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
1 other identifier
interventional
34
1 country
1
Brief Summary
An open-label, randomized, Fed, single-dose, 2-sequence, 2-period, crossover phase 1 study in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 diabetes
Started Apr 2024
Shorter than P25 for phase_1 diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2024
CompletedFirst Submitted
Initial submission to the registry
August 8, 2024
CompletedFirst Posted
Study publicly available on registry
August 13, 2024
CompletedAugust 13, 2024
August 1, 2024
2 months
August 8, 2024
August 11, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
After a single dose of HUC2-344, co-administration of HUC2-344-R1 and HUC2-344-R2
EXPERIMENTALTake 2 pills of comparative drugs first, and take 1 pill of IP after a 1 week of the break.
After co-administering HUC2-344-R1 and HUC2-344-R2 once, take single dose of HUC2-344 once.
EXPERIMENTALTake 1 pill of IP first, and take 2 pills of comparative drugs after a 1 week of the break.
Interventions
per oral
per oral
Eligibility Criteria
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
- +23 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Huons Co., Ltd.lead
Study Sites (1)
Huons
Seongnam-si, Gyeonggi-do, 13486, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seunghyeon Kang
H+YANGGI HOSPITAL
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2024
First Posted
August 13, 2024
Study Start
April 15, 2024
Primary Completion
June 10, 2024
Study Completion
June 10, 2024
Last Updated
August 13, 2024
Record last verified: 2024-08