Clinical trial NCT04862884: A Trial to Evaluate the Safety and PK Profile of HRS4800 in Healthy Subjects
Official title: A Phase 1, Single Center, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, on the Pharmacokinetics of HRS4800 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pain
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-04-28
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: HRS4800 tablets single administration in healthy male
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Male aged between 18 years and 55 years at screening, inclusive.
3. Total body weight ≥50 kg at screening, and body mass index (BMI) between 19.0 and 26.0 kg/m2, inclusive.
4. Agree to take contraceptive measures and promise not to donate sperm since signing the informed consent form, to 3 months after the administration.
5. 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.

Exclusion Criteria:

1. 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.
2. Severe infections, injuries or surgeries within 3 months of screening or before first dosing, or plan to undergo any surgeries during the trial.
3. ALT, AST, ALP or total bilirubin level exceeds the upper limit of normal (ULN) during screening/baseline visits.
4. Subject's supine systolic BP is ≥140 mmHg or \<90 mmHg; diastolic BP ≥90 mmHg or \<60 mmHg at screening or before first dosing.
5. Positive breath alcohol test after confirmation in a repeat test during screening/baseline visits.
6. Positive drug screening tests,.
7. 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.
8. History of allergy to the study drug or any component of it.

Primary outcomes:
measure: Proportion of Participants with Adverse Events (AEs)
timeFrame: 1-21 days
measure: Proportion of Participants with Hematology, Clinical Chemistry, Urinalysis Laboratory Abnormalities
timeFrame: 1-21 days
measure: Proportion of Participants with 12-lead electrocardiograms (ECG) Abnormalities
timeFrame: 1-21 days
measure: Proportion of Participants with Vital Sign and Physical Examinations Abnormalities
timeFrame: 1-21 days
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of HRS4800,
timeFrame: 1-6 days
measure: Time to Attain Maximum Observed Plasma Concentration (Tmax) of HRS4800,
timeFrame: 1-6 days
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC[last]) of HRS4800,
timeFrame: 1-6 days
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of HRS4800
timeFrame: 1-6 days
measure: Apparent Terminal Elimination Half-Life (t1/2) of HRS4800,
timeFrame: 1-6 days
measure: Elimination Rate Constant (λz, or kel) of HRS4800,
timeFrame: 1-6 days
measure: Apparent Volume of Distribution (VZ/F) During Terminal Phase of HRS4800
timeFrame: 1-6 days
measure: Total HRS4800 of Cumulative Amount Excreted in Urine (Aeu)
timeFrame: 1-6 days
measure: Total HRS4800 of Fraction of Dose Excreted in Urine (feu)
timeFrame: 1-6 days
Other outcomes:
Locations:
Study officials:
References: