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
This trial accepts healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
HX15001 (SAD)
DrugPart A (Single Ascending Dose), participants will receive a single intravenous dose of HX15001 at escalating dose levels in sequential cohorts (Cohorts 1-7).
Placebo
DrugParticipants will receive matching placebo across cohorts 1-7 of the study.
HX15001 (MAD)
DrugIn Part B (Multiple Ascending Dose), participants will receive multiple intravenous doses of HX15001 in cohorts 8 and 9 to assess safety, tolerability, and pharmacokinetics.
Placebo
DrugParticipants will receive matching placebo across cohorts 8-9 of the study.
Treatment groups
62 Participants
are divided into 4 treatment groupsGroup A: Part A - Single-Ascending Dose (SAD)Experimental treatment 1 intervention
Group B: Placebo SAD Cohorts (1-7)Placebo comparator 1 intervention
Group C: Part B - Multiple Ascending Dose (MAD)Experimental treatment 1 intervention
Group D: Placebo MAD Cohorts (8-9)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Adverse Events (AEs) and Serious Adverse Events (SAEs) cohort 1-3
Incidence, severity, and causal relationship of Serious Adverse Events (SAEs) including changes in laboratory parameters (Hematology, Chemistry panels, Coagulation and Urinalysis); 12-lead ECGs parameters; Vital signs (Blood pressure, heart rate, respiratory rate and body temperature)
Time frame
Up to day 1132
Adverse Events (AEs) and Serious Adverse Events (SAEs) cohort 4-7
Incidence, severity, and causal relationship of Serious Adverse Events (SAEs) including changes in laboratory parameters (Hematology, Chemistry panels, Coagulation and Urinalysis); 12-lead ECGs parameters; Vital signs (Blood pressure, heart rate, respiratory rate and body temperature)
Time frame
Up to day 1413
Adverse Events (AEs) and Serious Adverse Events (SAEs) cohort 8-9
Incidence, severity, and causal relationship of Serious Adverse Events (SAEs) including changes in laboratory parameters (Hematology, Chemistry panels, Coagulation and Urinalysis); 12-lead ECGs parameters; Vital signs (Blood pressure, heart rate, respiratory rate and body temperature)
Time frame
Up to day 183Secondary outcomes
1
Cmax
Maximum concentration after single and multiple ascending doses
Time frame
Up to day 113 (cohort 1-3) Up to day 141 (Cohort 4-7) Up to day 183 (Cohort 8-9)2
Tmax
Time to reach maximum concentration after single and multiple ascending doses
Time frame
Up to day 113 (cohort 1-3) Up to day 141 (Cohort 4-7) Up to day 183 (Cohort 8-9)3
t1/2
Half life after single and multiple ascending doses
Time frame
Up to day 113 (cohort 1-3) Up to day 141 (Cohort 4-7) Up to day 183 (Cohort 8-9)4
AUC
Area under the curve after single and multiple ascending doses
Time frame
Up to day 113 (cohort 1-3) Up to day 141 (Cohort 4-7) Up to day 183 (Cohort 8-9)Sponsors and contacts
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Source ClinicalTrials.gov