Healthy SubjectsPhase 1NCT06100627
A Pharmacodynamic Effect Study of AP301 in Healthy Volunteers
A Phase 1 study testing AP301 in people with Healthy Subjects, run by Alebund Pty Ltd at 1 site in Australia.
Trial summary
This is a randomized, open-label, parallel-group, phase 1 study to evaluate the PD effect of AP301 capsule in healthy volunteers. The study is planned to have 4 treatment arms: Arm 1: 2.10 g/day; arm 2: 4.20 g/day; arm 3: 6.30 g/day; arm 4: 8.40 g/day. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- AP301
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteAustralia
- Study dates
- 11 Jan 2024to 28 Feb 2024
- 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
- Men only
- Healthy volunteers accepted
- Adult
Important Inclusion Criteria:
- Healthy male volunteers, 18-55 years of age
- Body mass index (BMI) 18-30 kg/m2 (exclusive) at screening.
Important Exclusion Criteria:
- Serum phosphorus is below 1.00 mmol/L at screening.
- History of significant gastrointestinal disease or disorder, major gastrointestinal surgeries, or cholecystectomy
- History or symptoms of any clinically significant kidney, liver, broncho-pulmonary, gastrointestinal, neurological, psychiatric, cardiovascular, endocrine/metabolic, hematological diseases, or cancer.
- History of specific allergies or allergic conditions or known allergies to the study drug as judged by the investigator, or any confirmed significant allergic reactions (urticaria or anaphylaxis) to any drug, or multiple drug allergies (non-active hay fever is acceptable). Allowing for childhood asthma, history of mild eczema that has had no flare ups for ≥5 years or is fully resolved.
- Known history of allergy to common food like milk or gluten, or lactose intolerance, or special diet habit for religious/life-style reasons, which might potentially jeopardize the participant's compliance of study diet.
- Any clinically significant concomitant disease, or condition or treatment that could interfere with the conduct of the study.
- Confirmed (based on the average of 3 separate resting blood pressure measurements, after at least 5 minutes rest) systolic blood pressure (BP) greater than 150 or less than 90 mmHg, and diastolic BP greater than 90 or less than 50 mmHg at screening.
- Clinically relevant ECG abnormalities on screening ECG.
- Estimated glomerular filtration rate (eGFR) ≤ 70 mL/min/1.73 m2.
- Positive test at screening of any of the following: Hepatitis B (HBsAg), Hepatitis C (HCV Ab) or human immunodeficiency virus (HIV-1 or HIV-2 Ab).
- Alanine aminotransferase (ALT) or aspartate transaminase (AST) > 1.5 × upper limit of normal (ULN), or any other clinically significant abnormalities in laboratory test results at screening.
- Dosed with a small-molecule or biologic investigational drug within 30 days or 90 days, respectively, or 5 half-lives (whichever is the longer) prior to first dose of this study.
- Positive urine test for drugs of abuse and/or positive alcohol test at screening.
- Any medical or social conditions that, in the view of investigator, might potentially jeopardize the participant's compliance of study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Parallel Group, Phase 1 Study to Assess the Pharmacodynamic Effect of AP301 on Urinary Phosphorus Excretion in Healthy Volunteers
This is a randomized, open-label, parallel-group, phase 1 study to evaluate the PD effect of AP301 capsule in healthy volunteers. The study is planned to have 4 treatment arms: Arm 1: 2.10 g/day; arm 2: 4.20 g/day; arm 3: 6.30 g/day; arm 4: 8.40 g/day.
Read the detailed description
A total of 32 participants will participate in this study and the study consists of 3 periods such as screening period, hospitalization period and follow up period.
- Conditions
- Healthy Subjects
- Being tested
- AP301
- Keywords
- Pharmacodynamic, safety, tolerability, AP301, Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AP301Drug
Orally administered
| Study group | Role | What they receive |
|---|---|---|
| 2.10 g/day of AP301 | Experimental | Not described Receives: Drug: AP301 |
| 4.20 g/day of AP301 | Experimental | Not described Receives: Drug: AP301 |
| 6.30 g/day of AP301 | Experimental | Not described Receives: Drug: AP301 |
| 8.40 g.day of AP301 | Experimental | Not described Receives: Drug: AP301 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary phosphorus excretion during AP301 administration
Average daily urinary phosphorus excretion during the 3 consecutive days of AP301 treatment
Measured: From the Day 1 to Day 4 after dosing, assessed up to 3 days
Effect of AP301 on urinary phosphorus excretion
Change of average daily urinary phosphorus excretion from 3 days before treatment to 3 days during treatment.
Measured: From Day -3 to Day 4 after dosing, assessed up to 6 days
Urinary calcium excretion during AP301 administration
Average daily urinary calcium excretion during the 3 consecutive days of AP301 treatment.
Measured: From the Day 1 to Day 4 after dosing, assessed up to 3 days
Effect of AP301 on urinary calcium excretion
Change of average daily urinary calcium excretion from 3 days before treatment to 3 days during treatment.
Measured: From Day -3 to Day 4 after dosing, assessed up to 6 days
Effect of AP301 on serum phosphorus and calcium
Changes of serum phosphorus and serum calcium from baseline to end of treatment.
Measured: From Day -3 to Day 4 after dosing, assessed up to 6 days
Secondary outcomes (5)
Incidence and severity of adverse events (AEs)
Number of participants with adverse events (AEs) and the intensity of adverse events.
Number of participants with serious adverse events (SAEs) and the intensity of adverse events.
Measured: From screening to hospitalization and follow up periods, assessed up to 43 days
Changes in clinical laboratory values
Changes and their clinical meaningfulness in clinical laboratory values: Hematology, Biochemistry, Urinalysis
Measured: From screening to hospitalization and follow up periods, assessed up to 43 days
Abnormal electrocardiogram (ECG) readings and their clinical meaningfulness
ECG intervals (PR [PQ], QRS, QT, QTcF) and heart rate
Measured: From screening to hospitalization and follow up periods, assessed up to 43 days
Changes of ECG parameters and their clinical meaningfulness
ECG intervals (PR [PQ], QRS, QT, QTcF), heart rate, T-wave morphology and U-wave morphology.
Measured: From screening to hospitalization and follow up periods, assessed up to 43 days
Abnormal vital signs and their clinical meaningfulness
Blood pressure, heart rate and body temperature
Measured: From screening to hospitalization and follow up periods, assessed up to 43 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start11 Jan 2024
- Primary completion8 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alebund Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sam Francis, Doctor, Principal investigator, Nucleus Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100627
- Sponsor's protocol ID
- AP301-PD-01
- Status last verified
- May 2024
- First submitted
- 17 Oct 2023
- Last updated
- 10 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Parallel Group, Phase 1 Study to Assess the Pharmacodynamic Effect of AP301 on Urinary Phosphorus Excretion in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06100627
- Acronym / sponsor ID
- AP301-PD-01
- Conditions
- Healthy Subjects
- Keywords
- Pharmacodynamic, safety, tolerability, AP301, Healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Alebund Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- 8 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 25 Oct 2023 (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 randomized, open-label, parallel-group, phase 1 study to evaluate the PD effect of AP301 capsule in healthy volunteers. The study is planned to have 4 treatment arms: Arm 1: 2.10 g/day; arm 2: 4.20 g/day; arm 3: 6.30 g/day; arm 4: 8.40 g/day.
Detailed description
A total of 32 participants will participate in this study and the study consists of 3 periods such as screening period, hospitalization period and follow up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2.10 g/day of AP301 | Experimental | Drug: AP301 |
| 4.20 g/day of AP301 | Experimental | Drug: AP301 |
| 6.30 g/day of AP301 | Experimental | Drug: AP301 |
| 8.40 g.day of AP301 | Experimental | Drug: AP301 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| AP301Orally administered | Drug | 2.10 g/day of AP301, 4.20 g/day of AP301, 6.30 g/day of AP301, 8.40 g.day of AP301 |
Primary outcome
Urinary phosphorus excretion during AP301 administration
Time frame: From the Day 1 to Day 4 after dosing, assessed up to 3 days
Average daily urinary phosphorus excretion during the 3 consecutive days of AP301 treatment
Effect of AP301 on urinary phosphorus excretion
Time frame: From Day -3 to Day 4 after dosing, assessed up to 6 days
Change of average daily urinary phosphorus excretion from 3 days before treatment to 3 days during treatment.
Urinary calcium excretion during AP301 administration
Time frame: From the Day 1 to Day 4 after dosing, assessed up to 3 days
Average daily urinary calcium excretion during the 3 consecutive days of AP301 treatment.
Effect of AP301 on urinary calcium excretion
Time frame: From Day -3 to Day 4 after dosing, assessed up to 6 days
Change of average daily urinary calcium excretion from 3 days before treatment to 3 days during treatment.
Effect of AP301 on serum phosphorus and calcium
Time frame: From Day -3 to Day 4 after dosing, assessed up to 6 days
Changes of serum phosphorus and serum calcium from baseline to end of treatment.
5 secondary outcomes
Incidence and severity of adverse events (AEs)
Time frame: From screening to hospitalization and follow up periods, assessed up to 43 days
Changes in clinical laboratory values
Time frame: From screening to hospitalization and follow up periods, assessed up to 43 days
Abnormal electrocardiogram (ECG) readings and their clinical meaningfulness
Time frame: From screening to hospitalization and follow up periods, assessed up to 43 days
Changes of ECG parameters and their clinical meaningfulness
Time frame: From screening to hospitalization and follow up periods, assessed up to 43 days
Abnormal vital signs and their clinical meaningfulness
Time frame: From screening to hospitalization and follow up periods, assessed up to 43 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 10 May 2024.
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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, Doctor principal investigator
Nucleus Network
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 AP301 in people with Healthy Subjects, run by Alebund 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?
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 10 May 2024. 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?
Urinary phosphorus excretion during AP301 administration (time frame: From the Day 1 to Day 4 after dosing, assessed up to 3 days). The study lists 5 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 10 May 2024.