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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04573036




Registration number
NCT04573036
Ethics application status
Date submitted
16/09/2020
Date registered
5/10/2020
Date last updated
31/03/2022

Titles & IDs
Public title
A Trial of HRS4800 Tables in Healthy Male Subjects
Scientific 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
Secondary ID [1] 0 0
HRS4800-I-101-AUS
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HRS4800 tablets
Treatment: Drugs - Placebo tablets

Experimental: HRS4800 tablets cohort 1 - Part 1 - HRS4800 Single Ascending Dose

Experimental: HRS4800 tablets cohort 2 - Part 1 - HRS4800 Single Ascending Dose

Experimental: HRS4800 tablets cohort 3 - Part 1 - HRS4800 Single Ascending Dose

Experimental: HRS4800 tablets cohort 4 - Part 1 - HRS4800 Single Ascending Dose

Experimental: HRS4800 tablets cohort 5 - Part 2 - HRS4800 Food Effect

Placebo Comparator: Placebo tablets -


Treatment: Drugs: HRS4800 tablets
single oral administration

Treatment: Drugs: Placebo tablets
single oral administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1 - HRS4800 Single Dose Escalation - Safety
Timepoint [1] 0 0
14 days
Primary outcome [2] 0 0
Part 2 - HRS4800 Food Effect
Timepoint [2] 0 0
21 days
Primary outcome [3] 0 0
Part 2 - HRS4800 Food Effect
Timepoint [3] 0 0
21 days
Primary outcome [4] 0 0
Part 2 - HRS4800 Food Effect
Timepoint [4] 0 0
21 days
Primary outcome [5] 0 0
Part 2 - HRS4800 Food Effect
Timepoint [5] 0 0
21 days
Primary outcome [6] 0 0
Part 2 - HRS4800 Food Effect
Timepoint [6] 0 0
21 days
Secondary outcome [1] 0 0
Part 1 - HRS4800 Single Dose Escalation - PK
Timepoint [1] 0 0
14 days
Secondary outcome [2] 0 0
Part 1 - HRS4800 Single Dose Escalation - PK
Timepoint [2] 0 0
14 days
Secondary outcome [3] 0 0
Part 1 - HRS4800 Single Dose Escalation - PK
Timepoint [3] 0 0
14 days
Secondary outcome [4] 0 0
Part 1 - HRS4800 Single Dose Escalation - PK
Timepoint [4] 0 0
14 days
Secondary outcome [5] 0 0
Part 1 - HRS4800 Single Dose Escalation - PK
Timepoint [5] 0 0
14 days
Secondary outcome [6] 0 0
Part 1 - HRS4800 Single Dose Escalation - PK
Timepoint [6] 0 0
14 days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/09/2021
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
- Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Atridia Pty Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04573036
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Na Li
Address 0 0
Jiangsu Hengrui Pharmaceuticals Co.,Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04573036