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

Sponsor
Apros Therapeutics, Inc (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05268198
Collaborator
CMAX Clinical Research Pty Limited (Other), Avance Clinical (Other), Global Health Drug Discovery Institute (Other)
48
2
9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Detailed 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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
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
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention/Treatment

Single dose, oral inhalation (nebuliser solution)

Drug: APR002
APR002
Other Names:
  • TLR7 agonist
  • Placebo Comparator: Placebo

    Placebo

    Drug: APR002
    APR002
    Other Names:
  • TLR7 agonist
  • Outcome Measures

    Primary Outcome Measures

    1. Safety and tolerability of APR002 in healthy subjects as assessed by incidence of treatment-emergent adverse events according to CTCAE v5.0 criteria [Screening up to Day 14]

      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

    Secondary Outcome Measures

    1. Pharmacokinetics of APR002 in healthy subjects as assessed by maximum plasma concentration (Cmax) towards determination of the optimal pharmacokinetic dose [Day 1 to Day 3]

      Determination of maximum plasma concentration (Cmax)

    2. Pharmacokinetics of APR002 in healthy subjects as assessed by time to maximum concentration (Tmax) towards determination of the optimal pharmacokinetic dose [Day 1 to Day 3]

      Determination of time to maximum concentration

    3. Pharmacokinetics of APR002 in healthy subjects as assessed by plasma exposure (AUC0-t, AUC0-inf) determination of the optimal pharmacokinetic dose [Day 1 to Day 3]

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

    4. Pharmacokinetics of APR002 in healthy subjects as assessed by terminal elimination half life (t1/2) determination of the optimal pharmacokinetic dose [Day 1 to Day 3]

      Determination of terminal half life

    5. 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 [Day 1 to Day 3]

      Determination of volume of distribution (CL/F and Vz/F)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Apros Therapeutics, Inc
    • CMAX Clinical Research Pty Limited
    • Avance Clinical
    • Global Health Drug Discovery Institute

    Investigators

    • Study Director: Aaron Weitzman, Apros Therapeutics, Inc

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Apros Therapeutics, Inc
    ClinicalTrials.gov Identifier:
    NCT05268198
    Other Study ID Numbers:
    • APR002-NEB-001
    First Posted:
    Mar 7, 2022
    Last Update Posted:
    Mar 7, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 7, 2022