Chronic Pain, Postoperative Pain
Conditions
Keywords
Pain, Postoperative Pain
Brief summary
This is a A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study To Investigate the Safety, Tolerability, and Pharmacokinetics of a kappa receptor agonist HSK21542 in Healthy Volunteers. The study will enroll approximately 50 adults. The anticipated study duration will be up to 6 months.
Interventions
DRUGHSK21542
Single dose, injection, starting dose of 0.2ug escalating up to 20ug
DRUGPlacebo
Single dose, injection matching placebo
Sponsors
Sichuan Haisco Pharmaceutical Group Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female subjects, age 18-45 years; * BMI between 18.0-27.0 kg/m2 * Determined by investigator to be in general good health according to medical history, comprehensive physical examination; * Understanding of the nature, significance, potential benefits and risks of the trial, understanding of the procedures and be able to provide written informed consent voluntarily ; * Good communication with investigators, compliance with the study requirements and willingness to stay in phase I clinical trial ward as required.
Exclusion criteria
* Anyone who has suffered or is currently suffering from any serious diseases, that may interfere with the results of the trial; * Determined by investigator to be abnormal with clinical significance in Physical examination, vital signs monitoring, electrocardiogram, chest radiograph, laboratory examination; * HBsAg positive, HCV antibody positive, Treponema pallidum antibody positive, or HIV antibody positive; * QTcF \> 450ms; * Allergic constitution; * Intolerance of venipuncture and/or history of haemorrhage or needle fainting; * Drug or alcohol abuse; * Have used any prescription, over-the-counter, Chinese herbal medicine or health products within 14 days; * Blood donation or massive bleeding within 3 months (greater than 450 mL); * Participants in any drug clinical trial within 3 months. * Birth planning in the next six months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with adverse events | Between screening and 7-9 days after dosing | To evaluate the safety and tolerability of HSK21542 in comparison with placebo after a single injection in healthy subjects in terms of adverse events |
| Number of subjects with abnormal physical examination/ abnormal vital signs/ abnormal laboratory parameters | Between screening and 7-9 days after dosing | To evaluate the safety and tolerability of HSK21542 in comparison with placebo after a single injection in healthy subjects in terms of abnormal physical examination/ abnormal vital signs/ abnormal laboratory parameters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| t1/2 | From the start of administration to 24 hours after administration | Elimination half-life |
| AUC0-t | From the start of administration to 24 hours after administration | Area under the plasma concentration-time curve from time zero to time t. |
| Cmax | From the start of administration to 24 hours after administration | Maximum (peak) plasma drug concentration |
| CL | From the start of administration to 24 hours after administration | Apparent total body clearance of the drug from plasma |
| Vd | From the start of administration to 24 hours after administration | Apparent volume of distribution |
| AUC0-inf | From the start of administration to 24 hours after administration | Area under the plasma concentration-time curve from time zero to infinity |
| Tmax | From the start of administration to 24 hours after administration | Time to reach maximum (peak) plasma concentration following drug administration |
Countries
Australia
Outcome results
None listed