Phase 1 Study in Diabetes Mellitus(Fasting)

NCT ID: NCT06552182

Last Updated: 2024-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-17
• Study Completion Date: 2024-03-18

Brief Summary

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

Detailed Description

An Open-label, Randomized, Fasting, 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.

Conditions

Diabetes; Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

HUC2-344

Intervention Type: DRUG

per oral

HUC2-344-R1, HUC2-344-R2

Intervention Type: DRUG

per oral

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.

Group Type: EXPERIMENTAL

HUC2-344

Intervention Type: DRUG

per oral

HUC2-344-R1, HUC2-344-R2

Intervention Type: DRUG

per oral

Interventions

HUC2-344

per oral

Intervention Type: DRUG

HUC2-344-R1, HUC2-344-R2

per oral

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Huons Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Seunghyeon Kang

Role: PRINCIPAL_INVESTIGATOR

H+YANGGI HOSPITAL

Locations

Huons

Seoul, , South Korea

Countries

South Korea

Other Identifiers

HUC2-344-1_FA

Identifier Type: -

Identifier Source: org_study_id