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NCT07735728

A First-in-Human Study of ZE66-0205 in Healthy Volunteers

StatusRecruiting
PhasePhase 1
Primary completion (estimated)
Track this trial

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Record History

All 3 versions: 2 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Recruitment opened Show 4 more changesShow less
    • Eligibility criteria expanded, about 29 words
    • Start date changed from estimate of Aug 15, 2026 to Aug 31, 2026
    • Secondary endpoints: details revised at 3 of 9 entries
    • Site details revised
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Incidence of treatment-emergent adverse events (TEAEs)
Timeframe: From the first dose on Day 1 through the End-of-Study visit on Day 8 (±1 day)
Incidence of serious adverse events (SAEs)
Timeframe: From the first dose on Day 1 through the End-of-Study visit on Day 8 (±1 day)
Change from Baseline in body weight
Timeframe: Baseline to Day 8 (±1 day)
Change from Baseline in systolic and diastolic blood pressure
Timeframe: Baseline through Day 8 (±1 day)
Change from Baseline in pulse rate
Timeframe: Baseline through Day 8 (±1 day)
Change from Baseline in respiratory rate
Timeframe: Baseline through Day 8 (±1 day)
Change from Baseline in body temperature
Timeframe: Baseline through Day 8 (±1 day)
Change from Baseline in electrocardiogram parameters
Timeframe: Baseline through Day 8 (±1 day)
Participants with clinically significant post-Baseline clinical laboratory abnormalities
Timeframe: Baseline through Day 8 (±1 day)

Secondary (9)

Maximum observed plasma concentration (Cmax) of ZE66-0205
Time to maximum observed plasma concentration (Tmax) of ZE66-0205
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-last)
Area under the plasma concentration-time curve from time 0 to 24 hours (AUC0-24)
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)
Show 4 moreShow less
Apparent terminal elimination half-life (t1/2) of ZE66-0205
Terminal elimination rate constant (lambda z) of ZE66-0205
Total apparent body clearance after oral administration (CL/F) of ZE66-0205
Apparent volume of distribution after oral administration (Vz/F) of ZE66-0205

Arms and interventions

PlaceboPlacebo comparator

Matching placebo. Two participants in each planned cohort will receive placebo capsules that match ZE66-0205 in appearance. Placebo will be administered orally under the same dosing and meal conditions as the corresponding active cohort. If twice-daily dosing is evaluated, placebo participants will receive a second dose approximately 12 hours after the first dose.

Experimental: Cohort 1Experimental

ZE66-0205 50 mg. Six participants will receive a single oral 50 mg dose on Day 1 under fasted conditions.

Experimental: Cohort 2Experimental

ZE66-0205 nominal 100 mg. Six participants will receive the SRC-confirmed oral dose on Day 1. The nominal dose is 100 mg; the actual dose may be adjusted based on emerging safety, PK, and PD data. Fed conditions or twice-daily dosing may be evaluated if selected by the SRC.

Experimental: Cohort 3Experimental

ZE66-0205 nominal 200 mg. Six participants will receive the SRC-confirmed oral dose on Day 1. The nominal dose is 200 mg; the actual dose may be adjusted based on emerging safety, PK, and PD data. Fed conditions or twice-daily dosing may be evaluated if selected by the SRC.

Experimental: Cohort 4Experimental

ZE66-0205 nominal 300 mg. Six participants will receive the SRC-confirmed oral dose on Day 1. The nominal dose is 300 mg; the actual dose may be adjusted based on emerging safety, PK, and PD data. Fed conditions or twice-daily dosing may be evaluated if selected by the SRC.

Drugs: ZE66-0205, Placebo

Sites

1 site in 1 country

  • Scientia Clinical Research LtdRandwick, New South Wales, Australia