Retinitis PigmentosaRare diseaseGeneticsFirst-in-humanVision and hearingDrugPhase 1, Phase 2
What this study is
This integrated Ph1/2 clinical study is to assess the safety, tolerability and pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of OCT-980 in healthy volunteers and participants with RHO-adRP.
What's being tested
- Phase 1b/2: Cohort 1 - OCT-980 Tablet
Intervention · DRUG
- Phase 1b/2: Cohort 2 - OCT-980 Tablet
Intervention · DRUG
- Phase 1b/2: Cohort 3 - OCT-980 Tablet
Intervention · DRUG
- Phase 1b/2: Cohort 4 - OCT-980 Tablet
Intervention · DRUG
- Phase 1b/2: Cohort 5 - OCT-980 Tablet
Intervention · DRUG
All interventions
OCT-980 tablets administered orally once daily at dose levels specified in the protocol
Study details
- Official title
- A Phase 1/2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of OCT-980 in Healthy Volunteers and Participants With Autosomal Dominant Retinitis Pigmentosa
- Sponsor
- Octant, Inc.
- Conditions
- Retinitis Pigmentosa
- Enrolling
- 18 people
- Starts
- 2026-03-10
- Est. completion
- 2028-11-01
- Design
- Open-label, non-randomized, sequential groups, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Phase 1b/2 is active. Inclusion Phase 1b/2 (Multiple Ascending Dose Escalation in RHO-adRP Patients) Inclusion:; Participants must have a diagnosis of Rhodopsin-associated, autosomal dominant Retinitis Pigmentosa confirmed by a genetic test that is implemented in accordance with the relevant national requirements; Male or female greater than or equal to age 18 (inclusive) at the time of signing the informed consent form; Have a body weight >50kg, with a body mass index (BMI) from 18.0 to 35.0 kg/m^2 (inclusive) at screening; Best Corrected Visual Acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study (ETDRS) > 55; Other than their diagnosis of RHO-adRP, be in good general health, as determined by the Investigator; Have sufficient venous access to allow blood sampling for pharmacokinetic analysis and safety laboratory samples Phase 1b/2 (Multiple Ascending Dose Escalation in RHO-adRP Patients) Exclusion:; Females who are pregnant or breastfeeding; Evidence of any other significant ocular (other than RHO-adRP) and non-ocular disease/ disorder; Lifetime history of ocular surgery; Any prior or current ophthalmologic gene therapy; Has a history of major surgery, severe trauma, or bone fracture within 12 weeks before the first dose of the investigational product or planned surgery within 4 weeks after the end of the study
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openCasey Eye Institute
Portland, Oregon, United States
- Brian Heimdahl, BA · Contact503-494-9771heimdahb@ohsu.edu
- Aidan Flieger · Contactflieger@ohsu.edu
- Lesley Everett, MD · Principal investigator
RecruitingRetina Foundation of the Southwest
Dallas, Texas, United States
- Charlene Nwajei · Contactcnwajei@retinafoundation.org
- Jennifer Herrera · Contactjherrera@retinafoundation.org
- Mark Pennesi, MD · Principal investigator
Recruiting
Study team
Sponsor
Octant, Inc.
Study ID OCT-980-101
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.