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NCT07408232From ClinicalTrials.govRecruiting

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

  • Retinitis Pigmentosa

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
Octant, Inc.
Enrolment target
18
Started
10 March 2026
Main results due
1 November 2028
Study sites
2
Registry updated
24 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(2)

  • Casey Eye Institute

    Portland, Oregon, United States

    Recruiting

  • Retina Foundation of the Southwest

    Dallas, Texas, United States

    Recruiting

Showing 2 of 2 sites. 2 of the 2 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07408232. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Phase 1/2 Study in Healthy Volunteers and Participants With Autosomal Dominant Retinitis Pigmentosa (RHO-adR | Trialion