NCT05282953

A Phase I/II Dose-escalating Study of the Safety, Tolerability and Efficacy of KIO-301 Administered Intravitreally to Patients With Retinitis Pigmentosa and Choroideremia (ABACUS)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Kiora Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A phase I/II dose-escalating study of the safety, tolerability and efficacy of KIO-301 administered intravitreally to patients with retinitis pigmentosa and choroideremia (ABACUS).

Detailed description

Main Study: assesses the safety and tolerability of single doses of KIO-301 when administered intravitreally to participants with retinitis pigmentosa and choroideremia. Sub-study: determines the test/re-test reliability of functional vision assessments in participants with low visual acuity.

Conditions

• Retinitis Pigmentosa
• Choroideremia
• Non-Syndromic Rod-Dominant Inherited Retinal Diseases

Interventions

Type	Name	Description
DRUG	KIO-301	KIO-301 intravitreal injection at ascending doses

Timeline

• Start date: 2022-11-10
• Primary completion: 2023-08-10
• Completion: 2026-07-01
• First posted: 2022-03-16
• Last updated: 2025-11-20

Locations

3 sites across 1 country: Australia