A Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of KR23248 Capsules in Healthy Adult Subjects

Sponsor
Jiangxi Kvvit Pharmaceutical Co., Ltd.
Study ID
NCT07585383
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • KR23248 — DRUG
    Participants will recieve a single oral dose of KR23248
  • Matching Placebo — DRUG
    Participants will recieve placebo

Study Details

This study aims to investigate the safety, tolerability and pharmacokinetic characteristics of KR23248 capsules in healthy subjects. This study will be conducted in China. It will enroll male and female participants aged 18 years to 45 years.

Key Dates

First listed
May 13, 2026
Start date
May 19, 2026
Status verified
May 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

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

Arms

  • Experimental: Part 1 cohort 1
    SAD Cohort 1: single oral dose of 0.5mg KR23248 capsule
  • Experimental: Part 1 cohort 2
    SAD Cohort 2: single oral dose of 1.0mg KR23248 capsule
  • Experimental: Part 1 cohort 3
    SAD Cohort 3: single oral dose of 2.0mg KR23248 capsule
  • Experimental: Part 1 cohort 4
    SAD Cohort 4: single oral dose of 3.0mg KR23248 capsule
  • Experimental: Part 1 cohort 5
    SAD Cohort 5: single oral dose of 4.5mg KR23248 capsule
  • Experimental: Part 1 cohort 6
    SAD Cohort 6: single oral dose of 6.0mg KR23248 capsule
  • Placebo Comparator: Part 1 cohort 7
    SAD cohort 7: single oral dose of placebo capsule
  • Experimental: Part 2 KR23248 2.0mg
    MAD: Multiple oral doses of 2.0mg KR23248 capsules administered once daily for 14 consecutive days
  • Placebo Comparator: Part 2 Placebo
    MAD: Multiple oral doses of placebo capsules administered once daily for 14 consecutive days

Primary Outcome Measure

Incidence of adverse events (AEs), serious adverse events（SAEs）, drug-related AEs, and AEs leading to study withdrawal [ Time Frame: SAD:Day 1 to Day14 MAD:Day1 to Day28 ]

Central Contacts

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