- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04573036
A Trial of HRS4800 Tables in Healthy Male Subjects
March 28, 2022 updated by: Atridia Pty Ltd.
A Phase 1, Single Center, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and the Effect of Food on the Pharmacokinetics of HRS4800 in Healthy Male Participants
This is a single-site study to evaluate the safety, tolerability and pharmacokinetics (PK) of single dose administration of HRS4800, and the effect of food on the PK of HRS4800 in healthy male subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Western Australia
-
Nedlands, Western Australia, Australia
- Linear Clinical Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Able to understand the purposes and risks of the trial and comply with all study procedures before entering the trial, and provide signed informed consent.
- Male aged between 18 years and 55 years at screening, inclusive.
- Total body weight ≥50 kg at screening, and body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive.
- Agree to practice true abstinence; be surgically sterilised (performed at least 6 months prior and documented to no longer produce sperm - verbal confirmation through medical history review acceptable); or agree to use a condom if sexually active with a female partner of childbearing potential for at least 3 months after dosing.
- No clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests (hematology, urinalysis, blood chemistry, coagulation function), and ECG, as determined by the investigator. Male aged between 18 years and 55 years at screening, inclusive.
Exclusion Criteria:
- History of severe digestive system disease or having a digestive disease currently within a month of screening or before first dosing, and may affect drug absorption or have safety risks.
- Severe infections, injuries or surgeries within 3 months of screening or before first dosing, or plan to undergo any surgeries during the trial.
- Use of any medicine affecting liver metabolism within 1 month of screening (see Appendix 1); use of any prescription medications within 14 days or 5 half-lives prior to dosing, use of any over-the-counter medicine or herbal products within 7 days prior to dosing; intention to use any other medicine during the trial.
- Whole blood donation or loss of more than 200 mL of blood within 1 month prior to dosing; or blood donation or loss of more than 400 mL of blood within 3 months prior to dosing; or plasma donation within 14 days prior to dosing; or received blood within 8 weeks prior to dosing.
- History of allergy to the study drug or any component of it.
- History of regular alcohol consumption in the past 1 month exceeding an average weekly intake of 21 standard drinks: 1 drink=5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor).
- Subject has used more than 5 tobacco or nicotine-containing products per day in the 6 months prior to dosing and is unable to refrain from use of such products from at least 48 hours prior to check-in through to the final study visit.
- Treatment with an investigational drug within 30 days (or 5 half-lives, whichever is longer) of dosing.
- History of drug abuse within 2 years prior to screening.
- Other conditions or laboratory abnormality that may increase the risk associated with study participation or IP administration or interfere with the interpretation of study results and, at the discretion of the investigator, makes the subject inappropriate for entry into this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo tablets
|
single oral administration
|
Experimental: HRS4800 tablets cohort 1
Part 1 - HRS4800 Single Ascending Dose
|
single oral administration
|
Experimental: HRS4800 tablets cohort 2
Part 1 - HRS4800 Single Ascending Dose
|
single oral administration
|
Experimental: HRS4800 tablets cohort 3
Part 1 - HRS4800 Single Ascending Dose
|
single oral administration
|
Experimental: HRS4800 tablets cohort 4
Part 1 - HRS4800 Single Ascending Dose
|
single oral administration
|
Experimental: HRS4800 tablets cohort 5
Part 2 - HRS4800 Food Effect
|
single oral administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Part 1 - HRS4800 Single Dose Escalation - Safety
Time Frame: 14 days
|
• Safety: Incidence and severity of adverse events (AEs), vital signs (pulse rate, respiratory rate, blood pressure, body temperature), physical examination, laboratory tests, electrocardiogram (ECG), etc.
|
14 days
|
Part 2 - HRS4800 Food Effect
Time Frame: 21 days
|
• PK parameters of HRS4800 and its active drug SHR175593 in plasma: AUC0-t
|
21 days
|
Part 2 - HRS4800 Food Effect
Time Frame: 21 days
|
• PK parameters of HRS4800 and its active drug SHR175593 in plasma: AUC0-∞
|
21 days
|
Part 2 - HRS4800 Food Effect
Time Frame: 21 days
|
• PK parameters of HRS4800 and its active drug SHR175593 in plasma: Tmax、
|
21 days
|
Part 2 - HRS4800 Food Effect
Time Frame: 21 days
|
• PK parameters of HRS4800 and its active drug SHR175593 in plasma: Cmax
|
21 days
|
Part 2 - HRS4800 Food Effect
Time Frame: 21 days
|
• PK parameters of HRS4800 and its active drug SHR175593 in plasma: t1/2、CL/F、Vz/F.
|
21 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Part 1 - HRS4800 Single Dose Escalation - PK
Time Frame: 14 days
|
• PK parameters of HRS4800 and its active drug SHR175593 in plasma: AUC0-t
|
14 days
|
Part 1 - HRS4800 Single Dose Escalation - PK
Time Frame: 14 days
|
AUC0-∞、
|
14 days
|
Part 1 - HRS4800 Single Dose Escalation - PK
Time Frame: 14 days
|
Tmax
|
14 days
|
Part 1 - HRS4800 Single Dose Escalation - PK
Time Frame: 14 days
|
Cmax
|
14 days
|
Part 1 - HRS4800 Single Dose Escalation - PK
Time Frame: 14 days
|
t1/2
|
14 days
|
Part 1 - HRS4800 Single Dose Escalation - PK
Time Frame: 14 days
|
CL/F、Vz/F.
|
14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Na Li, Jiangsu Hengrui Pharmaceuticals Co.,Ltd
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 12, 2020
Primary Completion (Actual)
September 20, 2021
Study Completion (Actual)
September 20, 2021
Study Registration Dates
First Submitted
September 16, 2020
First Submitted That Met QC Criteria
September 27, 2020
First Posted (Actual)
October 5, 2020
Study Record Updates
Last Update Posted (Actual)
March 31, 2022
Last Update Submitted That Met QC Criteria
March 28, 2022
Last Verified
July 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- HRS4800-I-101-AUS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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