Phase 1 Study in Diabetes Mellitus(Fed)

An Open-label, Randomized, Fed, Single-dose, 2-sequence, 2-period, Crossover Phase 1 Study to Evaluate the Pharmacokinetics and the Safety After Administration of HUC2-344 and Co-administration of HUC2-344-R1 and HUC2-344-R2 in Healthy Volunteers

An open-label, randomized, Fed, single-dose, 2-sequence, 2-period, crossover phase 1 study in healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Diabetes; Diabete Mellitus
• Intervention / Treatment: Drug: HUC2-344; Drug: HUC2-344-R1, HUC2-344-R2

Detailed Description

An Open-label, Randomized, Fed, Single-dose, 2-sequence, 2-period, Crossover Phase 1 Study to Evaluate the Pharmacokinetics and the Safety After Administration of HUC2-344 and Co-administration of HUC2-344-R1 and HUC2-344-R2 in Healthy Volunteers.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13486
      • Huons

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy adult aged over 19 at screening
• Those whose BMI is between 18kg/m2 and 30kg/m2
• Those weight over 50kg(female 45kg)
• Those who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc

Exclusion Criteria:

• Those who have clinically significant diseases or medical history below lists.

  1. Skin/mucous membranes
  2. Head and neck
  3. Eyes/appendages
  4. Ear, nose, and throat
  5. Thyroid/endocrine system
  6. Lungs/respiratory system
  7. Heart/circulatory system
  8. Abdomen/digestive system
  9. Kidney/urinary reproductive system
  10. Spine/musculoskeletal system
  11. Nervous/psychiatric system
  12. Blood/lymph/tumor
  13. Allergy/immune system
  14. Drug hypersensitivity
• Within 30 days prior to the first dose, the individual took medications significantly inducing or inhibiting drug-metabolizing enzymes such as barbiturates, or within 10 days prior to the first dose, took medications that could affect this study.
• Those who have participated in a bioequivalence study or other clinical trials and received investigational drugs within 6 months prior to the first dosing day.
• Within 8 weeks prior to the first dosing day, Those who have donated whole blood or within 2 weeks donated components, or received a blood transfusion within 4 weeks.
• Those who with a history of gastrointestinal resection surgery (excluding appendectomy or hernia repair) that could affect drug absorption, or those with gastrointestinal disorders.

• Within 1 month prior to the first dosing day, Those who meet the following conditions:

  1. For males, average alcohol consumption exceeding 21 drinks per week.
  2. For females, average alcohol consumption exceeding 14 drinks per week.
  3. Smoking more than an average of 20 cigarettes per day.

• Those who meet the following criteria:

  1. Known hypersensitivity reactions to active ingredients, excipients of investigational drugs, or non-quinolone drugs.
  2. Acute or chronic metabolic acidosis including type 1 diabetes mellitus, hyperglycemia, with or without ketoacidosis, or history of ketoacidosis.
  3. Estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73m² or severe and advanced renal impairment.
  4. End-stage renal disease or undergoing dialysis.
  5. Genetic issues such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
  6. Acute conditions affecting renal function such as dehydration, severe infection, cardiovascular collapse (shock), acute myocardial infarction, sepsis.
  7. Acute and unstable congestive heart failure.
  8. Receiving intravenous administration of iodinated contrast agents for radiographic studies.
  9. Diabetic ketoacidosis.
  10. Severe infections or severe systemic disorders.
  11. Malnutrition, starvation, cachexia, hypothalamic-pituitary dysfunction, or adrenal insufficiency.
  12. Acute or chronic conditions causing tissue hypoxia such as hepatic dysfunction, respiratory failure, acute myocardial infarction, shock, excessive alcohol consumption, dehydration, diarrhea, vomiting, or gastrointestinal disorders.
  13. Other reasons deemed unsuitable for participation in the clinical trial by the study investigator.
  14. For female subjects, pregnant, suspected pregnant, or lactating.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: After a single dose of HUC2-344, co-administration of HUC2-344-R1 and HUC2-344-R2; Take 2 pills of comparative drugs first, and take 1 pill of IP after a 1 week of the break.	Drug: HUC2-344; per oral; Drug: HUC2-344-R1, HUC2-344-R2; per oral
Experimental: After co-administering HUC2-344-R1 and HUC2-344-R2 once, take single dose of HUC2-344 once.; Take 1 pill of IP first, and take 2 pills of comparative drugs after a 1 week of the break.	Drug: HUC2-344; per oral; Drug: HUC2-344-R1, HUC2-344-R2; per oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum concentration of HUC2-344	0,1,2,3,4, 4.5,5.5,6,7,8,9,10,12,24,48hours
Tmax	Time of concentration	0,1,2,3,4, 4.5,5.5,6,7,8,9,10,12,24,48hours
AUCt	Area under the drug concentration-time curve	0,1,2,3,4, 4.5,5.5,6,7,8,9,10,12,24,48hours

Collaborators and Investigators

• Sponsor: Huons Co., Ltd.
• Investigators: Principal Investigator: Seunghyeon Kang, H+YANGGI HOSPITAL

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2024
• Primary Completion (Actual): June 10, 2024
• Study Completion (Actual): June 10, 2024

Study Registration Dates

• First Submitted: August 8, 2024
• First Submitted That Met QC Criteria: August 11, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 11, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: HUC2-344-1_FE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No