Safety, Tolerability and Pharmacokinetics of HSK21542 in Healthy Volunteers
Study Details
Study Description
Brief Summary
This is a first-in-human, Phase I, single-dose escalation clinical trial conducted in Chinese healthy volunteers. The safety, tolerability, and PK of HSK21542 injection in healthy volunteers will be evaluated using a randomized, double-blind, placebo-controlled trial design
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: HSK21542 0.2 μg/kg（15 min) Healthy volunteers 0.2 μg/kg HSK21542 |
Drug: HSK21542
Intravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
|
| Placebo Comparator: HSK21542 0.5 μg/kg Healthy volunteers 0.5 μg/kg HSK21542 or Placebo |
Drug: HSK21542
Intravenous injection 0.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
|
| Placebo Comparator: HSK21542 1 μg/kg （15min) Healthy volunteers 1 μg/kg HSK21542 or Placebo |
Drug: HSK21542
Intravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
|
| Placebo Comparator: HSK21542 1 μg/kg （2min) Healthy volunteers 1 μg/kg HSK21542 or Placebo |
Drug: HSK21542
Intravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min.
Other Names:
|
| Placebo Comparator: HSK21542 0.75 μg/kg Healthy volunteers 0.75 μg/kg HSK21542 or Placebo |
Drug: HSK21542
Intravenous injection 0.75 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
|
| Placebo Comparator: HSK21542 1.5 μg/kg Healthy volunteers 1.5 μg/kg HSK21542 or Placebo |
Drug: HSK21542
Intravenous injection 1.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
|
| Placebo Comparator: HSK21542 2.25 μg/kg Healthy volunteers 2.25 μg/kg HSK21542 or Placebo |
Drug: HSK21542
Intravenous injection 2.25 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
|
| Placebo Comparator: HSK21542 3.375 μg/kg Healthy volunteers 3.375 μg/kg HSK21542 or Placebo |
Drug: HSK21542
Intravenous injection 3.375 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
|
| Placebo Comparator: HSK21542 0.2 μg/kg（2min) Healthy volunteers 0.2 μg/kg HSK21542 or Placebo |
Drug: HSK21542
Intravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- AE/serious AE [From screening up to 4 weeks]
Adverse event/serious adverse event
- Vital signs: Systolic and Diastolic Blood Pressure [From screening up to 4 weeks]
Vital signs (Systolic and Diastolic Blood Pressure) will be collected in healthy volunteers.
Secondary Outcome Measures
- Peak concentration (Cmax) [-30 minutes before administration until 24 hours after administration]
Cmax（a measure of the body's exposure to HSK21542）will be calculated in healthy volunteers.
- Area under the concentration-time curve（AUC） [-30 minutes before administration until 24 hours after administration]
AUC（a measure of the body's exposure to HSK21542）will be calculated in healthy volunteers.
- Tmax [-30 minutes before administration until 24 hours after administration]
time to peak observed
- Total clearance [-30 minutes before administration until 24 hours after administration]
Total clearance
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Males and females aged 18-45 years old (inclusive) at screening;
-
Male volunteers no less than 50 kg, or female volunteers no less than 45 kg, with body mass index [BMI] in the range of 18.0-27.0 kg/m2 (inclusive) at screening;
-
Healthy volunteers, as assessed by the investigator based on past medical history, comprehensive physical examination, vital signs, and specified tests and examinations.
-
Fully understand the nature, purpose, and potential benefits, inconveniences and risks of the trial. Understand the study procedure and voluntarily provide written informed consent.
-
Able to communicate with the investigator and to follow all requirements of the study, and willing to be admitted into the phase I clinical facility.
Exclusion Criteria:
-
Volunteers with a positive urine nicotine test;
-
Volunteers with drug abuse or dependence, or with a positive urine drugs of abuse test;
-
Blood donation or loss of blood > 450 mL within the past 3 months;
-
Participation in any clinical trials within the past 3 months;
-
Volunteers who plan to become pregnant within the next 6 months;
-
Any other factors judged by the investigator to be unsuitable for participating in this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | China |
Sponsors and Collaborators
- Sichuan Haisco Pharmaceutical Group Co., Ltd
- Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
- Study Director: Min Yan, PhD, The Second Affiliated Hospital of Zhejiang University Medical College
- Study Director: Hong-gang Lou, PhD, The Second Affiliated Hospital of Zhejiang University Medical College
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HSK21542-102