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

A Randomized, Double-blind, Placebo-controlled, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IW-1701 Administered Orally as Single Doses to Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02572349

Enrollment

Registered

2015-10-08

Start date

2015-10-31

Completion date

2015-12-31

Last updated

2019-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy Subjects

Brief summary

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.

Interventions

DRUGIW-1701

DRUGMatching Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

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.

Design outcomes

Primary

Measure	Time frame	Description
Assessment of the safety and tolerability of IW-1701 in healthy subjects via adverse events	From baseline up to 8 days	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026