What side effects are associated with this type of intervention?

The most common treatments for Idiopathic Pulmonary Fibrosis (IPF) are nintedanib and pirfenidone. Nintedanib frequently causes gastrointestinal symptoms, particularly diarrhea, and can also lead to liver enzyme elevations, necessitating regular monitoring. Pirfenidone commonly causes gastrointestinal issues such as nausea and dyspepsia, as well as skin-related side effects like rash and photosensitivity. Both medications are associated with a reduction in disease progression but require careful management of their side effects.

What prior FDA approvals exist?

The FDA has approved two antifibrotic medications for the treatment of Idiopathic Pulmonary Fibrosis (IPF): nintedanib and pirfenidone. Nintedanib, a receptor blocker for multiple tyrosine kinases, slows the rate of disease progression in IPF and was approved based on its ability to reduce the decline in lung function. Pirfenidone, which also slows disease progression and reduces acute exacerbations, was approved following clinical trials demonstrating its efficacy in decreasing the decline in forced vital capacity (FVC) and improving survival rates. Both medications are not curative but help manage the progression of IPF.

What other types of research exist?

Promising novel alternatives to HNC1058 for IPF patients in 2024 include senicapoc, which is predicted to show greater benefit than pirfenidone and nintedanib, and pamrevlumab, an anti-connective tissue growth factor therapy that has shown positive results in clinical trials. Both drugs have demonstrated potential in slowing disease progression and improving patient outcomes.

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HNC1058 Capsules for Idiopathic pulmonary fibrosis

Phase 1

Waitlist Available

Research Sponsored by Guangzhou Henovcom Bioscience Co. Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female subjects must be of non childbearing potential, or agree to use an appropriate method(s) of contraception throughout the entire duration of study participation, and have negative pregnancy test results at Screening (serum) and Admission (urine).

Normal renal function as determined by Investigator following review of clinical laboratory test results, including eGFR as estimated using the CKD EPI equation.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up between screening and 7-9 days after the last dose

Summary

This trial tests a new drug called HNC1058 in healthy people to see if it is safe and well-tolerated when taken by mouth.

Who is the study for?

This trial is for healthy adults aged 18-55 with a BMI of 18.0-32.0, weighing at least 50 kg, and non-smokers for the past six months. Women must not be pregnant or breastfeeding and either not able to have children or use contraception; men must also agree to use contraception.

What is being tested?

The study tests the safety and tolerability of HNC1058 capsules in comparison to a placebo when given as single ascending oral doses to healthy subjects.

What are the potential side effects?

Since this is an initial test of HNC1058 in humans, potential side effects are unknown but will be closely monitored for anything from mild reactions at the dose site to more significant health changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not able to have children, or I agree to use birth control during the study and have a negative pregnancy test.

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My kidney function is normal as confirmed by tests.

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I understand the study details, agree to participate, and can follow the study plan.

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My BMI is between 18 and 32, and I weigh at least 50 kg.

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I am between 18 and 55 years old.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ between screening and 7-9 days after the last dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~between screening and 7-9 days after the last dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and between screening and 7-9 days after the last dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of subjects with adverse events and concomitant medications

Secondary study objectives

Number of subjects with clinical laboratory test results

Number of subjects with vital sign measurements

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: HNC1058 Capsules FEDExperimental Treatment1 Intervention

HNC1058 Capsules, food effect, Single dose

Group II: HNC1058 CapsulesExperimental Treatment1 Intervention

HNC1058 Capsules, single ascending doses

Group III: HNC1058 Placebos FEDPlacebo Group1 Intervention

HNC1058 Placebos, food effect, Single dose

Group IV: HNC1058 PlacebosPlacebo Group1 Intervention

HNC1058 Placebos, single ascending doses

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

HNC1058 Capsules

2023

Completed Phase 1

~40

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Nintedanib and pirfenidone are the most common treatments for Idiopathic Pulmonary Fibrosis (IPF). Nintedanib is a tyrosine kinase inhibitor that targets multiple pathways involved in fibrosis, including the vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF), and platelet-derived growth factor (PDGF) receptors. By inhibiting these pathways, nintedanib reduces fibroblast activity and slows the progression of fibrosis. Pirfenidone, on the other hand, has anti-inflammatory and antifibrotic properties. It inhibits the synthesis of pro-fibrotic cytokines and reduces fibroblast proliferation. These mechanisms are crucial for IPF patients as they help to slow disease progression, improve lung function, and potentially extend survival, addressing the chronic and progressive nature of the disease.