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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06205628
Other study ID # ADX-850-101
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date March 21, 2024
Est. completion date June 30, 2026

Study information

Verified date April 2024
Source ADARx Pharmaceuticals, Inc.
Contact Markus P Schlaich, MD
Phone +61892240382
Email markus.schlaich@uwa.edu.au
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The first-in-human Phase 1 study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ADX-850 in patients with hypertension.


Description:

The clinical study described in this protocol is a Phase 1, two-part, multi-center study evaluating safety, tolerability, PK, and PD of ADX-850. The study consists of two parts: - Randomized, double-blind, placebo-controlled, parallel group, single ascending dose (SAD) in patients with hypertension with up to 4 dose cohorts. For SAD cohorts and planned dosing; and - Open-label, parallel group, single fixed dose of ADX-850 in patients with hypertension. After ADX-850 dosing, patients with elevated blood pressure will additionally receive regular dosing of an ARB as an as-indicated concomitant therapy.


Recruitment information / eligibility

Status Recruiting
Enrollment 72
Est. completion date June 30, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Body mass index (BMI) between 18 and 35 kg/m2 - Body weight =55 kg - No use of antihypertensive medication for a minimum of 2 weeks or 5 half-lives - Access to and ability to use antihypertensive medication/access to emergency services to treat hyper- or hypotensive events - Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies - Willing and able to provide informed consent and comply with all study visits - Willing to start or switch to irbesartan as concomitant ARB therapy, if applicable (Part 2 only) Exclusion Criteria: - Any significant medical history - Secondary hypertension - Active malignancy and/or history of malignancy in the past 5 years - History of liver disease, Gilbert's syndrome, nonalcoholic steatohepatitis, severe steatosis, or abnormal liver function test - Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, red blood cell (RBC), hemoglobin, hematocrit, reticulocytes, gamma-glutamyl transferase (GGT), and creatinine must be within normal range at screening and prior to dosing - Any active infection or acute illness - Major surgery or significant traumatic injury occurring within 3 months - Any other conditions that, in the opinion of the Investigator or Sponsor, would make the participant unsuitable for inclusion, or could interfere with the participant participating in or completing the study - Mean sitting diastolic BP (DBP) =110 mmHg at any time prior to randomization. - Orthostatic hypotension - eGFR <60 mL/min/1.73m2 - Abnormal potassium levels <3.5 and >5 mmol/L - History or presence of clinically significant ECG abnormalities and corrected QTcF >450 ms prior to dosing - Positive serology tests (HepB, Hep C, HIV) - Use of unapproved prescription, vaccines, supplements/vitamins, or over-the counter medication - Treatment with another investigational product concurrently or within 30 days prior to the first study drug administration - Known hypersensitivity to any of the study drug ingredients - Pregnancy, intent to become pregnant during the course of the study, or lactating women - History or presence of alcohol abuse - Night shift workers (regular working hours between 10:00 PM and 6:00 AM) - Known history of intolerance to ARB medication (Part 2 only)

Study Design


Intervention

Drug:
ADX-850
siRNA duplex oligonucleotide
Placebo
Saline
Angiotensin Receptor Blockers
Angiotensin receptor blocker

Locations

Country Name City State
Australia CMAX Clinical Research Adelaide South Australia
Australia Linear Clinical Research Nedlands Western Australia

Sponsors (2)

Lead Sponsor Collaborator
ADARx Pharmaceuticals, Inc. ADARx Australia Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary PART 1 - Safety in Patients with Hypertension To evaluate the safety and tolerability of ADX-850 in hypertension patients by incidence, relationship, and severity of adverse events and serious adverse events 365 days
Primary PART 2 - Safety in Patients with Hypertension To evaluate the safety and tolerability of ADX-850 in hypertension patients by incidence, relationship, and severity of adverse events, adverse events of special interest, and serious adverse events 365 days
Secondary PART 1 - Plasma Pharmacokinetics in Patients with Hypertension To characterize the Pharmacokinetics of ADX-850 by measuring the Maximum Observed Concentration (Cmax) based on concentration in plasma 8 days
Secondary PART 1 - Plasma Pharmacokinetics in Patients with Hypertension To characterize the Pharmacokinetics of ADX-850 by measuring the Dose-Normalized Maximum Observed Concentration (Cmax/D) based on concentration in plasma 8 days
Secondary PART 1 - Plasma Pharmacokinetics in Patients with Hypertension To characterize the Pharmacokinetics of ADX-850 by measuring the Time to Maximum Observed Concentration (Tmax) based on concentration in plasma 8 days
Secondary PART 1 - Plasma Pharmacokinetics in Patients with Hypertension To characterize the Pharmacokinetics of ADX-850 by measuring the Area Under the Concentration-Time Curve (AUC) based on concentration in plasma 8 days
Secondary PART 1 - Plasma Pharmacokinetics in Patients with Hypertension To characterize the Pharmacokinetics of ADX-850 by measuring the Dose-Normalized Area Under the Concentration-Time Curve (AUC/D) based on concentration in plasma 8 days
Secondary PART 1 - Plasma Pharmacokinetics in Patients with Hypertension To characterize the Pharmacokinetics of ADX-850 by measuring the terminal half-life (t½) based on concentration in plasma 8 days
Secondary PART 1 - Biomarker Activity in Patients with Hypertension To characterize the change from baseline in plasma AGT concentration 365 days
Secondary PART 2 - Biomarker Activity in Patients with Hypertension To characterize the change from baseline in plasma AGT concentration 365 days
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