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

NCT06667765 | Completed Phase 1 DMC

• 1 other identifier: RPT1G
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This is a first-in-human (FIH), randomized, double-blind, placebo-controlled, single and multiple dose study with staggered dose escalations in healthy participants.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• To assess the safety of RPT1G by number of adverse events in accordance with CTCAE V5

  SAD-Day 1 to Day 8 post first dose administration; MAD- Day1 to Day 12 post first dose administration

Secondary Outcomes (6)

• To evaluate the pharmacokinetics (PK) of RPT1G

  Up to 8 days post first dose administration

• To evaluate the pharmacokinetics (PK) of RPT1G

  Up to 8 days post first dose administration

• To evaluate the pharmacokinetics (PK) of RPT1G

  Up to 8 days post first dose administration

• To evaluate the pharmacokinetics (PK) of RPT1G

  Up to 8 days post first dose administration

• To evaluate the pharmacokinetics (PK) of RPT1G

  Up to 8 days post first dose administration

Study Arms (2)

RPT1G Single ascending dose (SAD) cohort

EXPERIMENTAL

All participants will receive single oral dose of RPT1G or placebo in fasted state

Drug: RPT1G; Drug: Placebo

RPT1G Multiple ascending dose (MAD) cohort

EXPERIMENTAL

All participants will receive twice daily oral doses of RPT1G or placebo in a fasted state for 5 days

Drug: RPT1G; Drug: Placebo

Interventions

RPT1G DRUG

Dose formulation- Oral capsule

RPT1G Multiple ascending dose (MAD) cohort; RPT1G Single ascending dose (SAD) cohort

Placebo DRUG

Dose formulation- Oral capsule

RPT1G Multiple ascending dose (MAD) cohort; RPT1G Single ascending dose (SAD) cohort

Eligibility Criteria

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

You may qualify if:

• 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.
• 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 \< 32.0 kg/meter square at Screening, with no clinically significant change in body weight at Check-in as determined by the Investigator.
• 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.
• 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.
• Male participants are eligible to enroll if they agree to comply with the contraception requirements of the protocol.
• 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.

You may not qualify if:

• 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.
• Any sign or symptom that may indicate an active infection.
• History of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to Check-in.
• 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.
• 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).
• Prior treatment with a nicotinamide phosphoribosyltransferase (NAMPT) inhibitor.
• 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.
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
• Individuals with congenital nonhemolytic hyperbilirubinemia (e.g., suspicion of Gilbert'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 \> 450 ms for males and \> 470 ms for females)
• Other clinically significant abnormalities.
• Estimated creatinine clearance \< 90 mL/min using the Cockcroft-Gault equation at Screening 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.

Sponsors & Collaborators

• Remedy Plan, Inc.: lead
• Remedy Plan Australia Pty. Ltd.: collaborator

Study Sites (1)

CMAX Clinical Research Pty Ltd

Adelaide, South Australia, 5000, Australia

Location

Study Design

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

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: October 31, 2024
• Study Start: November 18, 2024
• Primary Completion: May 14, 2025
• Study Completion: May 14, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)