A Phase 1 Study to Evaluate the Safety and Effects of a Single Dose of HCXT-2001 Tablets and HCXT-2001 Tablets(A) in Healthy Adults.

Sponsor
Shanghai Peptidstar Therapeutics Limited
Study ID
NCT07792928
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • HCXT-2001 Tablets — DRUG
    Two tablets taken orally in a fasted state
  • Placebo — DRUG
    Two tablets taken orally in a fasted state
  • HCXT-2001 Tablets(A) — DRUG
    Two tablets taken orally in a fasted state
  • HCXT-2001 Tablets — DRUG
    One tablet taken orally in a fasted state
  • Placebo — DRUG
    One tablet taken orally in a fasted state
  • HCXT-2001 Tablets(A) — DRUG
    One tablet taken orally in a fasted state

Study Details

The goal of this intervention study is to assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of HCXT-2001 Tablets and HCXT-2001 Tablets(A) in Healthy Participants. The main parameters it aims to answer are: Does a single dose of HCXT-2001 Tablets and HCXT-2001 Tablets(A) in healthy participants impact the Safety, Tolerability, Pharmacokinetics, and Immunogenicity profiles? This study will be a - randomized, double blind, placebo-controlled study.

Key Dates

First listed
Aug 28, 2026
Start date
Aug 14, 2026
Status verified
Jul 2026
Primary completion
Nov 10, 2026
Completion
Nov 10, 2026

Study Design

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

Arms

  • Experimental: HCXT-2001 Tablets - Cohort 1
  • Experimental: HCXT-2001 Tablets - Cohort 2
  • Placebo Comparator: HCXT-2001 Tablets - Placebo Cohort 1
  • Experimental: HCXT-2001 Tablets(A) - Cohort 3
  • Experimental: HCXT-2001 Tablets(A) - Cohort 4
  • Placebo Comparator: HCXT-2001 Tablets(A) - Placebo Cohort 3
  • Placebo Comparator: HCXT-2001 Tablets - Placebo Cohort 2
  • Placebo Comparator: HCXT-2001 Tablets(A) - Placebo Cohort 4

Primary Outcome Measure

Number of participants with AEs,SEAs, with abnormal - vital signs,physcial examinations,clinical laboratory results ,12-lead ECGs and stool routine tests [ Time Frame: Day 1 to Day 50 ]

Central Contacts

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