A Dose Escalation Phase 1 Study of HXN5003 in Healthy Participants
ConditionAtopic Dermatitis
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorHelixon Biotechnology (Suzhou) Co., Ltd
About this trial
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.
Eligibility criteria
Qualifiers
Participants must sign an Institutional Review Board (IRB) approved informed consent form before any study specific procedure.
Male and female participants aged between 18 to 55 years, inclusive.
Participants must have a body mass index between 18 to 32 kg/m2, inclusive.
Able to participate and comply with all study procedures and restrictions
Disqualifiers
Females who are pregnant, planning to become pregnant, or lactating during the trial.
Participant who has history or evidence of any active or suspected infection within the past 14 days prior to randomization;
Participant who has known positive tuberculin skin test or recent exposure to an individual with active tuberculosis (TB), or current clinical or laboratory evidence of active TB.
Participant who has history of malignancy within 5 years before randomization, excluding localized basal cell carcinoma or cutaneous squamous cell carcinoma of the skin that have been resected or cured..
Trial design
Treatments tested in this trial
- HXN5003
- Placebo
Treatment groups
28 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov