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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05268198
• Other study ID #: APR002-NEB-001
• Status: Completed
• Phase: Early Phase 1
• Start date: March 20, 2023
• Est. completion date: July 27, 2023

Study information

• Verified date: August 2023
• Source: Global Health Drug Discovery Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 27, 2023
• Est. primary completion date: June 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• APR002
Active Investigational Product
• Placebo
Placebo

Locations

Country	Name	City	State
Australia	CMAX Clinical Research	Adelaide	South Australia

Sponsors (3)

Lead Sponsor	Collaborator
Global Health Drug Discovery Institute	Avance Clinical, CMAX Clinical Research Pty Limited

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Screening up to Day 14
Secondary	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)	Day 1 to Day 3
Secondary	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	Day 1 to Day 3
Secondary	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)	Day 1 to Day 3
Secondary	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	Day 1 to Day 3
Secondary	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	Determination of volume of distribution (CL/F and Vz/F)	Day 1 to Day 3