NCT06155487

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

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

• Status: Enrolling By Invitation
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: JMackem Co., Ltd · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2023-12-05
• Primary completion: 2025-04-01
• Completion: 2025-09-01
• First posted: 2023-12-04
• Last updated: 2024-10-17

Locations

1 site across 1 country: South Korea