PORT-77 for Erythropoietic Protoporphyria
(EPP Trial)
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Portal Therapeutics, Inc.
Prior Safety DataThis treatment has passed at least one previous human trial
Trial Summary
What is the purpose of this trial?
A Phase 2a study of PORT-77 in adults with erythropoietic protoporphyria (EPP)
Research Team
CM
Chief Medical Officer
Principal Investigator
Portal Therapeutics, Inc.
Eligibility Criteria
Adults with a condition called erythropoietic protoporphyria (EPP) who experience symptoms even under treatment can join. They must understand English, follow sun exposure and contraception guidelines, have a BMI between 18.0-35.0 kg/m2, and weigh at least 50 kg.Inclusion Criteria
Able to read and understand English
Willing and able to avoid exposure to sunlight when outside of the clinical research site
Willing and able to follow protocol-specified contraception guidance
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Exclusion Criteria
History or presence of any illness or clinically significant medical or psychiatric condition or disease that, in the opinion of the PI or designee, might confound the results of the study or pose an additional risk to the participant by their participation in the study
Participation in another clinical study within 28 days or within 5 half-lives (if known), prior to screening
Estimated glomerular filtration rate <80 mL/min/1.73 m2 using the CKD-EPI equation at screening
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants receive PORT-77 or placebo for 9 days
9 days
Daily visits for dosing and monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment
2-4 weeks
Treatment Details
Interventions
- PORT-77
Trial Overview The trial is testing PORT-77 against a placebo to see if it helps with phototoxicity in EPP patients. Participants will be randomly assigned to receive either the real drug or a placebo for comparison.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PORT-77Experimental Treatment1 Intervention
Active
Group II: PlaceboPlacebo Group1 Intervention
Placebo
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Who Is Running the Clinical Trial?
Portal Therapeutics, Inc.
Lead Sponsor
Trials
1
Recruited
110+
Celerion
Industry Sponsor
Trials
85
Recruited
7,600+
Dr. Susan Thornton
Celerion
Chief Executive Officer since 2010
PhD in Molecular Biology from the University of Pennsylvania
Dr. Lorraine M. Rusch
Celerion
Chief Medical Officer since 2020
MD from an unspecified institution
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