Study of HX15001 in Adult Healthy Volunteers.
ConditionHealthy Volunteers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorHelixon Biotechnology (Suzhou) Co., Ltd
About this trial
This is a phase I, randomized, double-blinded, placebo-controlled, single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetic characteristics and pharmacodynamics of HX15001 in adult healthy participants.
The study consists of two parts: Part A involves single-dose escalation (Cohorts 1-7), and Part B involves multiple-dose escalation (Cohorts 8-9).
The primary objective of this study is to characterize the safety and tolerability of single and multiple doses of HX15001 in healthy subjects.
Eligibility criteria
Qualifiers
An informed consent document signed and dated by the subject.
Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive.
Have a Body mass index (BMI) of 18-32 kg/m2 , inclusive; with body weight ≥50 kg during the screening.
In good health, as determined by the investigator at Screening procedures, with no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations.
Disqualifiers
Females who are pregnant, planning to become pregnant, or breastfeeding during the trial.
Has a positive result of pregnancy test at Screening or Baseline
History of HIV infection, hepatitis B, hepatitis C or syphilis; positive testing for HIV, hepatitis B, HCV Ab or serological reaction of syphilis
Subjects at risk for tuberculosis (TB).
Trial design
Treatments tested in this trial
- HX15001 (SAD)
- Placebo
- HX15001 (MAD)
- Placebo
Treatment groups
62 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov