A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics of HRS4800 in Healthy Subjects
NCT ID: NCT04991909
Last Updated: 2021-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1
96 participants
INTERVENTIONAL
2021-08-23
2022-05-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment group A
HRS4800
HRS4800
Treatment group B
Placebo
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HRS4800
HRS4800
Placebo
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Males and females aged between 18 years and 55 years at screening, inclusive.
3. Meet the weight standard
4. Agree to take effective contraceptive methods
5. No clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests
Exclusion Criteria
2. ALT, AST, ALP or total bilirubin level abnormal
3. Estimated Glomerular Filtration Rate (eGFR, using CKD-EPI Creatinine Equation) is abnormal
4. Subject's supine systolic BP is \>140 mmHg or \<90 mmHg; diastolic BP \>90 mmHg or \<40 mmHg at screening/baseline visits or before dosing.
5. Subjects with cardiac and Cerebrovascular Disease
6. Positive nicotine test
7. History of regular alcohol consumption in the past 1 month exceeding an average weekly intake of 21 standard drinks
8. Positive drug screening tests
9. Positive infectious diseases screening tests
10. plan to use of any other medicine during the trial
11. Whole blood donation or loss of more than 200 mL of blood within 1 month
12. blood transfusion in the past 2 months
13. History of allergy to the study drug or any component of it.
14. Can't accept assigned meals during the trial
15. Treatment with an investigational drug within 30 days (or 5 half-lives, whichever is longer) of dosing.
16. poor tolerance or difficult for vein blood collection
17. Other conditions or laboratory abnormality that may increase the risk associated with study participation
18 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HRS4800-103
Identifier Type: -
Identifier Source: org_study_id