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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
Awards & highlights

Study Summary

This trial is testing the safety and tolerability of a new medication called HNC1058. It will be given to healthy volunteers in increasing doses by mouth. The results will be compared to a placebo

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of subjects with adverse events and concomitant medications
Secondary outcome measures
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

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.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Guangzhou Henovcom Bioscience Co. Ltd.Lead Sponsor
4 Previous Clinical Trials
189 Total Patients Enrolled
~15 spots leftby Jun 2025
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