A Study to Evaluate the Safety, Pharmacokinetics of AD-118 and AD-1181 in Healthy Adult Subjects

Phase 1Not Yet RecruitingNCT07717749

Addpharma Inc.74 enrolled

Overview

A Study to Evaluate the Safety and Pharmacokinetics of AD-118 and AD-1181 Under Fasted Conditions in Healthy Adult Subjects

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Heart Failure

Interventions

AD-118, AD-1181DRUG

Single-dose oral administration of AD-118, according to randomized treatment sequence in a 2-period crossover design.

AD-118, AD-1181DRUG

Single-dose oral administration of AD-1181, according to randomized treatment sequence in a 2-period crossover design.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Body weight equal to or greater than 50kg and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit * Subjects aged 19 years or older and under 65 years at the screening visit Exclusion Criteria: * Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration * Other exclusions applied

Locations (1)

H Plus Yangji Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Area under the plasma concentration-time curve during dosing interval (AUCt)

AUCt of AD-118

Time frame: [Time Frame: pre-dose (0hour) to 36hours]

Maximum concentration of drug in plasma (Cmax)

Cmax of AD-118

Time frame: Time Frame: pre-dose (0hour) to 36hours]

Central Contacts

JaeHun Jung

CONTACT

+82-31-891-5683 jhjung@addpharma.co.kr

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.