A Trial of HRS4800 Tables in Healthy Male Subjects

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04573036
• Other study ID #: HRS4800-I-101-AUS
• Status: Completed
• Phase: Phase 1
• Start date: November 12, 2020
• Est. completion date: September 20, 2021

Study information

• Verified date: July 2021
• Source: Atridia Pty Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 20, 2021
• Est. primary completion date: September 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• HRS4800 tablets
single oral administration
• Placebo tablets
single oral administration

Locations

Country	Name	City	State
Australia	Linear Clinical Research	Nedlands	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
Atridia Pty Ltd.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1 - HRS4800 Single Dose Escalation - Safety	• 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
Primary	Part 2 - HRS4800 Food Effect	• PK parameters of HRS4800 and its active drug SHR175593 in plasma: AUC0-t	21 days
Primary	Part 2 - HRS4800 Food Effect	• PK parameters of HRS4800 and its active drug SHR175593 in plasma: AUC0-8	21 days
Primary	Part 2 - HRS4800 Food Effect	• PK parameters of HRS4800 and its active drug SHR175593 in plasma: Tmax?	21 days
Primary	Part 2 - HRS4800 Food Effect	• PK parameters of HRS4800 and its active drug SHR175593 in plasma: Cmax	21 days
Primary	Part 2 - HRS4800 Food Effect	• PK parameters of HRS4800 and its active drug SHR175593 in plasma: t1/2?CL/F?Vz/F.	21 days
Secondary	Part 1 - HRS4800 Single Dose Escalation - PK	• PK parameters of HRS4800 and its active drug SHR175593 in plasma: AUC0-t	14 days
Secondary	Part 1 - HRS4800 Single Dose Escalation - PK	AUC0-8?	14 days
Secondary	Part 1 - HRS4800 Single Dose Escalation - PK	Tmax	14 days
Secondary	Part 1 - HRS4800 Single Dose Escalation - PK	Cmax	14 days
Secondary	Part 1 - HRS4800 Single Dose Escalation - PK	t1/2	14 days
Secondary	Part 1 - HRS4800 Single Dose Escalation - PK	CL/F?Vz/F.	14 days