Clinical trial NCT05503693: A Safety, Tolerability, and Pharmacokinetics Study of AP303 in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: Safety, Tolerability, Pharmacokinetics, AP303, Healthy Subjects
Lead sponsor: Alebund Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-08-17
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Single Dose and Food Effect Safety Outcome Measures
timeFrame: From baseline to Day 14 (Day 29 for Food Effect)
measure: Multiple Dose Safety Outcome Measures
timeFrame: From baseline to Day 28
measure: Cmax after single dose
timeFrame: Pre-dose to 96 hours post-dose
measure: Tmax after single dose
timeFrame: Pre-dose to 96 hours post-dose
measure: AUC0-last after single dose
timeFrame: Pre-dose to 96 hours post-dose
measure: AUC0-inf after single dose
timeFrame: Pre-dose to 96 hours post-dose
measure: t1/2 after single dose
timeFrame: Pre-dose to 96 hours post-dose
measure: CL/F after single dose
timeFrame: Pre-dose to 96 hours post-dose
measure: Ae and CLR (if warranted) after single dose
timeFrame: Pre-dose to 96 hours post-dose
measure: V/F after single dose
timeFrame: Pre-dose to 96 hours post-dose
measure: Cmax after multiple dose
timeFrame: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
measure: Tmax after multiple dose
timeFrame: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
measure: AUC0-τ after multiple dose
timeFrame: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
measure: Cav after multiple dose
timeFrame: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
measure: t1/2 after multiple dose
timeFrame: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
measure: Rac after multiple dose
timeFrame: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
measure: Ae and CLR (if warranted) after multiple dose
timeFrame: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
measure: V/F after multiple dose
timeFrame: Pre-dose to 12 hours post dose on Day 1; pre-dose to 96 hours post-dose on Day 14
measure: Ctrough after multiple dose
timeFrame: Pre-dose on Days 2, 3, 4, 5, 7, 12, and 13
Secondary outcomes:
measure: Effect of Food on the single dose Cmax
timeFrame: Pre-dose to 96 hours post-dose
measure: Effect of Food on the single dose Tmax
timeFrame: Pre-dose to 96 hours post-dose
measure: Effect of Food on the single dose AUC0-last
timeFrame: Pre-dose to 96 hours post-dose
measure: Effect of Food on the single dose AUC0-inf
timeFrame: Pre-dose to 96 hours post-dose
measure: Effect of Food on the single dose t1/2
timeFrame: Pre-dose to 96 hours post-dose
measure: Effect of Food on the single dose CL/F
timeFrame: Pre-dose to 96 hours post-dose
measure: Effect of Food on the single dose Ae and CLR (if warranted)
timeFrame: Pre-dose to 96 hours post-dose
measure: Effect of Food on the single dose V/F
timeFrame: Pre-dose to 96 hours post-dose
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network Pty Ltd
state: Victoria
Study officials:
affiliation: Nucleus Network
name: Sam Francis, Doctor
role: PRINCIPAL_INVESTIGATOR
References: