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

Part of paid clinical trials in Dallas, Texas.

Sponsor
Octant, Inc.
Study ID
NCT07408232
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Retinitis Pigmentosa

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Phase 1b/2: Cohort 1 - OCT-980 Tablet — DRUG
    OCT-980 tablets administered orally once daily at dose levels specified in the protocol
  • Phase 1b/2: Cohort 2 - OCT-980 Tablet — DRUG
    OCT-980 tablets administered orally once daily at dose levels specified in the protocol
  • Phase 1b/2: Cohort 3 - OCT-980 Tablet — DRUG
    OCT-980 tablets administered orally once daily at dose levels specified in the protocol
  • Phase 1b/2: Cohort 4 - OCT-980 Tablet — DRUG
    OCT-980 tablets administered orally once daily at dose levels specified in the protocol
  • Phase 1b/2: Cohort 5 - OCT-980 Tablet — DRUG
    OCT-980 tablets administered orally once daily at dose levels specified in the protocol

Study Details

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.

Key Dates

First listed
Feb 13, 2026
Start date
Mar 10, 2026
Status verified
Sep 2026
Primary completion
Nov 1, 2028
Completion
Nov 1, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1b/2: OCT-980 Cohort 1
    OCT-980 tablets administered orally once daily.
  • Experimental: Phase 1b/2: OCT-980 Cohort 2
    OCT-980 tablets administered orally once daily.
  • Experimental: Phase 1b/2: OCT-980 Cohort 3
    OCT-980 tablets administered orally once daily.
  • Experimental: Phase 1b/2: OCT-980 Cohort 4
    OCT-980 tablets administered orally once daily.
  • Experimental: Phase 1b/2: OCT-980 Cohort 5
    OCT-980 tablets administered orally once daily.

Primary Outcome Measure

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Retina Foundation of the SouthwestDallasTexas75231-5080
Charlene Nwajei
[email protected]
Jennifer Herrera
[email protected]
Mark Pennesi, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Dallas, TX

By research site
Retina Foundation of the Southwest· Dallas, TX

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