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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05503693




Registration number
NCT05503693
Ethics application status
Date submitted
15/08/2022
Date registered
17/08/2022
Date last updated
30/05/2024

Titles & IDs
Public title
A Safety, Tolerability, and Pharmacokinetics Study of AP303 in Healthy Subjects
Scientific 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
Secondary ID [1] 0 0
AP303-PK-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Subjects 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AP303 50 µg
Treatment: Drugs - AP303 150 µg
Treatment: Drugs - AP303 300 µg
Treatment: Drugs - AP303 600 µg
Treatment: Drugs - Placebo 50 µg
Treatment: Drugs - Placebo 150 µg
Treatment: Drugs - Placebo 300 µg
Treatment: Drugs - Placebo 600 µg

Experimental: AP303 - AP303

Placebo Comparator: Placebo - Placebo


Treatment: Drugs: AP303 50 µg
AP303 tablet

Treatment: Drugs: AP303 150 µg
AP303 tablet

Treatment: Drugs: AP303 300 µg
AP303 tablet

Treatment: Drugs: AP303 600 µg
AP303 tablet

Treatment: Drugs: Placebo 50 µg
Placebo tablet

Treatment: Drugs: Placebo 150 µg
Placebo tablet

Treatment: Drugs: Placebo 300 µg
Placebo tablet

Treatment: Drugs: Placebo 600 µg
Placebo tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Single Dose and Food Effect Safety Outcome Measures
Timepoint [1] 0 0
From baseline to Day 14 (Day 29 for Food Effect)
Primary outcome [2] 0 0
Multiple Dose Safety Outcome Measures
Timepoint [2] 0 0
From baseline to Day 28
Primary outcome [3] 0 0
Cmax after single dose
Timepoint [3] 0 0
Pre-dose to 96 hours post-dose
Primary outcome [4] 0 0
Tmax after single dose
Timepoint [4] 0 0
Pre-dose to 96 hours post-dose
Primary outcome [5] 0 0
AUC0-last after single dose
Timepoint [5] 0 0
Pre-dose to 96 hours post-dose
Primary outcome [6] 0 0
AUC0-inf after single dose
Timepoint [6] 0 0
Pre-dose to 96 hours post-dose
Primary outcome [7] 0 0
t1/2 after single dose
Timepoint [7] 0 0
Pre-dose to 96 hours post-dose
Primary outcome [8] 0 0
CL/F after single dose
Timepoint [8] 0 0
Pre-dose to 96 hours post-dose
Primary outcome [9] 0 0
Ae and CLR (if warranted) after single dose
Timepoint [9] 0 0
Pre-dose to 96 hours post-dose
Primary outcome [10] 0 0
V/F after single dose
Timepoint [10] 0 0
Pre-dose to 96 hours post-dose
Primary outcome [11] 0 0
Cmax after multiple dose
Timepoint [11] 0 0
Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
Primary outcome [12] 0 0
Tmax after multiple dose
Timepoint [12] 0 0
Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
Primary outcome [13] 0 0
AUC0-t after multiple dose
Timepoint [13] 0 0
Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
Primary outcome [14] 0 0
Cav after multiple dose
Timepoint [14] 0 0
Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
Primary outcome [15] 0 0
t1/2 after multiple dose
Timepoint [15] 0 0
Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
Primary outcome [16] 0 0
Rac after multiple dose
Timepoint [16] 0 0
Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
Primary outcome [17] 0 0
Ae and CLR (if warranted) after multiple dose
Timepoint [17] 0 0
Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
Primary outcome [18] 0 0
V/F after multiple dose
Timepoint [18] 0 0
Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
Primary outcome [19] 0 0
Ctrough after multiple dose
Timepoint [19] 0 0
Pre-dose on Days 2, 3, 4, 5, 7, 12, and 13
Secondary outcome [1] 0 0
Effect of Food on the single dose Cmax
Timepoint [1] 0 0
Pre-dose to 96 hours post-dose
Secondary outcome [2] 0 0
Effect of Food on the single dose Tmax
Timepoint [2] 0 0
Pre-dose to 96 hours post-dose
Secondary outcome [3] 0 0
Effect of Food on the single dose AUC0-last
Timepoint [3] 0 0
Pre-dose to 96 hours post-dose
Secondary outcome [4] 0 0
Effect of Food on the single dose AUC0-inf
Timepoint [4] 0 0
Pre-dose to 96 hours post-dose
Secondary outcome [5] 0 0
Effect of Food on the single dose t1/2
Timepoint [5] 0 0
Pre-dose to 96 hours post-dose
Secondary outcome [6] 0 0
Effect of Food on the single dose CL/F
Timepoint [6] 0 0
Pre-dose to 96 hours post-dose
Secondary outcome [7] 0 0
Effect of Food on the single dose Ae and CLR (if warranted)
Timepoint [7] 0 0
Pre-dose to 96 hours post-dose
Secondary outcome [8] 0 0
Effect of Food on the single dose V/F
Timepoint [8] 0 0
Pre-dose to 96 hours post-dose

Eligibility
Key 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/07/2023
Sample size
Target
Accrual to date
Final
62
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Alebund Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05503693
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sam Francis, Doctor
Address 0 0
Nucleus Network
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries