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NCT07448155

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of INCA033989 Following Subcutaneous or Intravenous Administration in Healthy Adult Participants

StatusActive, Not Recruiting
PhasePhase 1
Primary completion (estimated)
Track this trial

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Record History

All 6 versions: 6 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 32 words Show 5 more changesShow less
    • Enrollment closed, study ongoing
    • Final enrollment: 108 participants (planned 126)
    • Primary and study completion dates: Oct 19, 2026 to Nov 14, 2026
    • Secondary endpoints: details revised at 4 of 8 entries
    • Site details revised
  2. Trial status changed: Active, Not Recruiting → Recruitingv5 Show 5 more changesShow less
    • Enrollment increased: 72 → 126 participants
    • Eligibility criteria expanded, about 5 words
    • Trial arms changed: 4 → 7
    • Interventions: INCA033989 (Drug) to Bioavailability enhancer (Drug), INCA033989 (Drug)
    • Site details revised
  3. Primary and study completion pushed from May 23, 2026 to Oct 19, 2026v4
  4. Trial status changed: Recruiting → Active, Not Recruiting
    • Site details revised
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  6. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Pharmacokinetics Parameter: Cmax of INCA33989 following a single SC administration compared with a single IV infusion
Timeframe: Up to 12 weeks
Pharmacokinetics Parameter: AUClast of INCA33989 following a single SC administration compared with a single IV infusion
Timeframe: Up to 12 weeks
Pharmacokinetics Parameter: AUC0∞ of INCA33989 following a single SC administration compared with a single IV infusion
Timeframe: Up to 12 weeks
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Timeframe: Up to 12 weeks

Secondary (8)

Pharmacokinetics Parameter: tmax of INCA33989 following a single SC administration
Pharmacokinetics Parameter: t1/2 of INCA33989 following a single SC administration
Pharmacokinetics Parameter: CL/F of INCA33989 following a single SC administration
Pharmacokinetics Parameter: Vz/F of INCA33989 following a single SC administration
Pharmacokinetics Parameter: tmax of INCA33989 following a single IV infusion
Show 3 moreShow less
Pharmacokinetics Parameter: t1/2 of INCA33989 following a single IV infusion
Pharmacokinetics Parameter: CL of INCA33989 following a single IV infusion
Pharmacokinetics Parameter: Vss of INCA33989 following a single IV infusion

Arms and interventions

Cohort 1Experimental

INCA033989 will be administered at protocol defined dose administered as a SC injection.

Cohort 2Experimental

INCA033989 will be administered at protocol defined dose administered as a SC injection.

Cohort 3Experimental

INCA033989 will be administered at protocol defined dose administered as an IV infusion.

Cohort 4Experimental

INCA033989 will be administered at protocol defined dose administered as a SC injection.

Cohort 5Experimental

INCA033989 in combination with a bioavailability enhancer will be administered at protocol defined dose administered as a SC injection.

Cohort 6Experimental

INCA033989 in combination with a bioavailability enhancer will be administered at protocol defined dose administered as a SC injection.

Cohort 7Experimental

INCA033989 in combination with a bioavailability enhancer will be administered at protocol defined dose administered as a SC injection.

Drugs: INCA033989, Bioavailability enhancer

Sites

1 site in 1 country

  • Celerion Clinical Research UnitTempe, Arizona, United States