NCT07089043

A Study in Subjects With Neurogenic Orthostatic Hypotension

A Single-Blind Dose-Ranging Study in Subjects With Neurogenic Orthostatic Hypotension to Evaluate the Effect of CST-3056 on Symptoms and Signs of Orthostatic Hypotension

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: CuraSen Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a study to evaluate the effects of CST-3056 on orthostatic symptoms and signs in subjects with neurogenic orthostatic hypotension (nOH).

Detailed description

This is a study to evaluate the effects of CST-3056 on orthostatic symptoms in subjects with nOH. Subjects who use direct or indirect α1-AR agonists for treatment of nOH will need to discontinue those treatments for at least 1 day or 5 half-lives (whichever is longer) prior to assessment of orthostatic measures during Screening, and again prior to initiation of dosing for study drug on Day 1. Following confirmation of eligibility, subjects will be enrolled and participate in a single-blind dose ranging study. Single oral doses of CST-3056 will be administered once-daily for five days (Days 1 through 4 and the Optimal Dose Day \[Day 5\]), as tolerated. The Individual Optimal Dose will be determined based on observations for each subject over Day 1 through Day 4, including standing blood pressure, and safety/tolerability of the dose. Between 3-7 days after discharge from the in-patient stay, the Investigator or designee will contact the subject by telephone to review the subject's health status. Any adverse events reported by phone will be recorded and followed as medically appropriate as determined by the Investigator.

Conditions

• Neurogenic Orthostatic Hypotension

Interventions

Type	Name	Description
DRUG	CST-3056	Administered as an oral solution
DRUG	Placebo	Administered as an oral solution

Timeline

• Start date: 2025-09-12
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2025-07-28
• Last updated: 2026-02-27

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study