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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date March 8, 2024
Est. primary completion date February 27, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: 1. Capable of understanding the written informed consent document; willingly provides valid, signed written informed consent; willing and able to comply with the schedule, requirements, and restrictions of the study. Are capable of giving informed consent and complying with study procedures. 2. Between the ages of 18 and 55 years (inclusive) at the time of Screening. 3. BMI between 18.0 and 32.0 kg/m2 (inclusive) at the time of Screening and have a body weight no less than 50 kg. 4. In good general health, as determined by the Investigator. 5. Female subjects must be non pregnant and non lactating. 6. 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). Refer to Section 6.4.1 for full details of reproductive requirements and acceptable methods of contraception for female subjects. 7. Male subjects with female partners of reproductive potential must agree to practice abstinence or to use a condom (male subject) plus an additional barrier method (female partner) of contraception for the duration of the study and for at least 90 days after dosing; must also agree to refrain from sperm donation for at least 90 days post dose. 8. Normal renal function as determined by Investigator following review of clinical laboratory test results, including eGFR as estimated using the CKD EPI equation. 9. Non smoker, with no use of any tobacco or nicotine containing products within 6 months prior to Day 1. Exclusion Criteria: 1. Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the Investigator. 2. Known or suspected malignancy. 3. History of pancreatitis or gall stones. 4. History of unexplained syncope, symptomatic hypotension, or hypoglycemia. 5. Family history of long QTc syndrome. 6. History of chronic diarrhea, malabsorption, unexplained weight loss, food allergies or intolerance. 7. Poor venous access. 8. Positive blood screen for human immunodeficiency virus (HIV), hepatitis B, hepatitis C, or hepatitis E. 9. Hospital admission or major surgery within 6 months prior to screening. 10. History of alcohol or prescription drug abuse within 9 months prior to screening. 11. Positive test result for alcohol or drugs of abuse (i.e., UDS) at screening or Admission. 12. Use of any prohibited medication(s) and/or substance(s), including: 1. use of any drugs known to induce or inhibit drug metabolism within 30 days prior to Day 1; 2. receipt of another investigational medication (EXCEPT biological compound) within 30 days or receipt of biological compound within 90 days (or 5 half lives, whichever is longer) prior to Day 1; 3. participation in an investigational device study within 30 days prior to Day 1. 4. routine consumption of the following within 14 days prior to Day 1: i. Prescription medication (except hormonal contraception for WOCBP), OTC medication, traditional Chinese medicine, or herbal medicine (within 14 days or 5 half lives, whichever is longer); ii. Vitamin, mineral, and other dietary supplements; iii. Grapefruit and grapefruit juice; e. donation of the following within the below specified timeframe prior to Day 1: i. bone marrow or peripheral stem cells within 90 days; ii. blood within 60 days; iii. plasma within 30 days. f. Any of the following activities within 72 hours prior to Day 1: i. strenuous exercise; ii. alcohol consumption; iii. consumption of caffeine-containing substances. 13. Loss of >500 mL blood (for any reason) within 90 days prior to Day 1. 14. For 50 mg cohort only: inability to completely consume a standardized high fat breakfast within 30 minutes. 15. Per investigator discretion, any other reason that would render a subject inappropriate for study participation.

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