Medical Monitor is obtained, and inclusion of theparticipant will not introduce additional risk factors and will not interfere withthe study procedures) at Screening and Check-in. One additional repeat laboratoryevaluation may be permitted at the Investigator's discretion.
Female participants are eligible to enroll and participate in the study if they meetthe definition of non-childbearing potential. Women of childbearing potential (WOCBP) can enroll if they have a negative serum pregnancy test result at Screeningand agree to comply with the contraception requirements of the protocol. A pregnancytest must also be performed within 72 hours before Day 1 of study dosing.
Male participants are eligible to enroll if they agree to comply with thecontraception requirements of the protocol.
Male participants must agree to not donate sperm during participation in the studystarting at Screening and for 3 months following the administration of the laststudy dose. Female participants must refrain from donating ova and/or breastfeedingduring participation in the study and for 30 days following the administration ofthe last study dose.
Exclusion
Exclusion Criteria:
Participant is an employee of the Sponsor, including employees contracted by theSponsor (i.e., consultants) or an employee of the contract research organization (CRO), or an employee of the site/institution.
Any sign or symptom that may indicate an active infection.
History of chronic or recurrent infections, or a serious or life-threateninginfection within the 6 months prior to Check-in.
Hospitalization within 2 months prior to Check-in or major surgical procedure (perInvestigator's discretion) of any type within 3 months prior to Check- in.
Significant history or clinical manifestation of any metabolic, allergic,autoimmune, dermatological, hepatic, renal, hematological, pulmonary,cardiovascular, gastrointestinal, neurological, ocular, oncologic ( concurrentmalignancy or a history of malignancy during the past 5 years, except for basal cellor squamous cell carcinoma-in-situ of the skin that have been successfully excised,or ablated, with no evidence of metastatic disease for 3 years), respiratory,endocrine, or psychiatric disorder, as determined by the Investigator (or designee)that would jeopardize the safety of the individual or the validity of the studyresults, including any condition that would affect drug absorption, distribution,metabolism, or excretion of drugs (e.g., stomach or intestinal surgery, orgallbladder removal/cholecystectomy; uncomplicated appendectomy and hernia repairwill be allowed).
Prior treatment with a nicotinamide phosphoribosyltransferase (NAMPT) inhibitor.
Use of immunosuppressant therapies or chemotherapy agents or steroids (topical orintranasal steroids for the treatment of hay fever are permissible) within 3 monthsprior to Screening.
History of significant hypersensitivity, intolerance, or allergy to any drugcompound, food, or other substance, unless approved by the Investigator (ordesignee).
Individuals with congenital nonhemolytic hyperbilirubinemia (e.g., suspicion ofGilbert's syndrome based on total and direct bilirubin).
Screening or Check-in 12-lead ECG shows:
Prolonged corrected QT interval by Fridericia's method (QTcF) (i.e., QTcF > 450ms for males and > 470 ms for females)
Other clinically significant abnormalities.
Estimated creatinine clearance < 90 mL/min using the Cockcroft-Gault equation atScreening or Check-in.
Positive pregnancy test or is lactating (WOCBP) at Screening or Check-in.
Has a positive test for human immunodeficiency virus (HIV)-1 or HIV-2 antibodies,hepatitis panel (Hepatitis B surface antibody [HBsAb], Hepatitis B core antibody [HBcAb], and Hepatitis C virus antibody [HCVAb]) or tuberculosis (TB) blood test (e.g., QuantiFERON TB Gold Plus test) at Screening.
Use or history of the following: History of alcoholism or drug/chemical abuse within 2 years prior to Check-in. Any use of alcohol within 48 hours of admission to theCRU or positive urine alcohol test result at Check-in. Use of more than 10 tobaccoor nicotine containing products (including e-vapor products) per week, or use of anymarijuana containing products within 4 weeks prior to Check-in, or positive cotinineat Screening or Check-in. Positive urine drug screen at Screening or Check-in. Foreach test, one repeat test may be permitted at the Investigator's discretion.
Has participated in any investigational study intervention trial in which receipt ofan investigational study intervention occurred within 30 days prior to Check-in or 5half-lives of the investigational intervention's PK, PD, or biological activity (ifknown), whichever is longer, or is currently participating in another clinicalstudy.
Use or intent to use any medications within 30 days or 5 half-lives (whichever islonger) prior to Check-in, unless deemed acceptable by the Investigator (ordesignee) with agreement by the Medical Monitor.
Use or intent to use natural products or nutritional/dietary supplements (includingSt. John's wort), vitamins, minerals, and phytotherapeutic/herbal/plant-derivedpreparations within or received within 14 days or 5 half-lives (whichever is longer)prior to Check-in, unless deemed acceptable by the Investigator (or designee) withagreement by the Sponsor's Medical Monitor.
Ingestion of Seville/blood oranges, grapefruit, grapefruit hybrids, or marmalade orfruit juice products made from Seville/blood oranges, grapefruit or grapefruithybrids within 7 days prior to Check-in per the Investigator's discretion.
Poor peripheral venous access, receipt of blood products within 2 months prior toCheckin, loss or donation of more than 400mL of blood or blood products during the 8weeks prior to Check-in, or donation of any blood or blood products during the 2weeks prior to Check-in.
Known history of allergy to any component of study intervention, includingexcipient(s).
Individuals with LFTs > 1.5x ULN.
Individuals who, in the opinion of the Investigator (or designee), should notparticipate in this study.
Individuals who have already been enrolled and dosed on this study.
Study Design
Study Description
Connect with a study center
CMAX Clinical Research Pty Ltd
Adelaide, South Australia 5000
AustraliaSite Not Available
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