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NCT07408232RecruitingPhase 1/2

A Phase 1/2 Study in Healthy Volunteers and Participants With Autosomal Dominant Retinitis Pigmentosa (RHO-adRP)

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

Source: ClinicalTrials.gov · Last updated 24 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
18 (estimated)
First submitted
6 Feb 2026
Start date
10 Mar 2026
Primary completion date
1 Nov 2028
Lead sponsor
Octant, Inc.
NCT number
NCT07408232

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 18
  • From 10 Mar 2026 to the primary completion date, 1 Nov 2028
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Retina Foundation of the Southwest
Coordinator of this site? Confirm its status
DallasUnited StatesRecruiting
Casey Eye Institute
Coordinator of this site? Confirm its status
PortlandUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.