A Phase I Clinical Trial Evaluating the Safety, Tolerability and Pharmacokinetics of AAPB for Injection

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorJiangsu Kanion Pharmaceutical Co., Ltd

About this trial

This is a Phase I clinical to evaluate the safety and tolerability of single and multiple intravenous infusions of AAPB at different doses over 7 consecutive days.

Eligibility criteria

Qualifiers

Healthy subjects, aged between 18 and 45 (both ends included), both male and female;

When screening patients, male weight ≥50kg, female weight ≥45kg, body mass index (BMI) in the range of 19-28 kg/m² (including the upper and lower limits), BMI= weight (kg)/height (m) ²;

Able to communicate well with researchers, willing and able to comply with the lifestyle restrictions specified in the program;

Women or men of reproductive age who agree to use investigatorial-approved contraceptive methods (such as Iuds, condoms, spermicide gel plus condoms, diaphragms, etc.) throughout the trial period;

Disqualifiers

The investigator determines that the subject has a history of present disease and past disease or dysfunction affecting the clinical trial, including but not limited to diseases of the nervous system, cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, metabolic disease, rheumatic disease, blood system, etc.;

Suffers from mental illness or has a history of mental illness;

Have a history of malignant tumors or other diseases that are not suitable for clinical trials;

History of cardiovascular disease (such as heart dysfunction, coronary artery disease, cardiomyopathy, valvular heart disease, family history of congenital long QT syndrome, family history of sudden death, etc.) or ECG results showing QTcF > 450ms, or clinically significant conduction block or T wave changes;

Trial design

Treatments tested in this trial

  • Single dose, AAPB by injection, intravenous drip.
  • Single dose, placebo, intravenous drip.
  • Multiple dosing, AAPB for injection, intravenous drip
  • Multiple dosing, placebo, IV drip

Treatment groups

56 Participants
are divided into 14 treatment groups

14

Treatment groups

See each treatment group below.