Phase 1/2 Study of OPK-88006 in Healthy and Presumed MASH Participants
ConditionMASH
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorOPKO Health, Inc.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults aged 18-65 years.
BMI ≥27 and ≤35 kg/m².
Good general health per investigator assessment.
Willing to comply with contraception, trial procedures, and stable diet/exercise.
Disqualifiers
Significant uncontrolled medical or psychiatric history.
History of pancreatitis, cancer (within 5 years), or substance misuse.
Clinically significant abnormal labs (e.g., liver enzymes, low platelets) or ECG findings.
Recent use of prohibited medications (GLP-1 agonists, anti-obesity drugs).
Trial design
Design model
Parallel
Treatments tested in this trial
OPK-88006
DrugAdministered by subcutaneous injection
Placebo
DrugAdministered by subcutaneous injection
Treatment groups
30 Participants
are divided into 4 treatment groupsGroup A: SAD - Cohort 1 OPK-88006Experimental treatment 1 intervention
Group B: SAD - Cohort 2 OPK-88006Experimental treatment 1 intervention
Group C: SAD - Cohort 3 OPK-88006Experimental treatment 1 intervention
Group D: MAD - OPK-88006/PlaceboExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
SAD - OPK-88006 maximum plasma concentration (Cmax)
To assess Cmax of OPK-88006 after a single dose
Time frame
2 hours to 1 week2
SAD - OPK-88006 Time to peak (Tmax)
To assess Tmax of OPK-88006 after a single dose
Time frame
2 hours to 1 week3
SAD - OPK-88006 Elimination half-life (T1/2)
To assess T1/2 of OPK-88006 after a single dose
Time frame
10 hours to 200 hours4
SAD - Frequency of treatment emergent adverse events (TEAE)
TEAEs will be graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame
Up to 2 weeksSponsors and contacts
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Source ClinicalTrials.gov