An Open-label, Single-center, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Intraocular Administration of FT-002 in Subjects With RPGR Mutation-associated X-linked Retinitis Pigmentosa.
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Genetic
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY
A clinical trial of gene therapy for patients with X-linked retinitis pigmentosa (XLRP).
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 8
Maximum Age: 45
Healthy Volunteers: f
View:
• Subjects that are willing and able to follow study procedures; 2.Males aged 8-45 years old at the time of signing the Informed Consent Form; 4.Subjects who are confirmed with variants of RPGR ;
Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Eye & ENT hospital of Fudan university
RECRUITING
Shanghai
Contact Information
Primary
Xinyan Li
xinyan.li@fronteratherapeutics.com
+86-021-58206061
Backup
Minghui Xue
minghui.xue@fronteratherapeutics.com
+86-021-58206061
Time Frame
Start Date: 2023-02-01
Estimated Completion Date: 2027-11-01
Participants
Target number of participants: 18
Treatments
Experimental: Low dose FT-002
Intraocular injection of a single low dose of FT-002
Experimental: Intermediate dose FT-002
Intraocular injection of a single Intermediate dose of FT-002
Experimental: High dose FT-002
Intraocular injection of a single High dose of FT-002
Related Therapeutic Areas
Sponsors
Collaborators: Peking Union Medical College Hospital, Henan Provincial People's Hospital, Eye & ENT Hospital of Fudan University
Leads: Frontera Therapeutics