A Pharmacodynamic Effect Study of AP301 in Healthy Volunteers

A Randomized, Open-Label, Parallel Group, Phase 1 Study to Assess the Pharmacodynamic Effect of AP301 on Urinary Phosphorus Excretion in Healthy Volunteers

This is a randomized, open-label, parallel-group, phase 1 study to evaluate the PD effect of AP301 capsule in healthy volunteers. The study is planned to have 4 treatment arms: Arm 1: 2.10 g/day; arm 2: 4.20 g/day; arm 3: 6.30 g/day; arm 4: 8.40 g/day.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: AP301

Detailed Description

A total of 32 participants will participate in this study and the study consists of 3 periods such as screening period, hospitalization period and follow up period.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Zhen Liu; Phone Number: 86 021 60836212; Email: clinicaloperation@alebund.com

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Nucleus Network Pty Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Important Inclusion Criteria:

• Healthy male volunteers, 18-55 years of age
• Body mass index (BMI) 18-30 kg/m2 (exclusive) at screening.

Important Exclusion Criteria:

• Serum phosphorus is below 1.00 mmol/L at screening.
• History of significant gastrointestinal disease or disorder, major gastrointestinal surgeries, or cholecystectomy
• History or symptoms of any clinically significant kidney, liver, broncho-pulmonary, gastrointestinal, neurological, psychiatric, cardiovascular, endocrine/metabolic, hematological diseases, or cancer.
• History of specific allergies or allergic conditions or known allergies to the study drug as judged by the investigator, or any confirmed significant allergic reactions (urticaria or anaphylaxis) to any drug, or multiple drug allergies (non-active hay fever is acceptable). Allowing for childhood asthma, history of mild eczema that has had no flare ups for ≥5 years or is fully resolved.
• Known history of allergy to common food like milk or gluten, or lactose intolerance, or special diet habit for religious/life-style reasons, which might potentially jeopardize the participant's compliance of study diet.
• Any clinically significant concomitant disease, or condition or treatment that could interfere with the conduct of the study.
• Confirmed (based on the average of 3 separate resting blood pressure measurements, after at least 5 minutes rest) systolic blood pressure (BP) greater than 150 or less than 90 mmHg, and diastolic BP greater than 90 or less than 50 mmHg at screening.
• Clinically relevant ECG abnormalities on screening ECG.
• Estimated glomerular filtration rate (eGFR) ≤ 70 mL/min/1.73 m2.
• Positive test at screening of any of the following: Hepatitis B (HBsAg), Hepatitis C (HCV Ab) or human immunodeficiency virus (HIV-1 or HIV-2 Ab).
• Alanine aminotransferase (ALT) or aspartate transaminase (AST) > 1.5 × upper limit of normal (ULN), or any other clinically significant abnormalities in laboratory test results at screening.
• Dosed with a small-molecule or biologic investigational drug within 30 days or 90 days, respectively, or 5 half-lives (whichever is the longer) prior to first dose of this study.
• Positive urine test for drugs of abuse and/or positive alcohol test at screening.
• Any medical or social conditions that, in the view of investigator, might potentially jeopardize the participant's compliance of study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2.10 g/day of AP301	Drug: AP301; Orally administered
Experimental: 4.20 g/day of AP301	Drug: AP301; Orally administered
Experimental: 6.30 g/day of AP301	Drug: AP301; Orally administered
Experimental: 8.40 g.day of AP301	Drug: AP301; Orally administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary phosphorus excretion during AP301 administration	Average daily urinary phosphorus excretion during the 3 consecutive days of AP301 treatment	From the Day 1 to Day 4 after dosing, assessed up to 3 days
Effect of AP301 on urinary phosphorus excretion	Change of average daily urinary phosphorus excretion from 3 days before treatment to 3 days during treatment.	From Day -3 to Day 4 after dosing, assessed up to 6 days
Urinary calcium excretion during AP301 administration	Average daily urinary calcium excretion during the 3 consecutive days of AP301 treatment.	From the Day 1 to Day 4 after dosing, assessed up to 3 days
Effect of AP301 on urinary calcium excretion	Change of average daily urinary calcium excretion from 3 days before treatment to 3 days during treatment.	From Day -3 to Day 4 after dosing, assessed up to 6 days
Effect of AP301 on serum phosphorus and calcium	Changes of serum phosphorus and serum calcium from baseline to end of treatment.	From Day -3 to Day 4 after dosing, assessed up to 6 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of adverse events (AEs)	Number of participants with adverse events (AEs) and the intensity of adverse events. Number of participants with serious adverse events (SAEs) and the intensity of adverse events.	From screening to hospitalization and follow up periods, assessed up to 43 days
Changes in clinical laboratory values	Changes and their clinical meaningfulness in clinical laboratory values: Hematology, Biochemistry, Urinalysis	From screening to hospitalization and follow up periods, assessed up to 43 days
Abnormal electrocardiogram (ECG) readings and their clinical meaningfulness	ECG intervals (PR [PQ], QRS, QT, QTcF) and heart rate	From screening to hospitalization and follow up periods, assessed up to 43 days
Changes of ECG parameters and their clinical meaningfulness	ECG intervals (PR [PQ], QRS, QT, QTcF), heart rate, T-wave morphology and U-wave morphology.	From screening to hospitalization and follow up periods, assessed up to 43 days
Abnormal vital signs and their clinical meaningfulness	Blood pressure, heart rate and body temperature	From screening to hospitalization and follow up periods, assessed up to 43 days

Collaborators and Investigators

• Sponsor: Alebund Pty Ltd
• Investigators: Principal Investigator: Sam Francis, Doctor, Nucleus Network

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Actual): February 8, 2024
• Study Completion (Actual): February 24, 2024

Study Registration Dates

• First Submitted: October 17, 2023
• First Submitted That Met QC Criteria: October 20, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: tolerability; safety; Healthy subjects; Pharmacodynamic; AP301
• Other Study ID Numbers: AP301-PD-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No