A Safety, Tolerability, and Pharmacokinetics Study of AP303 in Healthy Subjects

May 29, 2024 updated by: Alebund Pty Ltd

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Nucleus Network Pty Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Healthy male and female subjects, 18 to 55 years of age, inclusive.
  2. Body Mas index(BMI) between 18 to 32 kg/m2 inclusive.
  3. 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
  4. 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

Exclusion Criteria:

  1. Pregnant (positive pregnancy test) or lactating women, and male subjects with partners who are or plan to be pregnant or lactating.
  2. 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.
  3. People with a history of specific allergies, or allergic conditions or known allergies to any ingredient of the investigational medicinal product (IMP).
  4. 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.
  5. Positive test at screening of any of the following: Hepatitis B (HBsAg), Hepatitis C (HCVAb) or human immunodeficiency virus (HIV Ab).
  6. 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.
  7. History of drug and/or alcohol abuse or addiction.
  8. Use of >5 cigarettes or equivalent nicotine-containing product per day.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo 50 μg
Placebo tablet
Drug: Placebo 150 μg
Placebo tablet
Drug: Placebo 300 μg
Placebo tablet
Drug: Placebo 600 μg
Placebo tablet
Experimental: AP303
Drug: AP303 50 μg
AP303 tablet
Drug: AP303 150 μg
AP303 tablet
Drug: AP303 300 μg
AP303 tablet
Drug: AP303 600 μg
AP303 tablet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From baseline to Day 14 (Day 29 for Food Effect)
Multiple Dose Safety Outcome Measures
Time Frame: From baseline to Day 28
Incidence and severity of AEs, laboratory, ECG, and vital sign changes.
From baseline to Day 28
Cmax after single dose
Time Frame: Pre-dose to 96 hours post-dose
PK characteristics after single dose
Pre-dose to 96 hours post-dose
Tmax after single dose
Time Frame: Pre-dose to 96 hours post-dose
PK characteristics after single dose
Pre-dose to 96 hours post-dose
AUC0-last after single dose
Time Frame: Pre-dose to 96 hours post-dose
PK characteristics after single dose
Pre-dose to 96 hours post-dose
AUC0-inf after single dose
Time Frame: Pre-dose to 96 hours post-dose
PK characteristics after single dose
Pre-dose to 96 hours post-dose
t1/2 after single dose
Time Frame: Pre-dose to 96 hours post-dose
PK characteristics after single dose
Pre-dose to 96 hours post-dose
CL/F after single dose
Time Frame: Pre-dose to 96 hours post-dose
PK characteristics after single dose
Pre-dose to 96 hours post-dose
Ae and CLR (if warranted) after single dose
Time Frame: Pre-dose to 96 hours post-dose
PK characteristics after single dose
Pre-dose to 96 hours post-dose
V/F after single dose
Time Frame: Pre-dose to 96 hours post-dose
PK characteristics after single dose
Pre-dose to 96 hours post-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
Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
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
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
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
Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
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
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
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
Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
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
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
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
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
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
Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
Ctrough after multiple dose
Time Frame: Pre-dose on Days 2, 3, 4, 5, 7, 12, and 13
PK characteristics after multiple dose
Pre-dose on Days 2, 3, 4, 5, 7, 12, and 13

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effect of Food on the single dose Cmax
Time Frame: Pre-dose to 96 hours post-dose
Effect of food on the single dose PK
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 PK
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 PK
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 PK
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 PK
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 PK
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 PK
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
Effect of food on the single dose PK
Pre-dose to 96 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alebund Pty Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sam Francis, Doctor, Nucleus Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 6, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 21, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 21, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AP303-PK-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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