NCT07408232

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
25mo left

Started Mar 2026

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Mar 2026Nov 2028

First Submitted

Initial submission to the registry

February 6, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
25 days until next milestone

Study Start

First participant enrolled

March 10, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

September 24, 2026

Status Verified

September 1, 2026

Enrollment Period

2.6 years

First QC Date

February 6, 2026

Last Update Submit

September 22, 2026

Conditions

Retinitis Pigmentosa

Keywords

Rhodopsin-associated autosomal dominant Retinitis PigmentosaRHO-adRPRetinitis PigmentosaInherited Retinal Diseaseautosomal dominant Retinitis PigmentosaRetinitis Pigmentosa 4RP4RPEye Diseases

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of multiple doses (Phase 1b/2) of OCT-980 in participants with a genetic diagnosis of RHO-adRP.

    Time Frame: From Baseline to Week 60 (Ph 1b/2)

Study Arms (5)

Phase 1b/2: OCT-980 Cohort 1

EXPERIMENTAL

OCT-980 tablets administered orally once daily.

Drug: Phase 1b/2: Cohort 1 - OCT-980 Tablet

Phase 1b/2: OCT-980 Cohort 2

EXPERIMENTAL

OCT-980 tablets administered orally once daily.

Drug: Phase 1b/2: Cohort 2 - OCT-980 Tablet

Phase 1b/2: OCT-980 Cohort 3

EXPERIMENTAL

OCT-980 tablets administered orally once daily.

Drug: Phase 1b/2: Cohort 3 - OCT-980 Tablet

Phase 1b/2: OCT-980 Cohort 4

EXPERIMENTAL

OCT-980 tablets administered orally once daily.

Drug: Phase 1b/2: Cohort 4 - OCT-980 Tablet

Phase 1b/2: OCT-980 Cohort 5

EXPERIMENTAL

OCT-980 tablets administered orally once daily.

Drug: Phase 1b/2: Cohort 5 - OCT-980 Tablet

Interventions

Phase 1b/2: Cohort 1 - OCT-980 TabletDRUG

OCT-980 tablets administered orally once daily at dose levels specified in the protocol

Phase 1b/2: OCT-980 Cohort 1
Phase 1b/2: Cohort 2 - OCT-980 TabletDRUG

OCT-980 tablets administered orally once daily at dose levels specified in the protocol

Phase 1b/2: OCT-980 Cohort 2
Phase 1b/2: Cohort 3 - OCT-980 TabletDRUG

OCT-980 tablets administered orally once daily at dose levels specified in the protocol

Phase 1b/2: OCT-980 Cohort 3
Phase 1b/2: Cohort 4 - OCT-980 TabletDRUG

OCT-980 tablets administered orally once daily at dose levels specified in the protocol

Phase 1b/2: OCT-980 Cohort 4
Phase 1b/2: Cohort 5 - OCT-980 TabletDRUG

OCT-980 tablets administered orally once daily at dose levels specified in the protocol

Phase 1b/2: OCT-980 Cohort 5

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Casey Eye Institute

Portland, Oregon, 97239, United States

RECRUITING

Retina Foundation of the Southwest

Dallas, Texas, 75231-5080, United States

RECRUITING

MeSH Terms

Conditions

Retinitis PigmentosaRetinitis Pigmentosa 4Eye Diseases

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryRetinal DystrophiesRetinal DegenerationRetinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Octant adRP Clinical Operations

CONTACT

+1-510-500-5956adrpclinicaltrials@octant.bio

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Phase 1b/2 in RHO-adRP participants is being conducted in the US.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2026

First Posted

February 13, 2026

Study Start

March 10, 2026

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2028

Last Updated

September 24, 2026

Record last verified: 2026-09

Locations

US(2)