A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics of HRS4800 in Healthy Subjects

NCT04991909 | Unknown Phase 1

• 1 other identifier: HRS4800-103
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being conducted to assess the safety and tolerability of HRS4800 after multiple oral administration with different dose regimens in healthy subjects.

Conditions

Pain

Outcome Measures

Primary Outcomes (2)

• Number of the Adverse Events that are related to the treatment from baseline to Day36

  from baseline to Day36

• The severity of the Adverse Events that are related to the treatment from baseline to Day36

  from baseline to Day36

Secondary Outcomes (14)

• Cmax, Peak Concentration;

  Day1

• AUC0-tau, Area under the curve during a dose interval;

  Day1

• Tmax; The time to reach peak concentration;

  Day1

• Css,max, Peak Concentration at steady state;

  Day14

• AUCss, 0-tau, Area under the curve during a dose interval at steady state;

  Day14

Study Arms (2)

Treatment group A

EXPERIMENTAL

Drug: HRS4800

Treatment group B

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HRS4800 DRUG

HRS4800

Treatment group A

Placebo DRUG

Placebo

Treatment group B

Eligibility Criteria

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

You may qualify if:

• Able and willing to provide a written informed consent
• Males and females aged between 18 years and 55 years at screening, inclusive.
• Meet the weight standard
• Agree to take effective contraceptive methods
• No clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests

You may not qualify if:

• Severe infections, injuries or surgeries or plan to undergo any surgeries.
• ALT, AST, ALP or total bilirubin level abnormal
• Estimated Glomerular Filtration Rate (eGFR, using CKD-EPI Creatinine Equation) is abnormal
• 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.
• Subjects with cardiac and Cerebrovascular Disease
• Positive nicotine test
• History of regular alcohol consumption in the past 1 month exceeding an average weekly intake of 21 standard drinks
• Positive drug screening tests
• Positive infectious diseases screening tests
• plan to use of any other medicine during the trial
• Whole blood donation or loss of more than 200 mL of blood within 1 month
• blood transfusion in the past 2 months
• History of allergy to the study drug or any component of it.
• Can't accept assigned meals during the trial
• Treatment with an investigational drug within 30 days (or 5 half-lives, whichever is longer) of dosing.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Design

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

Model Details: HRS4800 Tablet compared with placebo

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: August 5, 2021
• Study Start: August 23, 2021
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: August 31, 2021

Record last verified: 2021-07

Locations

CN (1)