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
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 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
Treatments tested in this trial
- HXN6005
- Placebo
Treatment groups
32 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov