HealthyPhase 1NCT06667765
A Study of RPT1G After Single and Multiple Doses in Healthy Adult Participants
A Phase 1 study testing RPT1G in people with Healthy, run by Remedy Plan, Inc. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- RPT1G
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteAustralia
- Study dates
- 18 Nov 2024to 14 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- 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.
- 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.
Who cannot join
- 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.
Show all 25Show fewer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Known history of allergy to any component of study intervention, including excipient(s).
- Individuals with LFTs > 1.5x ULN.
- Individuals who, in the opinion of the Investigator (or designee), should not participate in this study.
- Individuals who have already been enrolled and dosed on this study.
Trial locations and contacts
1 site in 1 country.
Australia1 site
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, 5000
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RPT1G After Single and Multiple Doses in Healthy Adult Participants
This is a first-in-human (FIH), randomized, double-blind, placebo-controlled, single and multiple dose study with staggered dose escalations in healthy participants.
Read the detailed description
Single-Ascending Dose (SAD) Cohorts: Cohorts 1-4:
Up to 32 participants will be enrolled in this arm. On Day 1, all participants will receive a single oral dose of RPT1G or placebo, in the fasted state, as well as post-dose safety, PK, and PD assessments up to Day 4 (72 hours post-dose).
Multiple-Ascending Dose (MAD) Cohorts: Cohorts 5-7:
Up to 18 participants will be enrolled in this arm. On Day 1, all participants will begin twice daily (BID [i.e., every 12 hours]) multiple oral dose administration of RPT1G or placebo in the fasted state for 5 days as well as safety, PK, and/or PD assessments throughout the study intervention administration period and up to Day 8 (72 hours after last dose).
- Conditions
- Healthy
- Being tested
- RPT1G, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RPT1GDrug
Dose formulation- Oral capsule
PlaceboDrug
Dose formulation- Oral capsule
| Study group | Role | What they receive |
|---|---|---|
| RPT1G Single ascending dose (SAD) cohort | Experimental | All participants will receive single oral dose of RPT1G or placebo in fasted state Receives: 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 Receives: Drug: RPT1G; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety of RPT1G by number of adverse events in accordance with CTCAE V5
Measured: 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
Maximum Plasma Concentration (Cmax)
Measured: Up to 8 days post first dose administration
To evaluate the pharmacokinetics (PK) of RPT1G
Time taken for maximum plasma concentration (Tmax)
Measured: Up to 8 days post first dose administration
To evaluate the pharmacokinetics (PK) of RPT1G
Area under the concentration-time curve (AUC)
Measured: Up to 8 days post first dose administration
To evaluate the pharmacokinetics (PK) of RPT1G
Apparent total body clearance (CL/F)
Measured: Up to 8 days post first dose administration
To evaluate the pharmacokinetics (PK) of RPT1G
Terminal half-life (T1/2)
Measured: Up to 8 days post first dose administration
To evaluate the pharmacokinetics (PK) of RPT1G
Apparent total volume of distribution (VZ/F)
Measured: Up to 8 days post first dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start18 Nov 2024
- Primary completion14 May 2025
- Study completion14 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Remedy Plan, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Remedy Plan Australia Pty. Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667765
- Sponsor's protocol ID
- RPT1G
- Status last verified
- May 2025
- First submitted
- 30 Oct 2024
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RPT1G After Single and Multiple Doses in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06667765
- Acronym / sponsor ID
- RPT1G
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Remedy Plan, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Remedy Plan Australia Pty. Ltd.
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 14 May 2025 (actual)
- Study completion
- 14 May 2025 (actual)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a first-in-human (FIH), randomized, double-blind, placebo-controlled, single and multiple dose study with staggered dose escalations in healthy participants.
Detailed description
Single-Ascending Dose (SAD) Cohorts: Cohorts 1-4:
Up to 32 participants will be enrolled in this arm. On Day 1, all participants will receive a single oral dose of RPT1G or placebo, in the fasted state, as well as post-dose safety, PK, and PD assessments up to Day 4 (72 hours post-dose).
Multiple-Ascending Dose (MAD) Cohorts: Cohorts 5-7:
Up to 18 participants will be enrolled in this arm. On Day 1, all participants will begin twice daily (BID [i.e., every 12 hours]) multiple oral dose administration of RPT1G or placebo in the fasted state for 5 days as well as safety, PK, and/or PD assessments throughout the study intervention administration period and up to Day 8 (72 hours after last dose).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RPT1G Single ascending dose (SAD) cohort | Experimental | Drug: RPT1G, Drug: PlaceboAll participants will receive single oral dose of RPT1G or placebo in fasted state |
| RPT1G Multiple ascending dose (MAD) cohort | Experimental | Drug: RPT1G, Drug: PlaceboAll participants will receive twice daily oral doses of RPT1G or placebo in a fasted state for 5 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
- 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.
Key exclusion criteria (25 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RPT1GDose formulation- Oral capsule | Drug | RPT1G Multiple ascending dose (MAD) cohort, RPT1G Single ascending dose (SAD) cohort |
| PlaceboDose formulation- Oral capsule | Drug | RPT1G Multiple ascending dose (MAD) cohort, RPT1G Single ascending dose (SAD) cohort |
Primary outcome
To assess the safety of RPT1G by number of adverse events in accordance with CTCAE V5
Time frame: SAD-Day 1 to Day 8 post first dose administration; MAD- Day1 to Day 12 post first dose administration
6 secondary outcomes
To evaluate the pharmacokinetics (PK) of RPT1G
Time frame: Up to 8 days post first dose administration
To evaluate the pharmacokinetics (PK) of RPT1G
Time frame: Up to 8 days post first dose administration
To evaluate the pharmacokinetics (PK) of RPT1G
Time frame: Up to 8 days post first dose administration
To evaluate the pharmacokinetics (PK) of RPT1G
Time frame: Up to 8 days post first dose administration
To evaluate the pharmacokinetics (PK) of RPT1G
Time frame: Up to 8 days post first dose administration
To evaluate the pharmacokinetics (PK) of RPT1G
Time frame: Up to 8 days post first dose administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
Trained vs. Untrained: Lower Extremity Pressure Changes
Trained Athletes, Untrained
Not yet recruitingPhase 1
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
Healthy Participants
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingPhase 1
A Study of Single and Multiple Subcutaneous or Intravenous Doses of ADX-001 in Healthy Adults to Assess Safety, Effects, and Immune Response
Healthy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RPT1G in people with Healthy, run by Remedy Plan, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety of RPT1G by number of adverse events in accordance with CTCAE V5 (time frame: SAD-Day 1 to Day 8 post first dose administration; MAD- Day1 to Day 12 post first dose administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.