A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Orally Administered TIX100 in Healthy Subjects

Part of paid clinical trials in Chula Vista, California.

Sponsor
TIXiMED, Inc.
Study ID
NCT07675590
Phase
PHASE1
Status
Recruiting

Conditions

  • Health Adult Subjects
  • Obesity & Overweight

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • TIX100 — DRUG
    oral administration over 28 days
  • Placebo — DRUG
    oral administration over 28 days

Study Details

Randomized, Placebo-controlled Study to determine the safety and tolerability of multiple oral doses of TIX100 administered daily for 28 days to otherwise healthy overweight/obese subjects.

Key Dates

Start date
Jun 22, 2026
Status verified
Jun 2026
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
18 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: TIX100 40mg BID
    oral administration over 28 days
  • Active Comparator: TIX100 80mg BID
    oral administration over 28 days
  • Active Comparator: TIX100 120MG BID
    oral administration over 28 days
  • Placebo Comparator: Placebo
    oral administration over 28 days

Primary Outcome Measure

Safety and Tolerability [ Time Frame: Day 1 to Day 35 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
ProSciento, INCChula VistaCalifornia91911-

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