Healthy VolunteerPhase 1NCT05667688
Pharmacokinetics and Pharmacodynamics Study of LBS-008 in Healthy Volunteers Aged 50-85
A Phase 1 study testing Tinlarebant (LBS-008) in people with Healthy Volunteer and Dry Age-related Macular Degeneration, run by RBP4 Pty Ltd at 1 site in Australia.
Trial summary
This is a Phase 1b, parallel single-dose study to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of Tinlarebant when administered as an oral dose to elderly healthy volunteers. This study will evaluate 2 dose levels in 2 cohorts comprising up to a total of 16 participants (8 per cohort). Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, Dry Age-related Macular Degeneration
- What is being tested?
- Tinlarebant (LBS-008)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteAustralia
- Study dates
- 28 Nov 2022to 18 Jan 2023
- 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
- Healthy adult male or female, or adult male or female with a stable chronic disease or condition aged 50-85 years of age, inclusive. Adults with stable chronic disease or condition includes adults with no new diagnosis, hospitalisation or changes in medication in the 3 months prior to first dose of study drug on Day 1. Ongoing concomitant medications associated with the stable disease or condition, including over-the-counter (OTC) medications and herbal/vitamin supplements taken by volunteers, will be recorded and reviewed by the PI (or delegate) to determine whether the volunteer is suitable for inclusion in the study. In conducting this review, the PI (or delegate) must consider Exclusion Criteria 11, 12, 13 and 14.
- The volunteer is considered by the Investigator to be in stable health
Who cannot join
- Presence of CS cardiovascular, pulmonary, hepatic, renal, haematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease, or any other condition that, in the opinion of the Investigator, would jeopardise the safety of the participant or the validity of the study results.
- Had a CS new illness within 1 month prior to the screening visit, with the exception of fully resolved gastrointestinal illness at least 14 days prior to the screening visit, fully resolved minor colds (e.g., only cold and flu-like symptoms) that occurred within 1 month prior to the screening visit, and fully resolved corona virus disease 2019 (COVID-19) infections if resolved at least 14 days prior to the screening visit and 30 days prior to confinement to the clinical facility.
- A history of uncontrolled hypertension, coronary artery disease, or any other significant cardiovascular disease.
- A history of uncontrolled diabetes. Volunteers with fully resolved gestational diabetes will be eligible to participate in the study.
- A history of unexplained loss of consciousness, epilepsy or other seizure disorder, or cerebrovascular disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1b, Open-Label, Parallel Single-Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Tinlarebant in Healthy Volunteers Aged 50-85
This is a Phase 1b, parallel single-dose study to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of Tinlarebant when administered as an oral dose to elderly healthy volunteers. This study will evaluate 2 dose levels in 2 cohorts comprising up to a total of 16 participants (8 per cohort). Dose levels will be evaluated in parallel.
Read the detailed description
This is a Phase 1b, parallel single-dose study to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of tinlarebant when administered as an oral dose to healthy volunteers aged 50-85. Tinlarebant (previously called LBS-008) is being developed as an oral treatment to slow or halt the progression of dry age-related macular degeneration (AMD) and juvenile onset macular degeneration, known as Stargardt disease (STGD). Accumulation of lipofuscin bisretinoids in the retina is associated with several retinal degenerative diseases including dry AMD and STGD. A total of up to 16 healthy volunteers aged 50-85 are planned to be enrolled into 2 cohorts (8 participants per cohort). Participants will receive a single oral dose of tinlarebant, either 5 mg (Cohort 1) or 10 mg (Cohort 2). The total maximum study duration for participants in this study is 45 days, inclusive of visit windows. This includes a screening period of up to 27 days (Day -28 to Day -2), confinement to the clinical facility over 2 nights (Day -1 to Day 2) and 5 outpatient visits including the EOS visit or Day 15. Tinlarebant will be administered in tablet form; a single tinlarebant tablet will contain 5 mg of IP. Participants in Cohort 1 will receive 1 tinlarebant tablet (5 mg dose) and participants in Cohort 2 will receive 2 tinlarebant tablets (10 mg dose). Enrolment and dosing of participants in Cohorts 1 and 2 may occur concurrently. Healthy volunteers aged 50-85, will be screened between Day -28 and Day -2, inclusive. Participants will be admitted to the clinical facility on Day -1 with tinlarebant dosing to occur on the following day (Day 1). All participants will be dosed under fasted conditions. Participants will be confined at the clinical facility from Day -1 through to Day 2 with discharge following completion of all PK and PD blood sample collections and other scheduled assessments on Day2. If participants experience any clinically significant (CS) AEs during the confinement period, they may remain in the clinical facility for further observation at the discretion of the Principal Investigator (PI). Blood samples for PK and PD analysis will be collected pre-dose and at timepoints up to 24 hours (Day 2) post-dose during the confinement period. Participants will be required to attend the clinic as outpatients on Days 3, 4, 6 and 8 for further safety assessments, PK and PD blood sampling. Participants will then return to the clinical facility for final safety assessments at an end of study (EOS) vision Day 15.
In the event of early study termination prior to the EOS visit (Day 15), participants will be requested to attend the clinic for an early termination (ET) visit.
- Being tested
- Tinlarebant (LBS-008)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tinlarebant (LBS-008)Drug
A single dose of Tinlarebant (LBS-008) will be administered to each study participant on study Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: 5 mg, fasted | Active comparator | A single dose (5 mg) of tinlarebant will be administered to each study participant on study Day 1. Receives: Drug: Tinlarebant (LBS-008) |
| Cohort 2: 10 mg, fasted | Active comparator | A single dose (10 mg) of tinlarebant will be administered to each study participant on study Day 1. Receives: Drug: Tinlarebant (LBS-008) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the pharmacokinetics (PK) of tinlarebant in plasma following a single oral dose in healthy volunteers aged 50-85.
Area under the plasma concentration versus time curve from time 0 to the last time point with quantifiable concentration (AUC0-t)
Measured: Up to 168 hours
To measure the pharmacokinetics (PK) of tinlarebant in plasma following a single oral dose in healthy volunteers aged 50-85.
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity (AUC0-inf)
Measured: Up to 168 hours
To measure the pharmacokinetics (PK) of tinlarebant in plasma following a single oral dose in healthy volunteers aged 50-85.
Maximum observed plasma concentration (Cmax)
Measured: Up to 168 hours
To measure the pharmacokinetics (PK) of tinlarebant in plasma following a single oral dose in healthy volunteers aged 50-85.
Time of maximum observed plasma concentration (Tmax)
Measured: Up to 168 hours
To measure the pharmacokinetics (PK) of tinlarebant in plasma following a single oral dose in healthy volunteers aged 50-85.
Apparent plasma terminal elimination half-life (t1/2)
Measured: Up to 168 hours
To measure the pharmacokinetics (PK) of tinlarebant in plasma following a single oral dose in healthy volunteers aged 50-85.
Terminal elimination rate constant (λz)
Measured: Up to 168 hours
To measure the pharmacokinetics (PK) of tinlarebant in plasma following a single oral dose in healthy volunteers aged 50-85.
Apparent total body clearance (CL/F)
Measured: Up to 168 hours
To measure the pharmacokinetics (PK) of tinlarebant in plasma following a single oral dose in healthy volunteers aged 50-85.
Apparent volume of distribution (Vz/F)
Measured: Up to 168 hours
To measure the concentrations of retinol-binding protein 4 (RBP4), a pharmacodynamic (PD) biomarker, in plasma following a single oral dose in healthy volunteers aged 50-85
Time of minimal RPB4 levels post-dose (Tmin)
Measured: Up to 168 hours
To measure the concentrations of retinol-binding protein 4 (RBP4), a pharmacodynamic (PD) biomarker, in plasma following a single oral dose in healthy volunteers aged 50-85
Maximal suppression to RBP4 expressed as minimum concentration of RBP4 (Cmin)
Measured: Up to 168 hours
To measure the concentrations of retinol-binding protein 4 (RBP4), a pharmacodynamic (PD) biomarker, in plasma following a single oral dose in healthy volunteers aged 50-85
Maximal suppression to RBP4 expressed as percent (%) of baseline concentration of RBP4 (C%bmin)
Measured: Up to 168 hours
To measure the concentrations of retinol-binding protein 4 (RBP4), a pharmacodynamic (PD) biomarker, in plasma following a single oral dose in healthy volunteers aged 50-85
Level of RBP4 at 12 hours as concentration (C12h)
Measured: Up to 168 hours
To measure the concentrations of retinol-binding protein 4 (RBP4), a pharmacodynamic (PD) biomarker, in plasma following a single oral dose in healthy volunteers aged 50-85
Level of RBP4 at 12 hours as percent of baseline concentration (C%b12h)
Measured: Up to 168 hours
To measure the concentrations of retinol-binding protein 4 (RBP4), a pharmacodynamic (PD) biomarker, in plasma following a single oral dose in healthy volunteers aged 50-85
Level of RBP4 at 24 hours as concentration (C24h)
Measured: Up to 168 hours
To measure the concentrations of retinol-binding protein 4 (RBP4), a pharmacodynamic (PD) biomarker, in plasma following a single oral dose in healthy volunteers aged 50-85
Level of RBP4 at 24 hours as percent of baseline concentration (C%b24h)
Measured: Up to 168 hours
To measure the concentrations of retinol-binding protein 4 (RBP4), a pharmacodynamic (PD) biomarker, in plasma following a single oral dose in healthy volunteers aged 50-85
Half-life for recovery of RBP4 to baseline levels (PDt1/2)
Measured: Up to 168 hours
Secondary outcomes (16)
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Incidence, type, severity, and relationship of AEs/serious AEs (SAEs), including withdrawals due to AEs;
Measured: Up to 15 days
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Changes from baseline in vital sign measurements (systolic and diastolic blood pressure (BP))
Measured: Up to 15 days
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Changes from baseline in vital sign measurements (heart rate (HR))
Measured: Up to 15 days
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Changes from baseline in vital sign measurements (respiratory rate)
Measured: Up to 15 days
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Changes from baseline in vital sign measurements (body temperature)
Measured: Up to 15 days
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Changes from baseline in electrocardiogram (ECG) parameters (RR interval)
Measured: Up to 15 days
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Changes from baseline in electrocardiogram (ECG) parameters (PR interval)
Measured: Up to 15 days
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Changes from baseline in electrocardiogram (ECG) parameters (QRS width)
Measured: Up to 15 days
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Changes from baseline in electrocardiogram (ECG) parameters (QT interval)
Measured: Up to 15 days
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Changes from baseline in electrocardiogram (ECG) parameters (QTcB)
Measured: Up to 15 days
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Changes from baseline in electrocardiogram (ECG) parameters (QTcF)
Measured: Up to 15 days
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Changes from baseline in visual acuity scores
Measured: Up to 15 days
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Changes from baseline in colour vision scores
Measured: Up to 15 days
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Ocular examination assessments (slit lamp biomicroscopy)
Measured: Up to 15 days
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Ocular examination assessments (dilated ophthalmoscopy)
Measured: Up to 15 days
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Ocular examination assessments (intraocular pressure)
Measured: Up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start28 Nov 2022
- Primary completion4 Jan 2023
- Study completion18 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- RBP4 Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Belite Bio, Inc
- Responsible party
- Sponsor
- Investigators
- Sam Francis, Principal investigator, Nucleus Network - Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667688
- Sponsor's protocol ID
- LBS-008-CT06
- Status last verified
- Feb 2023
- First submitted
- 15 Nov 2022
- Last updated
- 23 Feb 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: After completion of the study, data may be considered for reporting at a scientific meeting or for publication in a scientific journal. In these cases, the sponsor will be responsible for these activities and will work with the investigators to determine how the manuscript is written and edited, the number and order of authors, the publication to which it will be submitted, and any other related issues. The sponsor has final approval authority of all such issues. Data are the property of the sponsor and cannot be published without their prior authorization, but data and any publication thereof will not be unduly withheld.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Open-Label, Parallel Single-Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Tinlarebant in Healthy Volunteers Aged 50-85
- ClinicalTrials.gov ID
- NCT05667688
- Acronym / sponsor ID
- LBS-008-CT06
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- RBP4 Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Belite Bio, Inc
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 4 Jan 2023 (actual)
- Study completion
- 18 Jan 2023 (actual)
- First posted
- 28 Dec 2022 (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 Phase 1b, parallel single-dose study to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of Tinlarebant when administered as an oral dose to elderly healthy volunteers. This study will evaluate 2 dose levels in 2 cohorts comprising up to a total of 16 participants (8 per cohort). Dose levels will be evaluated in parallel.
Detailed description
This is a Phase 1b, parallel single-dose study to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of tinlarebant when administered as an oral dose to healthy volunteers aged 50-85. Tinlarebant (previously called LBS-008) is being developed as an oral treatment to slow or halt the progression of dry age-related macular degeneration (AMD) and juvenile onset macular degeneration, known as Stargardt disease (STGD). Accumulation of lipofuscin bisretinoids in the retina is associated with several retinal degenerative diseases including dry AMD and STGD. A total of up to 16 healthy volunteers aged 50-85 are planned to be enrolled into 2 cohorts (8 participants per cohort). Participants will receive a single oral dose of tinlarebant, either 5 mg (Cohort 1) or 10 mg (Cohort 2). The total maximum study duration for participants in this study is 45 days, inclusive of visit windows. This includes a screening period of up to 27 days (Day -28 to Day -2), confinement to the clinical facility over 2 nights (Day -1 to Day 2) and 5 outpatient visits including the EOS visit or Day 15. Tinlarebant will be administered in tablet form; a single tinlarebant tablet will contain 5 mg of IP. Participants in Cohort 1 will receive 1 tinlarebant tablet (5 mg dose) and participants in Cohort 2 will receive 2 tinlarebant tablets (10 mg dose). Enrolment and dosing of participants in Cohorts 1 and 2 may occur concurrently. Healthy volunteers aged 50-85, will be screened between Day -28 and Day -2, inclusive. Participants will be admitted to the clinical facility on Day -1 with tinlarebant dosing to occur on the following day (Day 1). All participants will be dosed under fasted conditions. Participants will be confined at the clinical facility from Day -1 through to Day 2 with discharge following completion of all PK and PD blood sample collections and other scheduled assessments on Day2. If participants experience any clinically significant (CS) AEs during the confinement period, they may remain in the clinical facility for further observation at the discretion of the Principal Investigator (PI). Blood samples for PK and PD analysis will be collected pre-dose and at timepoints up to 24 hours (Day 2) post-dose during the confinement period. Participants will be required to attend the clinic as outpatients on Days 3, 4, 6 and 8 for further safety assessments, PK and PD blood sampling. Participants will then return to the clinical facility for final safety assessments at an end of study (EOS) vision Day 15.
In the event of early study termination prior to the EOS visit (Day 15), participants will be requested to attend the clinic for an early termination (ET) visit.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: 5 mg, fasted | Active comparator | Drug: Tinlarebant (LBS-008)A single dose (5 mg) of tinlarebant will be administered to each study participant on study Day 1. |
| Cohort 2: 10 mg, fasted | Active comparator | Drug: Tinlarebant (LBS-008)A single dose (10 mg) of tinlarebant will be administered to each study participant on study Day 1. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
- Healthy adult male or female, or adult male or female with a stable chronic disease or condition aged 50-85 years of age, inclusive. Adults with stable chronic disease or condition includes adults with no new diagnosis, hospitalisation or changes in medication in the 3 months prior to first dose of study drug on Day 1. Ongoing concomitant medications associated with the stable disease or condition, including over-the-counter (OTC) medications and herbal/vitamin supplements taken by volunteers, will be recorded and reviewed by the PI (or delegate) to determine whether the volunteer is suitable for inclusion in the study. In conducting this review, the PI (or delegate) must consider Exclusion Criteria 11, 12, 13 and 14.
- The volunteer is considered by the Investigator to be in stable health
Key exclusion criteria (5 listed)
- Presence of CS cardiovascular, pulmonary, hepatic, renal, haematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease, or any other condition that, in the opinion of the Investigator, would jeopardise the safety of the participant or the validity of the study results.
- Had a CS new illness within 1 month prior to the screening visit, with the exception of fully resolved gastrointestinal illness at least 14 days prior to the screening visit, fully resolved minor colds (e.g., only cold and flu-like symptoms) that occurred within 1 month prior to the screening visit, and fully resolved corona virus disease 2019 (COVID-19) infections if resolved at least 14 days prior to the screening visit and 30 days prior to confinement to the clinical facility.
- A history of uncontrolled hypertension, coronary artery disease, or any other significant cardiovascular disease.
- A history of uncontrolled diabetes. Volunteers with fully resolved gestational diabetes will be eligible to participate in the study.
- A history of unexplained loss of consciousness, epilepsy or other seizure disorder, or cerebrovascular disease.
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 |
|---|---|---|
| Tinlarebant (LBS-008)A single dose of Tinlarebant (LBS-008) will be administered to each study participant on study Day 1. | Drug | Cohort 1: 5 mg, fasted, Cohort 2: 10 mg, fasted |
Primary outcome
To measure the pharmacokinetics (PK) of tinlarebant in plasma following a single oral dose in healthy volunteers aged 50-85.
Time frame: Up to 168 hours
Area under the plasma concentration versus time curve from time 0 to the last time point with quantifiable concentration (AUC0-t)
To measure the pharmacokinetics (PK) of tinlarebant in plasma following a single oral dose in healthy volunteers aged 50-85.
Time frame: Up to 168 hours
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity (AUC0-inf)
To measure the pharmacokinetics (PK) of tinlarebant in plasma following a single oral dose in healthy volunteers aged 50-85.
Time frame: Up to 168 hours
Maximum observed plasma concentration (Cmax)
To measure the pharmacokinetics (PK) of tinlarebant in plasma following a single oral dose in healthy volunteers aged 50-85.
Time frame: Up to 168 hours
Time of maximum observed plasma concentration (Tmax)
To measure the pharmacokinetics (PK) of tinlarebant in plasma following a single oral dose in healthy volunteers aged 50-85.
Time frame: Up to 168 hours
Apparent plasma terminal elimination half-life (t1/2)
To measure the pharmacokinetics (PK) of tinlarebant in plasma following a single oral dose in healthy volunteers aged 50-85.
Time frame: Up to 168 hours
Terminal elimination rate constant (λz)
To measure the pharmacokinetics (PK) of tinlarebant in plasma following a single oral dose in healthy volunteers aged 50-85.
Time frame: Up to 168 hours
Apparent total body clearance (CL/F)
To measure the pharmacokinetics (PK) of tinlarebant in plasma following a single oral dose in healthy volunteers aged 50-85.
Time frame: Up to 168 hours
Apparent volume of distribution (Vz/F)
To measure the concentrations of retinol-binding protein 4 (RBP4), a pharmacodynamic (PD) biomarker, in plasma following a single oral dose in healthy volunteers aged 50-85
Time frame: Up to 168 hours
Time of minimal RPB4 levels post-dose (Tmin)
To measure the concentrations of retinol-binding protein 4 (RBP4), a pharmacodynamic (PD) biomarker, in plasma following a single oral dose in healthy volunteers aged 50-85
Time frame: Up to 168 hours
Maximal suppression to RBP4 expressed as minimum concentration of RBP4 (Cmin)
To measure the concentrations of retinol-binding protein 4 (RBP4), a pharmacodynamic (PD) biomarker, in plasma following a single oral dose in healthy volunteers aged 50-85
Time frame: Up to 168 hours
Maximal suppression to RBP4 expressed as percent (%) of baseline concentration of RBP4 (C%bmin)
To measure the concentrations of retinol-binding protein 4 (RBP4), a pharmacodynamic (PD) biomarker, in plasma following a single oral dose in healthy volunteers aged 50-85
Time frame: Up to 168 hours
Level of RBP4 at 12 hours as concentration (C12h)
To measure the concentrations of retinol-binding protein 4 (RBP4), a pharmacodynamic (PD) biomarker, in plasma following a single oral dose in healthy volunteers aged 50-85
Time frame: Up to 168 hours
Level of RBP4 at 12 hours as percent of baseline concentration (C%b12h)
To measure the concentrations of retinol-binding protein 4 (RBP4), a pharmacodynamic (PD) biomarker, in plasma following a single oral dose in healthy volunteers aged 50-85
Time frame: Up to 168 hours
Level of RBP4 at 24 hours as concentration (C24h)
To measure the concentrations of retinol-binding protein 4 (RBP4), a pharmacodynamic (PD) biomarker, in plasma following a single oral dose in healthy volunteers aged 50-85
Time frame: Up to 168 hours
Level of RBP4 at 24 hours as percent of baseline concentration (C%b24h)
To measure the concentrations of retinol-binding protein 4 (RBP4), a pharmacodynamic (PD) biomarker, in plasma following a single oral dose in healthy volunteers aged 50-85
Time frame: Up to 168 hours
Half-life for recovery of RBP4 to baseline levels (PDt1/2)
16 secondary outcomes
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Time frame: Up to 15 days
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Time frame: Up to 15 days
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Time frame: Up to 15 days
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Time frame: Up to 15 days
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Time frame: Up to 15 days
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Time frame: Up to 15 days
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Time frame: Up to 15 days
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Time frame: Up to 15 days
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Time frame: Up to 15 days
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Time frame: Up to 15 days
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Time frame: Up to 15 days
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Time frame: Up to 15 days
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Time frame: Up to 15 days
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Time frame: Up to 15 days
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Time frame: Up to 15 days
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Time frame: Up to 15 days
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 23 Feb 2023.
- Individual participant dataSharing planned: No. After completion of the study, data may be considered for reporting at a scientific meeting or for publication in a scientific journal. In these cases, the sponsor will be responsible for these activities and will work with the investigators to determine how the manuscript is written and edited, the number and order of authors, the publication to which it will be submitted, and any other related issues. The sponsor has final approval authority of all such issues. Data are the property of the sponsor and cannot be published without their prior authorization, but data and any publication thereof will not be unduly withheld.
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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.
Sam Francis principal investigator
Nucleus Network - Melbourne
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 Tinlarebant (LBS-008) in people with Healthy Volunteer and Dry Age-related Macular Degeneration, run by RBP4 Pty Ltd 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 3 inclusion and 5 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 23 Feb 2023. 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 measure the pharmacokinetics (PK) of tinlarebant in plasma following a single oral dose in healthy volunteers aged 50-85. (time frame: Up to 168 hours). The study lists 16 primary outcomes in all. 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 23 Feb 2023.