Phase 1/2 Study of OPK-88006 in Healthy and Presumed MASH Participants

Part of paid clinical trials in Miami, Florida.

Sponsor
OPKO Health, Inc.
Study ID
NCT07512427
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • OPK-88006 — DRUG
    Administered by subcutaneous injection
  • Placebo — DRUG
    Administered by subcutaneous injection

Study Details

Two-part Phase 1/2 study of OPK-88006, including an open-label SAD phase in healthy participants and a double-blind, randomized, placebo-controlled MAD phase in participants with presumed MASH, to evaluate safety, PK, and MASH related pharmacodynamic changes compared to placebo.

Key Dates

First listed
Apr 6, 2026
Start date
Jul 24, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SAD - Cohort 1 OPK-88006
  • Experimental: SAD - Cohort 2 OPK-88006
  • Experimental: SAD - Cohort 3 OPK-88006
  • Experimental: MAD - OPK-88006/Placebo

Primary Outcome Measure

SAD - OPK-88006 maximum plasma concentration (Cmax) [ Time Frame: 2 hours to 1 week ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
OPKO study siteMiamiFlorida33143
OPKO Site

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OPKO study site· Miami, FL

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