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

An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Safety and the Pharmacokinetics of AD-118 Compared to AD-1181 in Healthy Adult Volunteers

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07717749
Enrollment
74
Registered
2026-07-21
Start date
2026-07-24
Completion date
2026-08-01
Last updated
2026-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Heart Failure

Brief summary

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

Interventions

DRUGAD-118, AD-1181

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

Sponsors

Addpharma Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 64 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Area under the plasma concentration-time curve during dosing interval (AUCt)[Time Frame: pre-dose (0hour) to 36hours]AUCt of AD-118
Maximum concentration of drug in plasma (Cmax)Time Frame: pre-dose (0hour) to 36hours]Cmax of AD-118

Countries

South Korea

Contacts

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 22, 2026