A Dose Escalation Phase 1 Study of HXN5003 in Healthy Participants

Sponsor
Helixon Biotechnology (Suzhou) Co., Ltd
Study ID
NCT07549750
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • HXN5003 — DRUG
    Subcutaneous injection (SC) and single dose administration
  • Placebo — DRUG
    Contains the same inactive ingredients as those of HXN5003, but without the active ingredient.Subcutaneous injection (SC) and single dose administration

Study Details

The goal of this intervention study is to evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of HXN5003 in Healthy Participants.The main parameters it aims to answer are: 1. Does a single dose of HXN5003 in healthy participants impact the safety, tolerability and pharmacokinetic profiles? 2. Will immunogenicity of HXN5003 in healthy participants be altered? This study will be compared against a Placebo which contains the same inactive ingredients as those of HXN5003, but without the active ingredient.

Key Dates

First listed
Apr 24, 2026
Start date
May 27, 2026
Status verified
Mar 2026
Primary completion
Mar 18, 2027
Completion
Apr 16, 2027

Study Design

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

Arms

  • Experimental: Cohort 0
    3 participants
  • Placebo Comparator: Cohort 0 - Placebo
    1 Participant
  • Experimental: Cohort 1
    6 participants
  • Placebo Comparator: Cohort 1 - Placebo
    2 participants
  • Experimental: Cohort 2
    6 participants
  • Placebo Comparator: Cohort 2 - Placebo
    2 Participants
  • Experimental: Cohort 3
    6 participants
  • Placebo Comparator: Cohort 3- Placebo
    2 Participants

Primary Outcome Measure

Safety and tolerability of HXN5003 in healthy participants following single dose [ Time Frame: Baseline to Day 197 ]

Central Contacts

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