GNS-3545 for Idiopathic Pulmonary Fibrosis

Overseen By GNS-3545 Study Team

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Genosco Inc.

Must not be taking: CYP affecting drugs

Disqualifiers: Psychiatric conditions, Hepatic impairment, Cardiovascular, others

Compensation: Varies

Number of Visits: 1

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called GNS-3545 to understand its safety and effects on healthy adults. Participants will receive either a single dose or multiple doses over two weeks to observe their body's reactions compared to those taking a placebo (a pill with no active medicine). The goal is to gather safety data before progressing to patients with idiopathic pulmonary fibrosis, a lung disease that causes scarring and breathing difficulties. Ideal participants are healthy non-smokers who have been nicotine-free for at least three months. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial requires participants to avoid using medications, supplements, or substances that may affect certain enzymes, drug transporters, blood pressure, or heart rhythm within specified periods before starting the study. It's best to discuss your current medications with the study team to see if they are allowed.

Is there any evidence suggesting that GNS-3545 is likely to be safe for humans?

Research has shown that GNS-3545 is currently undergoing testing to determine its safety for people. This drug is in the early testing phase, so researchers are still assessing its safety. During these initial tests, they observe participants' reactions to the drug, monitor for any side effects (unwanted reactions), and study how the drug functions in the body.

As a Phase 1 trial, it primarily involves healthy volunteers. The main goal is to understand how the body processes the drug and to identify any immediate health issues. While specific information on side effects is not yet available, Phase 1 trials are a crucial first step to ensure a treatment's safety before it is administered to more people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about GNS-3545 for treating idiopathic pulmonary fibrosis because it potentially offers a novel approach compared to current standard treatments like antifibrotic drugs, which primarily aim to slow disease progression. GNS-3545 is believed to target a different pathway involved in the fibrosis process, which might lead to more effective management of the disease. This unique mechanism of action could result in better outcomes for patients by not only slowing down the progression but possibly improving lung function. Additionally, the treatment's design for both single and multiple dosing could provide flexibility and convenience in how it's administered.

What evidence suggests that GNS-3545 might be an effective treatment for idiopathic pulmonary fibrosis?

Research has shown that GNS-3545 is under investigation as a potential treatment for idiopathic pulmonary fibrosis (IPF), a serious lung disease. In this trial, participants will receive either GNS-3545 or a placebo. As this treatment is still in the early testing stages, limited information exists about its effectiveness in people. The researchers aim to determine if GNS-3545 can block processes that cause lung scarring, a major issue in IPF. Early studies suggest that targeting these processes could slow or reduce lung damage. However, further research is necessary to establish the effectiveness and safety of GNS-3545 for people with IPF. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for healthy adults who can participate in a study testing GNS-3545, a potential treatment for Idiopathic Pulmonary Fibrosis. Specific eligibility criteria are not provided, but typically participants should have no significant health issues.

Inclusion Criteria

Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, or vital signs, as deemed by the PI or designee

No ECG findings of clinical significance as judged by the PI or qualified designee

Understands the study procedures in the ICF and be willing and able to comply with the protocol

Exclusion Criteria

History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing

I have had liver problems.

I am at high risk for problems if my blood pressure drops.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD)

Participants receive a single dose of GNS-3545 or placebo to assess safety and pharmacokinetics

Up to 8 days

1 visit (in-person)

Multiple Ascending Dose (MAD)

Participants receive multiple doses of GNS-3545 or placebo once daily for 14 consecutive days to assess safety and pharmacokinetics

14 days

Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 17 days

What Are the Treatments Tested in This Trial?

Interventions

• GNS-3545

Trial Overview The study is assessing the safety and effects of different doses of GNS-3545 compared to a placebo. It's divided into two parts: one where single doses are given (SAD) and another with multiple doses (MAD). The impact of food on the drug's absorption will also be evaluated.

How Is the Trial Designed?

Group I: GNS-3545 Experimental Treatment 1 Intervention

Part 1 (SAD): Six participants will be randomized to receive a single dose of GNS-3545 at the assigned dose level, while two participants will receive matching placebo. Part 2 (MAD): Six participants will be randomized to receive multiple doses of GNS-3545 at the assigned dose level once daily for 14 consecutive days, while two participants will receive matching placebo.

Group II: GNS-3545 Placebo Placebo Group 1 Intervention

Part 1 (SAD): Six participants will be randomized to receive a single dose of GNS-3545 at the assigned dose level, while two participants will receive matching placebo. Part 2 (MAD): Six participants will be randomized to receive multiple doses of GNS-3545 at the assigned dose level once daily for 14 consecutive days, while two participants will receive matching placebo.

Who Is Running the Clinical Trial?

Genosco Inc.

Lead Sponsor

Citations

1. ichgcp.net ichgcp.net/clinical-trials-registry/NCT07225296

GNS-3545 in Idiopathic Pulmonary Fibrosis - Clinical Trials ... This is a randomized, double-blind, placebo-controlled Phase 1 study of SAD (Part 1) and MAD (Part 2) of orally administered GNS-3545 in ...

2. sigma.larvol.com sigma.larvol.com/disease.php?DiseaseId=19288&tab=News

Idiopathic Pulmonary Fibrosis News The use of IPF, a biomarker that can be rapidly obtained, in the diagnosis of AIS is expected to yield beneficial outcomes in patient management, particularly ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/condition/511/idiopathic-pulmonary-fibrosis

Idiopathic Pulmonary Fibrosis Clinical Research Trials The data will be recorded continuously from baseline to 5 minutes after the test is over. The distance the patient walked will also be recorded. Patients that ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT00532233?term=AREA%5BBasicSearch%5D(il-13)&rank=5

NCT00532233 | SD, IL-13 Production Rate in IPF Most clinical studies have one primary outcome measure, but some have more than one. ... The main reason for the clinical trial. The types of primary purpose are: ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10693523/

Current and Future Treatment Landscape for Idiopathic ... Idiopathic pulmonary fibrosis (IPF) remains a fatal and incurable disease despite the use of approved antifibrotic drugs. Development of novel ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07225296

A Single and Multiple Ascending Dose Study to Evaluate ... This is a randomized, double-blind, placebo-controlled Phase 1 study of SAD (Part 1) and MAD (Part 2) of orally administered GNS-3545 in ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32767182/

Safety of Nintedanib in Patients with Idiopathic Pulmonary ... The safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis (IPF) have been characterized using data from clinical trials.