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RecruitingNCT07408232Updated Sep 24, 2026

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

A Phase 1/2 interventional study of Phase 1b/2: Cohort 1 - OCT-980 Tablet and Phase 1b/2: Cohort 2 - OCT-980 Tablet in Retinitis Pigmentosa, sponsored by Octant, Inc.. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by Octant, Inc. · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
18
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Octant, Inc. is evaluating OCT-980, an oral small molecule corrector for the treatment of patients with rhodopsin (RHO)-associated autosomal dominant retinitis pigmentosa (RHO-adRP). There is no known cure and no currently approved therapy for RHO-adRP, a disease of the retina characterized by progressive loss of vision.

This study is comprised of a Phase 1a in healthy volunteers, which was conducted in Australia and is now complete.

The phase 1b/2 study is an open-label, multi-center multiple ascending dose escalation (MAD) to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of multiple-ascending doses of OCT-980 for up to 48 weeks, in participants with a genetic diagnosis of Rhodopsin-associated, autosomal dominant Retinitis Pigmentosa (RP).

RHO-adRP participants are currently being recruited for the phase 1b/2 study in the US.

02

Conditions studied

  • Retinitis Pigmentosa

Keywords

  • Rhodopsin-associated autosomal dominant Retinitis Pigmentosa
  • RHO-adRP
  • Retinitis Pigmentosa
  • Inherited Retinal Disease
  • autosomal dominant Retinitis Pigmentosa
  • Retinitis Pigmentosa 4
  • RP4
  • RP
  • Eye Diseases
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
18 participants (estimated)

Study arms

  • Experimental
    Phase 1b/2: OCT-980 Cohort 1

    OCT-980 tablets administered orally once daily.

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

  • Experimental
    Phase 1b/2: OCT-980 Cohort 2

    OCT-980 tablets administered orally once daily.

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

  • Experimental
    Phase 1b/2: OCT-980 Cohort 3

    OCT-980 tablets administered orally once daily.

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

  • Experimental
    Phase 1b/2: OCT-980 Cohort 4

    OCT-980 tablets administered orally once daily.

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

  • Experimental
    Phase 1b/2: OCT-980 Cohort 5

    OCT-980 tablets administered orally once daily.

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

Interventions

  • DrugPhase 1b/2: Cohort 1 - OCT-980 Tablet

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

  • DrugPhase 1b/2: Cohort 2 - OCT-980 Tablet

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

  • DrugPhase 1b/2: Cohort 3 - OCT-980 Tablet

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

  • DrugPhase 1b/2: Cohort 4 - OCT-980 Tablet

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

  • DrugPhase 1b/2: Cohort 5 - OCT-980 Tablet

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

05

What researchers measure

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

06

Study locations

2 of 2 sites recruiting
  • Casey Eye Institute
    Portland, Oregon 97239, United States
    Recruiting
  • Retina Foundation of the Southwest
    Dallas, Texas 75231-5080, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07408232
Lead sponsor
Octant, Inc.
Responsible party
Sponsor
First posted
Feb 13, 2026
Start date
Mar 10, 2026
Primary completion
Nov 1, 2028 (estimated)
Completion
Nov 1, 2028 (estimated)
Last update
Sep 24, 2026

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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