Phase 1 Study in Diabetes Mellitus(Fasting)

NCT06552182 | Completed Phase 1

• 1 other identifier: HUC2-344-1_FA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes; Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• Cmax

  Maximum concentration of HUC2-344

  0,15,30,45minutes,1,1.25,1.5,2,2.5,3,4,5,6,7,8,12,24,48hours

• Tmax

  Time of concentration

  0,15,30,45minutes,1,1.25,1.5,2,2.5,3,4,5,6,7,8,12,24,48hours

• AUCt

  Area under the drug concentration-time curve

  0,15,30,45minutes,1,1.25,1.5,2,2.5,3,4,5,6,7,8,12,24,48hours

Study Arms (2)

After a single dose of HUC2-344, co-administration of HUC2-344-R1 and HUC2-344-R2

EXPERIMENTAL

Take 2 pills of comparative drugs first, and take 1 pill of IP after a 1 week of the break.

Drug: HUC2-344; Drug: HUC2-344-R1, HUC2-344-R2

After co-administering HUC2-344-R1 and HUC2-344-R2 once, take single dose of HUC2-344 once.

EXPERIMENTAL

Take 1 pill of IP first, and take 2 pills of comparative drugs after a 1 week of the break.

Drug: HUC2-344; Drug: HUC2-344-R1, HUC2-344-R2

Interventions

HUC2-344 DRUG

per oral

After a single dose of HUC2-344, co-administration of HUC2-344-R1 and HUC2-344-R2; After co-administering HUC2-344-R1 and HUC2-344-R2 once, take single dose of HUC2-344 once.

HUC2-344-R1, HUC2-344-R2 DRUG

per oral

After a single dose of HUC2-344, co-administration of HUC2-344-R1 and HUC2-344-R2; After co-administering HUC2-344-R1 and HUC2-344-R2 once, take single dose of HUC2-344 once.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Those who have clinically significant diseases or medical history below lists.
• Skin/mucous membranes
• Head and neck
• Eyes/appendages
• Ear, nose, and throat
• Thyroid/endocrine system
• Lungs/respiratory system
• Heart/circulatory system
• Abdomen/digestive system
• Kidney/urinary reproductive system
• Spine/musculoskeletal system
• Nervous/psychiatric system
• Blood/lymph/tumor
• Allergy/immune system
• Drug hypersensitivity

Sponsors & Collaborators

• Huons Co., Ltd.: lead

Study Sites (1)

Huons

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Seunghyeon Kang

  H+YANGGI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: healthy volunteers

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 13, 2024
• Study Start: January 17, 2024
• Primary Completion: February 15, 2024
• Study Completion: March 18, 2024
• Last Updated: August 13, 2024

Record last verified: 2024-08

Locations

KR (1)