A Trial to Evaluate the Safety and PK Profile of HRS4800 in Healthy Subjects

NCT04862884 | Unknown Phase 1

• 1 other identifier: HRS4800-101
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study will be conducted to evaluate the safety and PK profile of HRS4800 tablets after single oral administration in different dose levels compared to placebo.

Conditions

Pain

Outcome Measures

Primary Outcomes (4)

• Proportion of Participants with Adverse Events (AEs)

  1-21 days

• Proportion of Participants with Hematology, Clinical Chemistry, Urinalysis Laboratory Abnormalities

  1-21 days

• Proportion of Participants with 12-lead electrocardiograms (ECG) Abnormalities

  1-21 days

• Proportion of Participants with Vital Sign and Physical Examinations Abnormalities

  1-21 days

Secondary Outcomes (9)

• Maximum Observed Plasma Concentration (Cmax) of HRS4800,

  1-6 days

• Time to Attain Maximum Observed Plasma Concentration (Tmax) of HRS4800,

  1-6 days

• Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC[last]) of HRS4800,

  1-6 days

• Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of HRS4800

  1-6 days

• Apparent Terminal Elimination Half-Life (t1/2) of HRS4800,

  1-6 days

Study Arms (2)

HRS4800 tablets

EXPERIMENTAL

Drug: HRS4800 tablets

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

HRS4800 tablets DRUG

1. Drug: HRS4800 tablets Low-dose group, single oral administration 2. Drug: HRS4800 tablets Low-medium dose group, single oral administration 3. Drug: HRS4800 tablets medium -dose group, single oral administration 4. Drug: HRS4800 tablets Medium and high dose group, single oral administration 5. Drug: HRS4800 tablets High-dose group, single oral administration

HRS4800 tablets

placebo DRUG

1. Drug: placebo Low-dose group, single oral administration 2. Drug: placebo Low-medium dose group, single oral administration 3. Drug: placebo medium -dose group, single oral administration 4. Drug: placebo Medium and high dose group, single oral administration 5. Drug: placebo High-dose group, single oral administration

placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 19.0 and 26.0 kg/m2, inclusive.
• Agree to take contraceptive measures and promise not to donate sperm since signing the informed consent form, to 3 months after the administration.
• 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.

You may not qualify if:

• History of severe digestive system disease or having a digestive disease currently within 3 months 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.
• ALT, AST, ALP or total bilirubin level exceeds the upper limit of normal (ULN) during screening/baseline visits.
• Subject's supine systolic BP is ≥140 mmHg or \<90 mmHg; diastolic BP ≥90 mmHg or \<60 mmHg at screening or before first dosing.
• Positive breath alcohol test after confirmation in a repeat test during screening/baseline visits.
• Positive drug screening tests,.
• 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 received blood within 2 months prior to dosing.
• History of allergy to the study drug or any component of it.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

li Yue

CONTACT

86-021-61623632; li.yue@hengrui.com

Miaoyan Chen

CONTACT

86- 021-61623632; Miaoyan.chen@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: HRS4800 tablets single administration in healthy male

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 28, 2021
• Study Start: May 3, 2021
• Primary Completion: September 3, 2021
• Study Completion: September 24, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04