Trial of IW-1701 (A Stimulator of Soluble Guanylate Cyclase (sGC)) in Healthy Volunteers

Cyclerion Therapeutics24 enrolled

Overview

The objectives of the study are to assess the safety and tolerability of a range of single doses of IW-1701 when administered as oral capsules to healthy subjects, to determine the pharmacokinetic profile and pharmacodynamics effects of a range of single doses of IW-1701 when administered as oral capsules to healthy subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

IW-1701DRUG

Matching PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion: * Between 18 and 60 years old at the Screening Visit; * Women of childbearing potential must have a negative pregnancy test and must agree to use double-barrier contraception; * BMI \> 18.5 and \< 32.0 kg/m2 at the Screening Visit; * In overall good health with no clinically significant laboratory, ECG, or physical exam findings; * Other inclusion criteria per protocol. Exclusion: * History of any clinically-significant medical condition; * Other exclusion criteria per protocol.

Locations (1)

Ironwood Investigational Site

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Assessment of the safety and tolerability of IW-1701 in healthy subjects via adverse events

The primary objectives of this study are to assess the safety and tolerability of single ascending dosage levels of IW-1701 versus placebo in healthy subjects.

Time frame: From baseline up to 8 days

Data from ClinicalTrials.gov

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