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Safety, Tolerability, PK and PD of ADX-850 in Participants With Hypertension
The first-in-human Phase 1 study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ADX-850 in patients with hypertension.
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
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
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
| DRUG: ADX-850
|
PLACEBO_COMPARATOR: PART 1 - Placebo administered to patients with hypertension
| DRUG: Placebo
|
EXPERIMENTAL: PART 2 - Active ADX-850 administered to patients with hypertension
| DRUG: ADX-850
|
EXPERIMENTAL: PART 2 - Active ADX-850 plus ARB therapy administered to patients with hypertension
| DRUG: ADX-850
|
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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