Phase I Clinical Study of Tolerability, Safety and Pharmacokinetics of QHRD106 Injection in Chinese Healthy Subjects With Single and Multiple Doses
Overview
- Phase
- Phase 1
- Intervention
- QHRD106 Injection
- Conditions
- Acute Ischemic Stroke
- Sponsor
- Changzhou Qianhong Bio-pharma Co., Ltd.
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Safety as assessed by incidence, severity, and causality of adverse events
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of QHRD106 in Chinese healthy subjects with single and multiple doses.
Detailed Description
Three dose groups were initially set up. The experimental groups were increased from low to high dose according to the principle of increasing dose, and Urinary kallidinogenase for injection was added as the positive control group. All the selected subjects in the experimental group were given the drug once. Combined with the existing human PK and safety test data, the expected human exposure of the dose group to be increased was still in the range of the lowest safe exposure proved by preclinical toxicology studies, and the safety of the dose to be increased was controllable in humans. The positive control group could be carried out at any time during the single dose increasing stage, and the positive control drug was given once a day for 7 consecutive days.n the stage of multiple dose escalation, QHRD106 injection is intended to be administered in 5600IU, 8400 IU and 12600 IU dosage groups. When the single dose tolerance observation of each dose is completed and the dose escalation termination standard is not reached, the corresponding dose multiple dose escalation study can be selected. Ten subjects in each group were given medicine once a week for 4 consecutive times.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy male or female subjects, male and female equally;
- •Aged between 18 and 50 at the time of screening (including boundary values); Male weight ≥50.0kg, female weight ≥45.0kg; All subjects had a body mass index (BMI) between 19 and 28kg/m2 (including boundary values);
- •Participate voluntarily and sign informed consent to complete the experiment according to the research protocol.
Exclusion Criteria
- •Subjects who meet one of the following conditions will not be enrolled in the trial:
- •a person who is allergic to, or is allergic to, 2 or more drugs or foods, or is known to have a history of allergy to the test preparation and any of its components or related preparations;
- •Patients with a history of clinically serious diseases such as nervous system, blood circulatory system, digestive system, urinary system, respiratory system, immune system, endocrine system, malignant tumor, mental and metabolic abnormalities, or any clinically significant diseases judged by researchers to be in an active period or unstable state;
- •Based on vital signs (including sitting blood pressure, pulse, and body temperature), physical examination, 12-lead electrocardiogram examination, and laboratory examination (including routine blood routine, urine routine, blood biochemistry, and coagulation function), the investigator determined that the abnormality was clinically significant;
- •postural hypotension;
- •α1-antitrypsin deficiency;
- •Patients with difficulty in venous blood collection;
- •People with a history of fainting needles and fainting blood;
- •A history of drug abuse within the last two years (including repeated and heavy use of various narcotic drugs and psychotropic substances for non-medical purposes);
- •Excessive smoking within 3 months before screening (average \> 5 cigarettes/day) or unable to stop using any tobacco products during the test period or smokers within 48 hours before screening;
Arms & Interventions
Part-B MAD in healthy subjects(Cohort 3-5)
A randomized, double-blinded, positive drug and placebo-controlled, multiple ascending dose (MAD) study in healthy male and female subjects. Subjects will receive QHRD106 by intramuscular-injection (im).
Intervention: QHRD106 Injection
Part-C Healthy subjects SAD placebo
A randomized, double-blinded, positive drug and placebo-controlled, single ascending dose (SAD) study in healthy male and female subjects. Subjects will receive placebo by intramuscular-injection (im).
Intervention: placebo
Part-A SAD in healthy subjects(Cohort 1-2)
A randomized, double-blinded, positive drug and placebo-controlled, single ascending dose (SAD) study in healthy male and female subjects. Subjects will receive QHRD106 by intramuscular-injection (im).
Intervention: QHRD106 Injection
Part-D Healthy subjects MAD placebo
A randomized, double-blinded, positive drug and placebo-controlled, single ascending dose (SAD) study in healthy male and female subjects. Subjects will receive placebo by intramuscular-injection (im).
Intervention: placebo
Part-E Healthy subjects MAD positive drug
A randomized, double-blinded, positive drug and placebo-controlled, single ascending dose (SAD) study in healthy male and female subjects. Subjects will receive Human Urinary Kallidinogenase by Intravenous infusion (iv).
Intervention: Human Urinary Kallidinogenase
Outcomes
Primary Outcomes
Safety as assessed by incidence, severity, and causality of adverse events
Time Frame: Up to 43 days after final dose
The frequency and number of adverse events, adverse reactions and serious adverse events in different dose groups and placebo groups were calculated and listed.
Plasma measurements of QHRD106
Time Frame: Up to 43 days after final dose
The concentration of a single dose was measured at 2 different doses, and the concentration of a multiple dose was measured at 3 different doses
Concentration of bradykinin in plasma
Time Frame: Up to 43 days after final dose
The concentration of a single dose was measured at 2 different doses, and the concentration of a multiple dose was measured at 3 different doses