Healthy SubjectsPhase 1NCT05503693
A Safety, Tolerability, and Pharmacokinetics Study of AP303 in Healthy Subjects
A Phase 1 study testing AP303 50 μg, AP303 150 μg and AP303 300 μg in people with Healthy Subjects, run by Alebund Pty Ltd at 1 site in Australia.
Trial summary
This is a single-center, randomized, double-blind, placebo-controlled, first-in-human study in which the safety, tolerability, and pharmacokinetics of orally administered AP303 will be assessed in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- AP303 50 μg, AP303 150 μg and AP303 300 μg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteAustralia
- Study dates
- 6 Dec 2022to 21 Jul 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects, 18 to 55 years of age, inclusive.
- Body Mas index(BMI) between 18 to 32 kg/m2 inclusive.
- Female subjects of child-bearing potential must have a negative pregnancy test result and agree to use highly effective contraception consisting of two forms of birth control
- Subjects and their partners of childbearing potential must use two medically approved methods of contraception and the subjects should refrain from sperm/egg donation for the duration of the study and for 3 months after drug administration
Who cannot join
- Pregnant (positive pregnancy test) or lactating women, and male subjects with partners who are or plan to be pregnant or lactating.
- History or symptoms of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, ophthalmologic, hematological or allergic disease, metabolic disorder, cancer or cirrhosis.
- People with a history of specific allergies, or allergic conditions or known allergies to any ingredient of the investigational medicinal product (IMP).
- History of having received or currently receiving any systemic anti-neoplastic or immune-modulatory treatment ≤ 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study.
- Positive test at screening of any of the following: Hepatitis B (HBsAg), Hepatitis C (HCVAb) or human immunodeficiency virus (HIV Ab).
- Received an investigational drug within 30 days or 5 xT1/2 whichever is longer prior to the first dose of our study for small molecule; or within 90 days or 5 x T1/2 whichever is longer prior to the first dose of our study drug; or device study within 90 days prior to screening or more than 4 times per year.
- History of drug and/or alcohol abuse or addiction.
- Use of >5 cigarettes or equivalent nicotine-containing product per day.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center Randomized Double-blind Placebo-controlled Study to Investigate the Safety Tolerability and PK of SAD and MAD of AP303 Following Oral Administration and the Effect of Food on the PK of AP303 in Healthy Subjects
This is a single-center, randomized, double-blind, placebo-controlled, first-in-human study in which the safety, tolerability, and pharmacokinetics of orally administered AP303 will be assessed in healthy adult subjects.
Read the detailed description
The study will consist of 2 parts: Part A is a single ascending doses (SAD) phase enrolling a total of 4 cohorts of healthy subjects; Part B is a multiple ascending doses (MAD) phase enrolling 3 cohorts of healthy subjects. One cohort of Part A will receive AP303 under both fasted and fed conditions to investigate the effect of food.
- Conditions
- Healthy Subjects
- Being tested
- AP303 50 μg, AP303 150 μg, AP303 300 μg, AP303 600 μg, Placebo 50 μg
- Keywords
- Safety, Tolerability, Pharmacokinetics, AP303, Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AP303 50 μgDrug
AP303 tablet
AP303 150 μgDrug
AP303 tablet
AP303 300 μgDrug
AP303 tablet
AP303 600 μgDrug
AP303 tablet
Placebo 50 μgDrug
Placebo tablet
Placebo 150 μgDrug
Placebo tablet
Placebo 300 μgDrug
Placebo tablet
Placebo 600 μgDrug
Placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| AP303 | Experimental | AP303 Receives: Drug: AP303 50 μg; Drug: AP303 150 μg; Drug: AP303 300 μg; Drug: AP303 600 μg |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo 50 μg; Drug: Placebo 150 μg; Drug: Placebo 300 μg; Drug: Placebo 600 μg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single Dose and Food Effect Safety Outcome Measures
Incidence and severity of adverse events (AEs), laboratory, ECG, and vital sign changes
Measured: From baseline to Day 14 (Day 29 for Food Effect)
Multiple Dose Safety Outcome Measures
Incidence and severity of AEs, laboratory, ECG, and vital sign changes.
Measured: From baseline to Day 28
Cmax after single dose
PK characteristics after single dose
Measured: Pre-dose to 96 hours post-dose
Tmax after single dose
PK characteristics after single dose
Measured: Pre-dose to 96 hours post-dose
AUC0-last after single dose
PK characteristics after single dose
Measured: Pre-dose to 96 hours post-dose
AUC0-inf after single dose
PK characteristics after single dose
Measured: Pre-dose to 96 hours post-dose
t1/2 after single dose
PK characteristics after single dose
Measured: Pre-dose to 96 hours post-dose
CL/F after single dose
PK characteristics after single dose
Measured: Pre-dose to 96 hours post-dose
Ae and CLR (if warranted) after single dose
PK characteristics after single dose
Measured: Pre-dose to 96 hours post-dose
V/F after single dose
PK characteristics after single dose
Measured: Pre-dose to 96 hours post-dose
Cmax after multiple dose
PK characteristics after multiple dose
Measured: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
Tmax after multiple dose
PK characteristics after multiple dose
Measured: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
AUC0-τ after multiple dose
PK characteristics after multiple dose
Measured: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
Cav after multiple dose
PK characteristics after multiple dose
Measured: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
t1/2 after multiple dose
PK characteristics after multiple dose
Measured: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
Rac after multiple dose
PK characteristics after multiple dose
Measured: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
Ae and CLR (if warranted) after multiple dose
PK characteristics after multiple dose
Measured: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
V/F after multiple dose
PK characteristics after multiple dose
Measured: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
Ctrough after multiple dose
PK characteristics after multiple dose
Measured: Pre-dose on Days 2, 3, 4, 5, 7, 12, and 13
Secondary outcomes (8)
Effect of Food on the single dose Cmax
Effect of food on the single dose PK
Measured: Pre-dose to 96 hours post-dose
Effect of Food on the single dose Tmax
Effect of food on the single dose PK
Measured: Pre-dose to 96 hours post-dose
Effect of Food on the single dose AUC0-last
Effect of food on the single dose PK
Measured: Pre-dose to 96 hours post-dose
Effect of Food on the single dose AUC0-inf
Effect of food on the single dose PK
Measured: Pre-dose to 96 hours post-dose
Effect of Food on the single dose t1/2
Effect of food on the single dose PK
Measured: Pre-dose to 96 hours post-dose
Effect of Food on the single dose CL/F
Effect of food on the single dose PK
Measured: Pre-dose to 96 hours post-dose
Effect of Food on the single dose Ae and CLR (if warranted)
Effect of food on the single dose PK
Measured: Pre-dose to 96 hours post-dose
Effect of Food on the single dose V/F
Effect of food on the single dose PK
Measured: Pre-dose to 96 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start6 Dec 2022
- Primary completion21 Jul 2023
- Study completion21 Jul 2023
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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 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
- NCT05503693
- Sponsor's protocol ID
- AP303-PK-01
- Status last verified
- May 2024
- First submitted
- 15 Aug 2022
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Randomized Double-blind Placebo-controlled Study to Investigate the Safety Tolerability and PK of SAD and MAD of AP303 Following Oral Administration and the Effect of Food on the PK of AP303 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05503693
- Acronym / sponsor ID
- AP303-PK-01
- Conditions
- Healthy Subjects
- Keywords
- Safety, Tolerability, Pharmacokinetics, AP303, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Alebund Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- 21 Jul 2023 (actual)
- Study completion
- 21 Jul 2023 (actual)
- First posted
- 17 Aug 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 single-center, randomized, double-blind, placebo-controlled, first-in-human study in which the safety, tolerability, and pharmacokinetics of orally administered AP303 will be assessed in healthy adult subjects.
Detailed description
The study will consist of 2 parts: Part A is a single ascending doses (SAD) phase enrolling a total of 4 cohorts of healthy subjects; Part B is a multiple ascending doses (MAD) phase enrolling 3 cohorts of healthy subjects. One cohort of Part A will receive AP303 under both fasted and fed conditions to investigate the effect of food.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AP303 | Experimental | Drug: AP303 50 μg, Drug: AP303 150 μg, Drug: AP303 300 μg, Drug: AP303 600 μgAP303 |
| Placebo | Placebo comparator | Drug: Placebo 50 μg, Drug: Placebo 150 μg, Drug: Placebo 300 μg, Drug: Placebo 600 μgPlacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and female subjects, 18 to 55 years of age, inclusive.
- Body Mas index(BMI) between 18 to 32 kg/m2 inclusive.
- Female subjects of child-bearing potential must have a negative pregnancy test result and agree to use highly effective contraception consisting of two forms of birth control
- Subjects and their partners of childbearing potential must use two medically approved methods of contraception and the subjects should refrain from sperm/egg donation for the duration of the study and for 3 months after drug administration
Key exclusion criteria (8 listed)
- Pregnant (positive pregnancy test) or lactating women, and male subjects with partners who are or plan to be pregnant or lactating.
- History or symptoms of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, ophthalmologic, hematological or allergic disease, metabolic disorder, cancer or cirrhosis.
- People with a history of specific allergies, or allergic conditions or known allergies to any ingredient of the investigational medicinal product (IMP).
- History of having received or currently receiving any systemic anti-neoplastic or immune-modulatory treatment ≤ 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study.
- Positive test at screening of any of the following: Hepatitis B (HBsAg), Hepatitis C (HCVAb) or human immunodeficiency virus (HIV Ab).
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 |
|---|---|---|
| AP303 50 μgAP303 tablet | Drug | AP303 |
| AP303 150 μgAP303 tablet | Drug | AP303 |
| AP303 300 μgAP303 tablet | Drug | AP303 |
| AP303 600 μgAP303 tablet | Drug | AP303 |
| Placebo 50 μgPlacebo tablet | Drug | Placebo |
| Placebo 150 μgPlacebo tablet | Drug | Placebo |
| Placebo 300 μgPlacebo tablet | Drug | Placebo |
| Placebo 600 μgPlacebo tablet | Drug | Placebo |
Primary outcome
Single Dose and Food Effect Safety Outcome Measures
Time frame: From baseline to Day 14 (Day 29 for Food Effect)
Incidence and severity of adverse events (AEs), laboratory, ECG, and vital sign changes
Multiple Dose Safety Outcome Measures
Time frame: From baseline to Day 28
Incidence and severity of AEs, laboratory, ECG, and vital sign changes.
Cmax after single dose
Time frame: Pre-dose to 96 hours post-dose
PK characteristics after single dose
Tmax after single dose
Time frame: Pre-dose to 96 hours post-dose
PK characteristics after single dose
AUC0-last after single dose
Time frame: Pre-dose to 96 hours post-dose
PK characteristics after single dose
AUC0-inf after single dose
Time frame: Pre-dose to 96 hours post-dose
PK characteristics after single dose
t1/2 after single dose
Time frame: Pre-dose to 96 hours post-dose
PK characteristics after single dose
CL/F after single dose
Time frame: Pre-dose to 96 hours post-dose
PK characteristics after single dose
Ae and CLR (if warranted) after single dose
Time frame: Pre-dose to 96 hours post-dose
PK characteristics after single dose
V/F after single dose
Time frame: Pre-dose to 96 hours post-dose
PK characteristics after single dose
Cmax after multiple dose
Time frame: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
PK characteristics after multiple dose
Tmax after multiple dose
Time frame: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
PK characteristics after multiple dose
AUC0-τ after multiple dose
Time frame: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
PK characteristics after multiple dose
Cav after multiple dose
Time frame: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
PK characteristics after multiple dose
t1/2 after multiple dose
Time frame: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
PK characteristics after multiple dose
Rac after multiple dose
Time frame: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
PK characteristics after multiple dose
Ae and CLR (if warranted) after multiple dose
Time frame: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
PK characteristics after multiple dose
V/F after multiple dose
Time frame: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
PK characteristics after multiple dose
Ctrough after multiple dose
Time frame: Pre-dose on Days 2, 3, 4, 5, 7, 12, and 13
PK characteristics after multiple dose
8 secondary outcomes
Effect of Food on the single dose Cmax
Time frame: Pre-dose to 96 hours post-dose
Effect of Food on the single dose Tmax
Time frame: Pre-dose to 96 hours post-dose
Effect of Food on the single dose AUC0-last
Time frame: Pre-dose to 96 hours post-dose
Effect of Food on the single dose AUC0-inf
Time frame: Pre-dose to 96 hours post-dose
Effect of Food on the single dose t1/2
Time frame: Pre-dose to 96 hours post-dose
Effect of Food on the single dose CL/F
Time frame: Pre-dose to 96 hours post-dose
Effect of Food on the single dose Ae and CLR (if warranted)
Time frame: Pre-dose to 96 hours post-dose
Effect of Food on the single dose V/F
Time frame: Pre-dose to 96 hours post-dose
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 30 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 AP303 50 μg, AP303 150 μg and AP303 300 μg 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?
The sponsor lists 4 inclusion and 8 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 30 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. Some participants in this study may receive a placebo. 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?
Single Dose and Food Effect Safety Outcome Measures (time frame: From baseline to Day 14 (Day 29 for Food Effect)). The study lists 19 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 30 May 2024.