Single Ascending Doses (SAD) and Multiple Ascending Doses(MAD) Study of IG001119 in Healthy Adult Participants

Sponsor
Iongen Therapeutics Co., Ltd.
Study ID
NCT07618247
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Placebo — DRUG
    Tablets for oral administration.
  • IG001119 — DRUG
    Tablets for oral administration.

Study Details

The purpose of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IG001119 in Healthy Participants

Key Dates

First listed
Jun 1, 2026
Start date
Jun 4, 2026
Status verified
May 2026
Primary completion
Apr 30, 2027
Completion
May 30, 2027

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IG001119 Single Ascending Doses (SAD)
  • Placebo Comparator: Placebo Single Ascending Doses (SAD)
  • Experimental: IG001119 Multiple Ascending Doses(MAD)
  • Placebo Comparator: Placebo Multiple Ascending Doses(MAD)

Primary Outcome Measure

The incidence and severity of adverse events（AE） [ Time Frame: from ICF signing date to Day 10 ]

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