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

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05503693
• Other study ID #: AP303-PK-01
• Status: Completed
• Phase: Phase 1
• Start date: December 6, 2022
• Est. completion date: July 21, 2023

Study information

• Verified date: May 2024
• Source: Alebund Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: July 21, 2023
• Est. primary completion date: July 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• AP303 50 µg
AP303 tablet
• AP303 150 µg
AP303 tablet
• AP303 300 µg
AP303 tablet
• AP303 600 µg
AP303 tablet
• Placebo 50 µg
Placebo tablet
• Placebo 150 µg
Placebo tablet
• Placebo 300 µg
Placebo tablet
• Placebo 600 µg
Placebo tablet

Locations

Country	Name	City	State
Australia	Nucleus Network Pty Ltd	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Alebund Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Single Dose and Food Effect Safety Outcome Measures	Incidence and severity of adverse events (AEs), laboratory, ECG, and vital sign changes	From baseline to Day 14 (Day 29 for Food Effect)
Primary	Multiple Dose Safety Outcome Measures	Incidence and severity of AEs, laboratory, ECG, and vital sign changes.	From baseline to Day 28
Primary	Cmax after single dose	PK characteristics after single dose	Pre-dose to 96 hours post-dose
Primary	Tmax after single dose	PK characteristics after single dose	Pre-dose to 96 hours post-dose
Primary	AUC0-last after single dose	PK characteristics after single dose	Pre-dose to 96 hours post-dose
Primary	AUC0-inf after single dose	PK characteristics after single dose	Pre-dose to 96 hours post-dose
Primary	t1/2 after single dose	PK characteristics after single dose	Pre-dose to 96 hours post-dose
Primary	CL/F after single dose	PK characteristics after single dose	Pre-dose to 96 hours post-dose
Primary	Ae and CLR (if warranted) after single dose	PK characteristics after single dose	Pre-dose to 96 hours post-dose
Primary	V/F after single dose	PK characteristics after single dose	Pre-dose to 96 hours post-dose
Primary	Cmax after multiple dose	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
Primary	Tmax after multiple dose	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
Primary	AUC0-t after multiple dose	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
Primary	Cav after multiple dose	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
Primary	t1/2 after multiple dose	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
Primary	Rac after multiple dose	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
Primary	Ae and CLR (if warranted) after multiple dose	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
Primary	V/F after multiple dose	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
Primary	Ctrough after multiple dose	PK characteristics after multiple dose	Pre-dose on Days 2, 3, 4, 5, 7, 12, and 13
Secondary	Effect of Food on the single dose Cmax	Effect of food on the single dose PK	Pre-dose to 96 hours post-dose
Secondary	Effect of Food on the single dose Tmax	Effect of food on the single dose PK	Pre-dose to 96 hours post-dose
Secondary	Effect of Food on the single dose AUC0-last	Effect of food on the single dose PK	Pre-dose to 96 hours post-dose
Secondary	Effect of Food on the single dose AUC0-inf	Effect of food on the single dose PK	Pre-dose to 96 hours post-dose
Secondary	Effect of Food on the single dose t1/2	Effect of food on the single dose PK	Pre-dose to 96 hours post-dose
Secondary	Effect of Food on the single dose CL/F	Effect of food on the single dose PK	Pre-dose to 96 hours post-dose
Secondary	Effect of Food on the single dose Ae and CLR (if warranted)	Effect of food on the single dose PK	Pre-dose to 96 hours post-dose
Secondary	Effect of Food on the single dose V/F	Effect of food on the single dose PK	Pre-dose to 96 hours post-dose