Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05803850
Other study ID # HNC1058-A101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date March 28, 2023
Est. completion date March 8, 2024

Study information

Verified date March 2024
Source Guangzhou Henovcom Bioscience Co. Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of HNC1058 given to healthy subjects, compared to placebo.


Read more »

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
HNC1058 Capsules
HNC1058 Capsules/Placebos, single dose, PO, starting dose of 10 mg escalating up to 80 mg;HNC1058 Capsules/Placebos, 50 mg, single dose, FED.

Locations

Country Name City State
United States Syneos Health Miami Florida

Sponsors (1)

Lead Sponsor Collaborator
Guangzhou Henovcom Bioscience Co. Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of subjects with adverse events and concomitant medications To evaluate the safety and tolerability of HNC1058 in comparison with placebo after a single oral dose in healthy subjects in terms of AEs and CMs. Between screening and 7-9 days after the last dose
Secondary Number of subjects with vital sign measurements To evaluate the safety and tolerability of HNC1058 in comparison with placebo after a single oral dose in healthy subjects in terms of abnormal vital signs Between screening and 7-9 days after the last dose
Secondary Number of subjects with clinical laboratory test results o evaluate the safety and tolerability of HNC1058 in comparison with placebo after a single oral dose in healthy subjects in terms of abnormal clinical laboratory test results Between screening and 7-9 days after the last dose
See also
  Status Clinical Trial Phase
Recruiting NCT05570058 - Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of RXC007 in Idiopathic Pulmonary Fibrosis Phase 2
Recruiting NCT02807025 - Nasal, Tracheal and Bronchial Mucosal Lining Fluid(MLF) Sampling From Patients With Respiratory Diseases N/A
Recruiting NCT05895565 - A Multiple Ascending Doses (MAD) Study of PMG1015 in Idiopathic Pulmonary Fibrosis Subjects Phase 1
Completed NCT03211507 - Idiopathic Pulmonary Fibrosis Job Exposures Study
Completed NCT02503657 - Safety and Tolerability Study in Subjects With Idiopathic Pulmonary Fibrosis (IPF) Phase 2
Recruiting NCT03873298 - Inhaled NO in IPF and COPD During 6 Minute Walk Test Phase 2
Terminated NCT03864328 - A Phase 2b Study of Inhaled RVT-1601 for the Treatment of Persistent Cough in IPF Phase 2
Withdrawn NCT05349760 - A Phase 2 Study to Evaluate Safety and Efficacy of AMB-05X in Subjects With Idiopathic Pulmonary Fibrosis Phase 2
Completed NCT01266317 - Combined PEX, Rituximab and Steroids in Acute Idiopathic Pulmonary Fibrosis Exacerbations Phase 1/Phase 2
Recruiting NCT05147597 - Turkish Validity and Reliability of SGRQ-I
Completed NCT04503044 - ILAs in CT Lung Cancer Screening Population
Recruiting NCT04564183 - Advancing Prevention of Pulmonary Fibrosis
Recruiting NCT05190211 - Telerehabilitation in Patients With Idiopathic Pulmonary Fibrosis N/A
Recruiting NCT04263727 - A Study of Patients With Chronic Disease
Completed NCT05353556 - Effects of Home-based Inspiratory Muscle Training in Patients With IPF N/A
Completed NCT02976935 - Functional MR Lung Imaging Using Hyperpolarised 129Xe
Recruiting NCT05193136 - Sleep Hygiene, Sarcopenia, and Cognitive Function in Respiratory Disease
Recruiting NCT06181370 - Phase I Study to Assess Safety, Tolerability, PK and PD of AGMB-447 in Healthy Participants and Participants With IPF Phase 1
Not yet recruiting NCT02885961 - The Coagulation Cascade in Idiopathic Pulmonary Fibrosis N/A
Completed NCT02151435 - Prospective Evaluation of Biomarker Profiles in Idiopathic Pulmonary Fibrosis N/A