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Clinical Trials in the USA / NCT07408232
Recruiting Phase 1/2

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

NCT07408232 · tracked via the Priya Life Science USA tracker
Sponsor
Octant, Inc.
Phase
Phase 1/2
Started
2026-03-10
Last updated
2026-09-17

Condition(s) studied

Retinitis Pigmentosa

Investigational drug(s) / intervention(s)

Phase 1b/2: Cohort 1 - OCT-980 TabletPhase 1b/2: Cohort 2 - OCT-980 TabletPhase 1b/2: Cohort 3 - OCT-980 TabletPhase 1b/2: Cohort 4 - OCT-980 TabletPhase 1b/2: Cohort 5 - OCT-980 Tablet

Phase 1b/2: Cohort 1 - OCT-980 Tablet: OCT-980 tablets administered orally once daily at dose levels specified in the protocol

Phase 1b/2: Cohort 2 - OCT-980 Tablet: OCT-980 tablets administered orally once daily at dose levels specified in the protocol

Phase 1b/2: Cohort 3 - OCT-980 Tablet: OCT-980 tablets administered orally once daily at dose levels specified in the protocol

Phase 1b/2: Cohort 4 - OCT-980 Tablet: OCT-980 tablets administered orally once daily at dose levels specified in the protocol

Phase 1b/2: Cohort 5 - OCT-980 Tablet: OCT-980 tablets administered orally once daily at dose levels specified in the protocol

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Retina Foundation of the Southwest Dallas Texas Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07408232 on ClinicalTrials.gov ↗ ← All trials in the USA