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Safety, Tolerability, PK and PD of ADX-850 in Participants With Hypertension

PHASE1RECRUITING

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

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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)

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-03-21

Primary completion: 2025-12-31

Study completion finish: 2026-06-30

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT06205628

Intervention or treatment

DRUG: ADX-850

DRUG: Placebo

DRUG: Angiotensin Receptor Blockers

Conditions

• Hypertension
• Hypertension,Essential

Condition: Hypertension, Hypertension,Essential
DRUG: ADX-850 and other drugs
Adelaide, South Australia, Australia and more
Sponsor: ADARx Pharmaceuticals, Inc.

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Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

CMAX Clinical Research

Research sites nearby

Select from list below to view details:

CMAX Clinical Research
Adelaide, South Australia, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: PART 1 - Active ADX-850 administered to patients with hypertension For Cohort 1 in Part 1 (SAD), 8 participants will be randomized in a 3:1 ratio; 6 participants to active (ADX-850) : 2 participants to control (matched placebo). Randomization will be on Day 1. Initially, 2 sentinel participants (1 active and 1 placebo) will be randomized and dosed. The sentinel participants will be evaluated for safety. The investigator's assessment and the independent medical monitor will decide upon the randomization and dosing of the 6 remaining participants (5 active and 1 placebo) according to the randomization schedule. For Cohort 2, the option either to enroll 8 or expand to 16 patients in a 3:1 ratio will be made following review of Cohort 1. For Cohorts 3 and 4, 16 patients will be randomized in a 3:1 ratio; 12 patients to active (ADX-850) : 4 patients to control (matched placebo).	DRUG: ADX-850 siRNA duplex oligonucleotide
PLACEBO_COMPARATOR: PART 1 - Placebo administered to patients with hypertension For Cohort 1 in Part 1 (SAD), 8 participants will be randomized in a 3:1 ratio; 6 participants to active (ADX-850) : 2 participants to control (matched placebo). Randomization will be on Day 1. Initially, 2 sentinel participants (1 active and 1 placebo) will be randomized and dosed. The sentinel participants will be evaluated for safety. The investigator's assessment and the independent medical monitor will decide upon the randomization and dosing of the 6 remaining participants (5 active and 1 placebo) according to the randomization schedule. For Cohort 2, the option either to enroll 8 or expand to 16 patients in a 3:1 ratio will be made following review of Cohort 1. For Cohorts 3 and 4, 16 patients will be randomized in a 3:1 ratio; 12 patients to active (ADX-850) : 4 patients to control (matched placebo).	DRUG: Placebo Saline
EXPERIMENTAL: PART 2 - Active ADX-850 administered to patients with hypertension This will be initiated at the dose level determined by the Safety Review Committee from SAD in Part 1. The treatment of hypertension patients is an open-label study.	DRUG: ADX-850 siRNA duplex oligonucleotide
EXPERIMENTAL: PART 2 - Active ADX-850 plus ARB therapy administered to patients with hypertension Following ADX-850 dosing in Part 2, patients with remaining elevated blood pressure will additionally receive regular dosing of an angiotensin receptor blocker as an as-indicated concomitant therapy.	DRUG: ADX-850 siRNA duplex oligonucleotide

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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
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 outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
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
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
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
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
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
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
PART 1 - Biomarker Activity in Patients with Hypertension	To characterize the change from baseline in plasma AGT concentration	365 days
PART 2 - Biomarker Activity in Patients with Hypertension	To characterize the change from baseline in plasma AGT concentration	365 days

Frequently Asked Questions

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References

Clinical Trials Gov: Safety, Tolerability, PK and PD of ADX-850 in Participants With Hypertension