The Safety, Tolerability and Pharmacokinetics Study of RAY1216 in Healthy Adult Participants

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics of RAY1216 and the Effect of Food on RAY1216 Pharmacokinetics in Healthy Adult Participants

This is double-blind,randomized, single and multiple dose trial to evaluate the pharmacokinetics(PK), safety, tolerability and drug-drug interaction of RAY1216, and the effect of food on RAY1216 Pharmacokinetics.

Study Overview

• Status: Completed
• Conditions: COVID-19 (Coronavirus Disease 2019)
• Intervention / Treatment: Drug: RAY1216 dose 1; Drug: RAY1216 dose 2; Drug: RAY1216 dose 3; Drug: RAY1216 dose 4 &ritonavir; Drug: RAY1216 dose 5; Drug: RAY1216 dose 6; Drug: RAY1216 dose 7; Drug: RAY1216 dose 8; Drug: RAY1216 dose 9; Drug: RAY1216 dose 10

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jilin, China
    • The First Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Signature of a dated Informed Consent Form (ICF) indicating that the subject has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment.
2. Subjects must be willing and able to adhere to the visit schedule and protocol requirements and be available to complete the study.
3. Subjects (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product.
4. Males and female subjects between 18-50 years (Both inclusive). Body weight is no less than 50 kg in males and no less than 45 kg in females. Body mass index (BMI) 18≤BMI≤28 kg/m2; BMI is determined by the following equation: BMI = weight/height2 (kg/m2).
5. Physical condition and vital signs: Normal or abnormality has no clinical significance.

Exclusion Criteria:

1. Known hypersensitivity and/or allergy to some drugs and food, especially for the composition that is similar to the investigative product;
2. The average daily smoking are more than 5 cigarettes within 3 months prior to screening.
3. Known history of drug or alcohol abuse.(defined as consumption of 14 units of alcohol per week: 1 unit = 285 ml of beer; or the equivalent of 25 ml of spirit, or 100 ml of wine )
4. Subjects who donated blood or bleeding profusely (> 400 mL) in the 3 months preceding study screening.
5. Dysphagia or any medical history in gastrointestinal that interferes with the absorption of drugs, include a history of frequent nausea or vomit causes by any etiology.
6. History or presence of any disease or condition known to increase the risk of bleeding , eg. acute gastritis, duodenal ulcer, etc.
7. Participated in another clinical research study and received any investigational products within 3 months prior to dosing.
8. History of having any special food (including dragon fruit, mango, grapefruit, etc.), strenuous exercises, or other factors may interfere with the absorption, distribution, metabolism, or excretion of drug within 7 days prior to screening.
9. Inability to consume the food provided in the study ( a high fat diet).This requirement only applies to subjects under fed condition.
10. Presence of clinically significant abnormalities in ECG or QTcF>450ms
11. Subjects who may not complete the study for other reasons or should not be included in the study in the opinion of the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RAY1216 dose 1; SAD	Drug: RAY1216 dose 1; RAY1216 dose 1 or Placebo
Experimental: RAY1216 dose 2; SAD	Drug: RAY1216 dose 2; RAY1216 dose 2 or Placebo
Experimental: RAY1216 dose 3; SAD	Drug: RAY1216 dose 3; RAY1216 dose 3 or Placebo
Experimental: RAY1216 dose 4（DDI）; drug-drug interaction	Drug: RAY1216 dose 4 &ritonavir; RAY1216 dose 4 &ritonavir or Placebo
Experimental: RAY1216 dose 5; MAD	Drug: RAY1216 dose 5; RAY1216 dose 5 or Placebo
Experimental: RAY1216 dose 6; MAD	Drug: RAY1216 dose 6; RAY1216 dose 6 or Placebo
Experimental: RAY1216 dose 7; MAD	Drug: RAY1216 dose 7; RAY1216 dose 7 or Placebo
Experimental: RAY1216 dose 8; MAD	Drug: RAY1216 dose 8; RAY1216 dose 8 or Placebo
Experimental: RAY1216 dose 9（food effect）; food effect on single dose	Drug: RAY1216 dose 9; RAY1216 dose 9 or Placebo with high fat meal
Experimental: RAY1216 dose 10（food effect）; food effect on single dose	Drug: RAY1216 dose 10; RAY1216 dose 10 or Placebo with high fat meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE) in single ascending dose	A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported	Day 1 to Day 5
Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE) in multiple ascending dose	A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported	Day 1 to Day 9
Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE) in DDI part	A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported	Day 1 to Day 15
Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE) in food effect part	A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported	Day 1 to Day 21

Secondary Outcome Measures

Outcome Measure	Time Frame
To determine the effect of food on the PK of RAY1216 single dose(Cmax)	Day 1 to Day 21
To investigate the effect of Ritonavir on the pharmacokinetics of RAY1216(Cmax)	Day 1 to Day 15
To determine the single and multiple oral dose pharmacokinetic profiles of RAY1216(Cmax)	Day 1 to Day 9
To determine the effect of food on the PK of RAY1216 single dose(AUC0-∞)	Day 1 to Day 21
To investigate the effect of Ritonavir on the pharmacokinetics of RAY1216(AUC0-∞)	Day 1 to Day 15
To determine the single and multiple oral dose pharmacokinetic profiles of RAY1216(Cmin)	Day 1 to Day 9

Collaborators and Investigators

• Sponsor: Guangdong Raynovent Biotech Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2022
• Primary Completion (Actual): August 12, 2022
• Study Completion (Actual): August 12, 2022

Study Registration Dates

• First Submitted: April 3, 2023
• First Submitted That Met QC Criteria: April 13, 2023
• First Posted (Actual): April 25, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Ritonavir
• Other Study ID Numbers: RAY1216-22-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No