Phase I Study of HXN6005 in Adult Healthy Participants
ConditionHealthy Volunteers (HV)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorHelixon Biotechnology (Suzhou) Co., Ltd
About this trial
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetic characteristics and pharmacodynamics of HXN6005 in Healthy Participants.
Researchers will compare HXN6005 to a placebo (a look-alike substance that contains no drug).
Participants will take a single dose of HXN6005 or placebo on Day 1, and visit the clinic for followup and tests per the protocol scheme.
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 35 kg/m2, inclusive.
Healthy participants, in the opinion of the Investigator and as determined by medical history, with normal or clinically acceptable physical examination, clinical laboratory tests and ECG results at Screening and before randomization.
Disqualifiers
Females who are pregnant, planning to become pregnant, or lactating during the trial;
History of febrile illness or evidence of any active or suspected infection within 30 days before randomization;
Participant at risk for tuberculosis;
History of malignancy within 5 years before randomization, except for non-melanoma skin cancers (e.g., basal cell carcinoma, squamous cell carcinoma) that have been successfully treated/excised for more than 12 months;
Trial design
Design model
Sequential
Treatments tested in this trial
HXN6005
Drugparticipants will receive a single subcutaneous dose of HXN6005 at escalating dose levels in Cohort 1-4,
Placebo
DrugParticipants will receive matching placebo across cohorts 1-4 of the study.
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Single-Ascending Dose (SAD) of HXN6005Experimental treatment 1 intervention
Group B: Single-Ascending Dose (SAD) of placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants Experiencing Adverse Events
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Time frame
Up to Day 141Secondary outcomes
1
Cmax
Maximum concentration after single ascending dose
Time frame
Up to Day 1412
Tmax
Time to reach maximum concentration after single ascending dose
Time frame
Up to Day 1413
t1/2
Half life after single ascending dose
Time frame
Up to Day 1414
AUC
Area under the concentration-time curve after single ascending dose
Time frame
Up to Day 141Other outcomes
1
Exploratory PD biomarker
Change from baseline in serum free TSLP concentration over time
Time frame
Up to Day 141Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov