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
This trial accepts healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
HXN5003
DrugSubcutaneous injection (SC) and single dose administration
Placebo
DrugContains the same inactive ingredients as those of HXN5003, but without the active ingredient.Subcutaneous injection (SC) and single dose administration
Treatment groups
28 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: Cohort 0Experimental treatment 1 intervention
Group B: Cohort 0 - PlaceboPlacebo comparator 1 intervention
Group C: Cohort 1Experimental treatment 1 intervention
Group D: Cohort 1 - PlaceboPlacebo comparator 1 intervention
Group E: Cohort 2Experimental treatment 1 intervention
Group F: Cohort 2 - PlaceboPlacebo comparator 1 intervention
Group G: Cohort 3Experimental treatment 1 intervention
Group H: Cohort 3- PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Safety and tolerability of HXN5003 in healthy participants following single dose
Incidence of adverse events, serious adverse events; Physical examination; Vital signs; 12-lead electrocardiogram parameters; Laboratory tests
Time frame
Baseline to Day 197Secondary outcomes
1
Maximum concentration of the drug (Cmax) following single dose of HXN5003 in healthy participants
Will be analyzed using standard non-compartmental analysis (NCA)
Time frame
Baseline to Day 1972
Time to peak concentration (Tmax) following single dose of HXN5003 in healthy participants
Will be analyzed using standard non-compartmental analysis (NCA)
Time frame
Baseline to Day 1973
Area under the concentration-time curve from time 0 to t (AUC0-t) following single dose of HXN5003 in healthy participants
Will be analyzed using standard non-compartmental analysis (NCA)
Time frame
Baseline to Day 1974
Immunogenicity evaluation of HXN5003 in healthy participants.
Incidence of anti-drug antibody after single ascending dose
Time frame
Baseline to Day 197Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: