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

NCT05503693 | Completed Phase 1 DMC

• 1 other identifier: AP303-PK-01
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Keywords

Safety, Tolerability, Pharmacokinetics, AP303, Healthy Subjects

Outcome Measures

Primary Outcomes (19)

• 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)

• Multiple Dose Safety Outcome Measures

  Incidence and severity of AEs, laboratory, ECG, and vital sign changes.

  From baseline to Day 28

• Cmax after single dose

  PK characteristics after single dose

  Pre-dose to 96 hours post-dose

• Tmax after single dose

  PK characteristics after single dose

  Pre-dose to 96 hours post-dose

• AUC0-last after single dose

  PK characteristics after single dose

  Pre-dose to 96 hours post-dose

• AUC0-inf after single dose

  PK characteristics after single dose

  Pre-dose to 96 hours post-dose

• t1/2 after single dose

  PK characteristics after single dose

  Pre-dose to 96 hours post-dose

• CL/F after single dose

  PK characteristics after single dose

  Pre-dose to 96 hours post-dose

• Ae and CLR (if warranted) after single dose

  PK characteristics after single dose

  Pre-dose to 96 hours post-dose

• V/F after single dose

  PK characteristics after single dose

  Pre-dose to 96 hours post-dose

• 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

• 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

• AUC0-τ 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

• 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

• 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

• 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

• 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

• 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

• Ctrough after multiple dose

  PK characteristics after multiple dose

  Pre-dose on Days 2, 3, 4, 5, 7, 12, and 13

Secondary Outcomes (8)

• Effect of Food on the single dose Cmax

  Pre-dose to 96 hours post-dose

• Effect of Food on the single dose Tmax

  Pre-dose to 96 hours post-dose

• Effect of Food on the single dose AUC0-last

  Pre-dose to 96 hours post-dose

• Effect of Food on the single dose AUC0-inf

  Pre-dose to 96 hours post-dose

• Effect of Food on the single dose t1/2

  Pre-dose to 96 hours post-dose

Study Arms (2)

AP303

EXPERIMENTAL

AP303

Drug: AP303 50 μg; Drug: AP303 150 μg; Drug: AP303 300 μg; Drug: AP303 600 μg

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo 50 μg; Drug: Placebo 150 μg; Drug: Placebo 300 μg; Drug: Placebo 600 μg

Interventions

AP303 50 μg DRUG

AP303 tablet

AP303

AP303 150 μg DRUG

AP303 tablet

AP303

AP303 300 μg DRUG

AP303 tablet

AP303

AP303 600 μg DRUG

AP303 tablet

AP303

Placebo 50 μg DRUG

Placebo tablet

Placebo

Placebo 150 μg DRUG

Placebo tablet

Placebo

Placebo 300 μg DRUG

Placebo tablet

Placebo

Placebo 600 μg DRUG

Placebo tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alebund Pty Ltd: lead

Study Sites (1)

Nucleus Network Pty Ltd

Melbourne, Victoria, 3004, Australia

Location

Study Officials

• Sam Francis, Doctor

  Nucleus Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 17, 2022
• Study Start: December 6, 2022
• Primary Completion: July 21, 2023
• Study Completion: July 21, 2023
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

AU (1)