To Evaluate the Safety and Pharmacokinetic Characteristics of AJU-C711 in Healthy Adults

NCT06931327 | Completed Phase 1

• 1 other identifier: 24PHL11501
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and pharmacokinetic characteristics of AJU-C711 in healthy adults

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (2)

• AUCt of AJU-C711

  Pre-dose (0 hr) 10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72 hr

• Cmax of AJU-C711

  Pre-dose (0 hr) 10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72 hr

Study Arms (2)

Sequence A

EXPERIMENTAL

Period 1: Reference Drug, single dose Period 2: Test Drug, single dose

Drug: Test Drug; Drug: Reference Drug

Sequence B

EXPERIMENTAL

Period 1: Test Drug, single dose Period 2: Reference Drug, single dose

Drug: Test Drug; Drug: Reference Drug

Interventions

Test Drug DRUG

AJU-C711

Sequence A; Sequence B

Reference Drug DRUG

C711R

Sequence A; Sequence B

Eligibility Criteria

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

You may qualify if:

• Healthy adult volunteers aged ≥ 19-year-old
• Weight ≥ 50kg (man) or 45kg (woman), with calculated body mass index(BMI) of 18 to 30 kg/m2
• Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings
• Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ECG results during screening tests
• \. Those who agree to contraception during the participation of clinical trial 7. Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial

You may not qualify if:

• Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug
• Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month or the first administration of clinical trial drug within 10 days
• Those who donated whole blood within 8 weeks, received apheresis within 2 weeks, blood transfusion within 1 month or can't refrain from donating blood from the time of written consent until the end of the study
• Those who has a history of gastrointestinal disease or surgery which may affect the absorption of the drug
• Those who exceeding an alcohol consumption criteria Alcohol: Men - 21 glass/week, Women - 14 glass/week (1 glass: Soju 50 mL, liquor: 30mL or Beer 250mL)
• Those who has under
• Those who are hypersensitive to component of the Investigational product and have the medical history
• Those with active liver disease or persistent elevation of aminotransferase levels of unknown
• Those with severe hepatic impairment or biliary atresia and cholestasis
• Those taking cyclosporin
• Those with myopathy
• Those who has a disease history of diabetic mellitus, nephropathy, biliary obstruction, dihydropyridine sensitivity, angioedema
• Those who has Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
• Those who has a history of mental illness
• Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons

Sponsors & Collaborators

• AJU Pharm Co., Ltd.: lead

Study Sites (1)

Bumin Hospital, Seoul, Republic of South Korea

Seoul, South Korea

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Drug Evaluation

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic

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: April 9, 2025
• First Posted: April 17, 2025
• Study Start: March 29, 2025
• Primary Completion: April 16, 2025
• Study Completion: April 18, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

KR (1)