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

Summary

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

Conditions

• Neuropathic Pain
• Diabetic Neuropathies
• Post 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

Sponsors & Collaborators

• Seoul National University Hospital

  collaborator OTHER

• JMackem Co., Ltd

  lead INDUSTRY

Principal Investigators

• Seung-Hwan Lee, MD. Ph.D · Seoul National University Clinical Trials Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

55 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-12-05

Primary Completion

2025-04-30

Completion

2025-09-30

Countries

• South Korea

Study Locations