SAD Study of APR002 Investigating the Safety/Tolerability, Pharmacokinetics/Pharmacodynamics in Healthy Subjects

Early Phase 1CompletedNCT05268198

Global Health Drug Discovery Institute42 enrolled

Overview

This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of APR002 in healthy subjects.

A Phase 1, Randomized, Blinded, Placebo-Controlled, First-in-Human, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APR002 Administered by Inhalation in Healthy Volunteers

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

COVID-19

Interventions

APR002DRUG

Active Investigational Product

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy men or women aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture. * Women can be of childbearing potential and must have been stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 (screening) and be willing to continue on the chosen contraceptive method * Male subjects should be willing to use a condom (with spermicide) to prevent pregnancy and drug exposure of a female partner and refrain from donating sperm or fathering a child from the day of the investigational product administration until 3 months * Have a body mass index (BMI) between 18 and 32 kg/m2 and weigh at least 45 kg. Exclusion Criteria: * History or presence of clinically significant medical (e.g., chronic obstructive pulmonary disease, asthma, COVID-19, etc.) or psychiatric condition or disease * Abnormal vital signs, after minutes rest, defined as any of the following (SBP \> 140 mmHg, Diastolic blood pressure (DBP) \> 90 mmHg, Heart rate \< 40 or \> 99 beats per minute) * Prolonged QTcF \> 450 ms or family history of long QT syndrome

Locations (1)

CMAX Clinical Research

Adelaide, South Australia, Australia

Outcomes

Primary Outcomes

Safety and tolerability of APR002 in healthy subjects as assessed by incidence of treatment-emergent adverse events according to CTCAE v5.0 criteria

Safety assessments will include evaluation of incidence of treatment-emergent adverse events (AEs) according to CTCAE v5.0 criteria, including vital signs, resting electrocardiogram (ECG) parameters, standard hematology, chemistry, urinalysis and other tests

Time frame: Screening up to Day 14

Secondary Outcomes

Pharmacokinetics of APR002 in healthy subjects as assessed by maximum plasma concentration (Cmax) towards determination of the optimal pharmacokinetic dose

Determination of maximum plasma concentration (Cmax)

Time frame: Day 1 to Day 3

Pharmacokinetics of APR002 in healthy subjects as assessed by time to maximum concentration (Tmax) towards determination of the optimal pharmacokinetic dose

Determination of time to maximum concentration

Time frame: Day 1 to Day 3

Pharmacokinetics of APR002 in healthy subjects as assessed by plasma exposure (AUC0-t, AUC0-inf) determination of the optimal pharmacokinetic dose

Determination of plasma exposure (AUC0-t, AUC0-inf)

Time frame: Day 1 to Day 3

Pharmacokinetics of APR002 in healthy subjects as assessed by terminal elimination half life (t1/2) determination of the optimal pharmacokinetic dose

Determination of terminal half life

Time frame: Day 1 to Day 3

Pharmacokinetics of APR002 in healthy subjects as assessed by apparent volume of distribution during the terminal elimination phase after inhalation (extravascular) administration for determination of the optimal pharmacokinetic dose

Data from ClinicalTrials.gov

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