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RecruitingPhase 1/Phase 2

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

Octant, Inc. · NCT07408232

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1, Phase 2
Target enrollment
18
US sites recruiting
2
Study start
March 10, 2026
Record last updated
September 24, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Phase 1b/2: Cohort 1 - OCT-980 Tablet; Phase 1b/2: Cohort 2 - OCT-980 Tablet; Phase 1b/2: Cohort 3 - OCT-980 Tablet; Phase 1b/2: Cohort 4 - OCT-980 Tablet; Phase 1b/2: Cohort 5 - OCT-980 Tablet

Conditions: Retinitis Pigmentosa

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Casey Eye Institute

    Portland, OR 97239

    Site contact: Brian Heimdahl, BA · 503-494-9771 · heimdahb@ohsu.edu

  • Retina Foundation of the Southwest

    Dallas, TX 75231-5080

    Site contact: Charlene Nwajei · cnwajei@retinafoundation.org

Study contacts (from the official record)

  • Octant adRP Clinical Operations · +1-510-500-5956 · adrpclinicaltrials@octant.bio
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