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Search / Trial NCT06667765

A Study of RPT1G After Single and Multiple Doses in Healthy Adult Participants

Launched by REMEDY PLAN, INC. · Oct 30, 2024

Trial Information

Current as of July 21, 2025

Active, not recruiting

Keywords

ClinConnect Summary

This clinical trial, called "A Study of RPT1G After Single and Multiple Doses in Healthy Adult Participants," is testing a new treatment called RPT1G in healthy adults. The study is in its first phase and aims to understand how the medication works in the body after giving it to participants once and several times. It is designed as a randomized, double-blind trial, which means that neither the participants nor the researchers know who is receiving the actual treatment or a placebo (a sugar pill).

To be eligible for this trial, participants must be between 18 and 55 years old, weigh at least 48 kg (about 106 lbs), and be in good health without any serious medical issues. They will need to stay at the research unit for a certain period during the study. Participants can expect to undergo several assessments, including physical exams and lab tests, to ensure their safety throughout the trial. It’s important to know that females must not be pregnant and must follow specific contraception guidelines, while males must also adhere to contraception rules. This study is currently recruiting participants, and those interested should discuss it with their healthcare provider for more information.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Must be able to understand and provide written informed consent prior to initiation of study procedures, able to abide by the study restrictions, and remain confined in the research unit as required.
  • 2. Must be ≥ 18 and ≤ 55 years of age, at Screening.
  • 3. Have a body weight ≥ 48 kg (105.6 lbs) and body mass index (BMI) ≥ 18.0 and \< 32.0 kg/meter square at Screening, with no clinically significant change in body weight at Check-in as determined by the Investigator.
  • 4. Must be in good health and without clinically significant abnormalities as assessed by review of medical and surgical history, physical examination, vital signs measurement, ophthalmoscopic assessment, and 12-lead ECG at Screening and Check-in as assessed by the Investigator.
  • 5. Laboratory evaluations or laboratory parameters are within the reference range (laboratory parameters outside the reference range may be included only if the Investigator considers that the findings are not clinically significant and agreement by the Sponsor's Medical Monitor is obtained, and inclusion of the participant will not introduce additional risk factors and will not interfere with the study procedures) at Screening and Check-in. One additional repeat laboratory evaluation may be permitted at the Investigator's discretion.
  • 6. Female participants are eligible to enroll and participate in the study if they meet the definition of non-childbearing potential. Women of childbearing potential (WOCBP) can enroll if they have a negative serum pregnancy test result at Screening and agree to comply with the contraception requirements of the protocol. A pregnancy test must also be performed within 72 hours before Day 1 of study dosing.
  • 7. Male participants are eligible to enroll if they agree to comply with the contraception requirements of the protocol.
  • 8. Male participants must agree to not donate sperm during participation in the study starting at Screening and for 3 months following the administration of the last study dose. Female participants must refrain from donating ova and/or breastfeeding during participation in the study and for 30 days following the administration of the last study dose.
  • Exclusion Criteria:
  • 1. Participant is an employee of the Sponsor, including employees contracted by the Sponsor (i.e., consultants) or an employee of the contract research organization (CRO), or an employee of the site/institution.
  • 2. Any sign or symptom that may indicate an active infection.
  • 3. History of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to Check-in.
  • 4. Hospitalization within 2 months prior to Check-in or major surgical procedure (per Investigator's discretion) of any type within 3 months prior to Check- in.
  • 5. Significant history or clinical manifestation of any metabolic, allergic, autoimmune, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, ocular, oncologic ( concurrent malignancy or a history of malignancy during the past 5 years, except for basal cell or 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 study results, including any condition that would affect drug absorption, distribution, metabolism, or excretion of drugs (e.g., stomach or intestinal surgery, or gallbladder removal/cholecystectomy; uncomplicated appendectomy and hernia repair will be allowed).
  • 6. Prior treatment with a nicotinamide phosphoribosyltransferase (NAMPT) inhibitor.
  • 7. Use of immunosuppressant therapies or chemotherapy agents or steroids (topical or intranasal steroids for the treatment of hay fever are permissible) within 3 months prior to Screening.
  • 8. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
  • 9. Individuals with congenital nonhemolytic hyperbilirubinemia (e.g., suspicion of Gilbert's syndrome based on total and direct bilirubin).
  • 10. Screening or Check-in 12-lead ECG shows:
  • 1. Prolonged corrected QT interval by Fridericia's method (QTcF) (i.e., QTcF \> 450 ms for males and \> 470 ms for females)
  • 2. Other clinically significant abnormalities.
  • 11. Estimated creatinine clearance \< 90 mL/min using the Cockcroft-Gault equation at Screening or Check-in.
  • 12. Positive pregnancy test or is lactating (WOCBP) at Screening or Check-in.
  • 13. 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.
  • 14. 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 the CRU or positive urine alcohol test result at Check-in. Use of more than 10 tobacco or nicotine containing products (including e-vapor products) per week, or use of any marijuana containing products within 4 weeks prior to Check-in, or positive cotinine at Screening or Check-in. Positive urine drug screen at Screening or Check-in. For each test, one repeat test may be permitted at the Investigator's discretion.
  • 15. Has participated in any investigational study intervention trial in which receipt of an investigational study intervention occurred within 30 days prior to Check-in or 5 half-lives of the investigational intervention's PK, PD, or biological activity (if known), whichever is longer, or is currently participating in another clinical study.
  • 16. Use or intent to use any medications within 30 days or 5 half-lives (whichever is longer) prior to Check-in, unless deemed acceptable by the Investigator (or designee) with agreement by the Medical Monitor.
  • 17. Use or intent to use natural products or nutritional/dietary supplements (including St. John's wort), vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations 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) with agreement by the Sponsor's Medical Monitor.
  • 18. Ingestion of Seville/blood oranges, grapefruit, grapefruit hybrids, or marmalade or fruit juice products made from Seville/blood oranges, grapefruit or grapefruit hybrids within 7 days prior to Check-in per the Investigator's discretion.
  • 19. Poor peripheral venous access, receipt of blood products within 2 months prior to Checkin, loss or donation of more than 400mL of blood or blood products during the 8 weeks prior to Check-in, or donation of any blood or blood products during the 2 weeks prior to Check-in.
  • 20. Known history of allergy to any component of study intervention, including excipient(s).
  • 21. Individuals with LFTs \> 1.5x ULN.
  • 22. Individuals who, in the opinion of the Investigator (or designee), should not participate in this study.
  • 23. Individuals who have already been enrolled and dosed on this study.

About Remedy Plan, Inc.

Remedy Plan, Inc. is a leading clinical trial sponsor dedicated to advancing innovative therapies and treatments across various medical fields. With a commitment to improving patient outcomes, the company specializes in designing and implementing robust clinical studies that adhere to the highest ethical and regulatory standards. Remedy Plan, Inc. leverages cutting-edge technology and a patient-centric approach to streamline the trial process, ensuring efficient data collection and analysis. Their experienced team collaborates with healthcare professionals, regulatory bodies, and patients to facilitate the development of safe and effective medical solutions that address unmet clinical needs.

Locations

Adelaide, South Australia, Australia

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported