NCT05517603

A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Of AJ201 In Patients

A Phase 1/2a, Randomized, Double-Blind, Placebo-Controlled, First-In-Patient Study Of AJ201 To Evaluate Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics In Adults With Spinal And Bulbar Muscular Atrophy (SBMA)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: AnnJi Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1/2a randomized, double-blind study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of study drug AJ201 in subjects with Spinal and Bulbar Muscular Atrophy (SBMA).

Conditions

• Spinal and Bulbar Muscular Atrophy
• Kennedy's Disease

Interventions

Type	Name	Description
DRUG	AJ201	Administered orally
DRUG	Placebo	Administered orally

Timeline

• Start date: 2023-02-28
• Primary completion: 2024-04-08
• Completion: 2024-04-08
• First posted: 2022-08-26
• Last updated: 2024-08-15

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study