A Pharmacodynamic Effect Study of AP301 in Healthy Volunteers

NCT06100627 | Completed Phase 1

• 1 other identifier: AP301-PD-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Subjects

Keywords

Pharmacodynamic; safety; tolerability; AP301; Healthy subjects

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Incidence and severity of adverse events (AEs)

  From screening to hospitalization and follow up periods, assessed up to 43 days

• Changes in clinical laboratory values

  From screening to hospitalization and follow up periods, assessed up to 43 days

• Abnormal electrocardiogram (ECG) readings and their clinical meaningfulness

  From screening to hospitalization and follow up periods, assessed up to 43 days

• Changes of ECG parameters and their clinical meaningfulness

  From screening to hospitalization and follow up periods, assessed up to 43 days

• Abnormal vital signs and their clinical meaningfulness

  From screening to hospitalization and follow up periods, assessed up to 43 days

Study Arms (4)

2.10 g/day of AP301

EXPERIMENTAL

Drug: AP301

4.20 g/day of AP301

EXPERIMENTAL

Drug: AP301

6.30 g/day of AP301

EXPERIMENTAL

Drug: AP301

8.40 g.day of AP301

EXPERIMENTAL

Drug: AP301

Interventions

AP301 DRUG

Orally administered

2.10 g/day of AP301; 4.20 g/day of AP301; 6.30 g/day of AP301; 8.40 g.day of AP301

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alebund Pty Ltd: lead

Study Sites (1)

Nucleus Network Pty Ltd

Melbourne, Victoria, 3004, Australia

Location

Study Officials

• Sam Francis, Doctor

  Nucleus Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 25, 2023
• Study Start: January 11, 2024
• Primary Completion: February 8, 2024
• Study Completion: February 28, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05

Locations

AU (1)