A Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of HN01001 in Healthy Participants

A Randomized, Double-blinded, Partial-open, Placebo and Active-controlled, Single and Multiple Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of HN01001 in Healthy Participants

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0011578

Enrollment

Registered

2026-02-05

Start date

2026-02-23

Completion date

Unknown

Last updated

2026-02-09

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

Conditions

None listed

Interventions

Drug : *Double-blind All cohorts of the SAD/MAD study, except for the active comparator cohort, will be conducted under a double-blind design comparing HN01001 with placebo. The active comparator coho

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Healthy volunteers aged = 19 years and = 50 years - Body weight of = 50.0 kg and = 90.0 kg, with body mass index (BMI) of = 18.5 kg/m² and = 27.0 kg/m² at the time of screening

Exclusion criteria

Exclusion criteria: - History of drug abuse or positive on a urine drug test for abused drugs at the time of screening

Design outcomes

Primary

Measure	Time frame
Pharmacodynamics(gastric pH);Pharmacodynamics(serum gastrin concentration)	—

Secondary

Measure	Time frame
Pharmacogenomics	—

Countries

Korea, Republic of

Contacts

Public ContactSeungHwan Lee

Seoul National University Hospital

leejh413@snu.ac.kr+82-2-740-8910

Outcome results