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

PHASE1Enrolling by invitationINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

December 5, 2023

Primary Completion Date

April 30, 2025

Study Completion Date

September 30, 2025

Conditions
Neuropathic PainDiabetic NeuropathiesPost Herpetic Neuralgia
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

Trial Locations (1)

03080

Seoul National University Hospital, Seoul

All Listed Sponsors
collaborator

Seoul National University Hospital

OTHER

lead

JMackem Co., Ltd

INDUSTRY