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ENROLLING BY INVITATION
NCT06155487
PHASE1

A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Oral Administration of AJH-2947 in Healthy Korean and/or Caucasian Adult Male Subjects

Sponsor: JMackem Co., Ltd

View on ClinicalTrials.gov

Summary

Preliminary evaluate of pharmacokinetics, pharmacodynamics, safety and tolerability after oral administration of AJH-2947 in healthy Korean or Caucasian male subjects

Official title: A Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose, Phase 1 Clinical Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability After Oral Administration of AJH-2947 in Healthy Korean or Caucasian Male Subjects

Key Details

Gender

MALE

Age Range

19 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

68

Start Date

2023-12-05

Completion Date

2025-09

Last Updated

2024-10-17

Healthy Volunteers

Yes

Interventions

DRUG

AJH-2947 100 mg (SAD)

Oral Tablet, Single dose of AJH-2947 100 mg

DRUG

Placebo

Oral Tablet, Single dose of Placebo 100 mg

DRUG

AJH-2947 200 mg (SAD)

Oral Tablet, Single dose of AJH-2947 200 mg

DRUG

Placebo

Oral Tablet, Single dose of Placebo 200 mg

DRUG

AJH-2947 300 mg (SAD)

Oral Tablet, Single dose of AJH-2947 300 mg

DRUG

Placebo

Oral Tablet, Single dose of Placebo 300 mg

DRUG

AJH-2947 400 mg (SAD)

Oral Tablet, Single dose of AJH-2947 400 mg

DRUG

Placebo

Oral Tablet, Single dose of Placebo 400 mg

DRUG

AJH-2947 600 mg (SAD)

Oral Tablet, Single dose of AJH-2947 600 mg

DRUG

Placebo

Oral Tablet,Single dose of Placebo 600 mg

DRUG

AJH-2947 800 mg (SAD)

Oral Tablet, Single dose of AJH-2947 800 mg

DRUG

Placebo

Oral Tablet, Single dose of Placebo 800 mg

DRUG

AJH-2947 200 mg (MAD)

Oral Tablet, Multiple (once daily for 7days) oral dose of AJH-2947 200 mg

DRUG

Placebo

Oral Tablet, Multiple (once daily for 7days) oral dose of Placebo 200 mg

DRUG

AJH-2947 400 mg (MAD)

Oral Tablet,Multiple (once daily for 7days) oral dose of AJH-2947 400 mg

DRUG

Placebo

Oral Tablet, Multiple (once daily for 7days) oral dose of Placebo 400 mg

DRUG

AJH-2947 600 mg (MAD)

Oral Tablet, Multiple (once daily for 7days) oral dose of AJH-2947 600 mg

DRUG

Placebo

Oral Tablet, Multiple (once daily for 7days) oral dose of Placebo 600 mg

Locations (1)

Seoul National University Hospital

Seoul, South Korea