A Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics of TIX100 in Healthy Subjects

Part of paid clinical trials in Chula Vista, California.

Sponsor
TIXiMED, Inc.
Study ID
NCT06800729
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • TIX100, an orally available inhibitor of thioredoxin-interacting protein — DRUG
    TIX100, an orally available inhibitor of thioredoxin-interacting protein
  • Placebo — DRUG
    placebo

Study Details

A Single Center, Single Dose, Randomized, Placebo-controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Orally Administered TIX100 in Healthy Subjects

Key Dates

Start date
Jan 31, 2025
Status verified
Jan 2025
Primary completion
May 31, 2025
Completion
May 31, 2025

Study Design

Enrollment
35 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: TIX100 20 mg
  • Active Comparator: TIX100 60 mg
  • Active Comparator: TIX100 100 mg
  • Active Comparator: TIX100 160 mg
  • Active Comparator: TIX100 200 mg
  • Placebo Comparator: placebo

Primary Outcome Measure

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: Day 7 ]

Locations (1)

FacilityCityStateZIPSite coordinators
ProSciento, Inc.Chula VistaCalifornia91911
Clinic Answering Service
[email protected]
619-427-1300

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By research site
ProSciento, Inc.· Chula Vista, CA

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