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

Primary Purpose

COVID-19 (Coronavirus Disease 2019)

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
RAY1216 dose 1
RAY1216 dose 2
RAY1216 dose 3
RAY1216 dose 4 &ritonavir
RAY1216 dose 5
RAY1216 dose 6
RAY1216 dose 7
RAY1216 dose 8
RAY1216 dose 9
RAY1216 dose 10
Sponsored by
Guangdong Raynovent Biotech Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 (Coronavirus Disease 2019)

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Subjects must be willing and able to adhere to the visit schedule and protocol requirements and be available to complete the study. Subjects (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product. 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). Physical condition and vital signs: Normal or abnormality has no clinical significance. Exclusion Criteria: Known hypersensitivity and/or allergy to some drugs and food, especially for the composition that is similar to the investigative product; The average daily smoking are more than 5 cigarettes within 3 months prior to screening. 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 ) Subjects who donated blood or bleeding profusely (> 400 mL) in the 3 months preceding study screening. 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. History or presence of any disease or condition known to increase the risk of bleeding , eg. acute gastritis, duodenal ulcer, etc. Participated in another clinical research study and received any investigational products within 3 months prior to dosing. 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. Inability to consume the food provided in the study ( a high fat diet).This requirement only applies to subjects under fed condition. Presence of clinically significant abnormalities in ECG or QTcF>450ms Subjects who may not complete the study for other reasons or should not be included in the study in the opinion of the investigator.

Sites / Locations

  • The First Hospital of Jilin University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

RAY1216 dose 1

RAY1216 dose 2

RAY1216 dose 3

RAY1216 dose 4(DDI)

RAY1216 dose 5

RAY1216 dose 6

RAY1216 dose 7

RAY1216 dose 8

RAY1216 dose 9(food effect)

RAY1216 dose 10(food effect)

Arm Description

SAD

SAD

SAD

drug-drug interaction

MAD

MAD

MAD

MAD

food effect on single dose

food effect on single dose

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

To determine the effect of food on the PK of RAY1216 single dose(Cmax)
To investigate the effect of Ritonavir on the pharmacokinetics of RAY1216(Cmax)
To determine the single and multiple oral dose pharmacokinetic profiles of RAY1216(Cmax)
To determine the effect of food on the PK of RAY1216 single dose(AUC0-∞)
To investigate the effect of Ritonavir on the pharmacokinetics of RAY1216(AUC0-∞)
To determine the single and multiple oral dose pharmacokinetic profiles of RAY1216(Cmin)

Full Information

First Posted
April 3, 2023
Last Updated
April 13, 2023
Sponsor
Guangdong Raynovent Biotech Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05829551
Brief Title
The Safety, Tolerability and Pharmacokinetics Study of RAY1216 in Healthy Adult Participants
Official Title
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics of RAY1216 and the Effect of Food on RAY1216 Pharmacokinetics in Healthy Adult Participants
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 20, 2022 (Actual)
Primary Completion Date
August 12, 2022 (Actual)
Study Completion Date
August 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangdong Raynovent Biotech Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 (Coronavirus Disease 2019)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RAY1216 dose 1
Arm Type
Experimental
Arm Description
SAD
Arm Title
RAY1216 dose 2
Arm Type
Experimental
Arm Description
SAD
Arm Title
RAY1216 dose 3
Arm Type
Experimental
Arm Description
SAD
Arm Title
RAY1216 dose 4(DDI)
Arm Type
Experimental
Arm Description
drug-drug interaction
Arm Title
RAY1216 dose 5
Arm Type
Experimental
Arm Description
MAD
Arm Title
RAY1216 dose 6
Arm Type
Experimental
Arm Description
MAD
Arm Title
RAY1216 dose 7
Arm Type
Experimental
Arm Description
MAD
Arm Title
RAY1216 dose 8
Arm Type
Experimental
Arm Description
MAD
Arm Title
RAY1216 dose 9(food effect)
Arm Type
Experimental
Arm Description
food effect on single dose
Arm Title
RAY1216 dose 10(food effect)
Arm Type
Experimental
Arm Description
food effect on single dose
Intervention Type
Drug
Intervention Name(s)
RAY1216 dose 1
Intervention Description
RAY1216 dose 1 or Placebo
Intervention Type
Drug
Intervention Name(s)
RAY1216 dose 2
Intervention Description
RAY1216 dose 2 or Placebo
Intervention Type
Drug
Intervention Name(s)
RAY1216 dose 3
Intervention Description
RAY1216 dose 3 or Placebo
Intervention Type
Drug
Intervention Name(s)
RAY1216 dose 4 &ritonavir
Intervention Description
RAY1216 dose 4 &ritonavir or Placebo
Intervention Type
Drug
Intervention Name(s)
RAY1216 dose 5
Intervention Description
RAY1216 dose 5 or Placebo
Intervention Type
Drug
Intervention Name(s)
RAY1216 dose 6
Intervention Description
RAY1216 dose 6 or Placebo
Intervention Type
Drug
Intervention Name(s)
RAY1216 dose 7
Intervention Description
RAY1216 dose 7 or Placebo
Intervention Type
Drug
Intervention Name(s)
RAY1216 dose 8
Intervention Description
RAY1216 dose 8 or Placebo
Intervention Type
Drug
Intervention Name(s)
RAY1216 dose 9
Intervention Description
RAY1216 dose 9 or Placebo with high fat meal
Intervention Type
Drug
Intervention Name(s)
RAY1216 dose 10
Intervention Description
RAY1216 dose 10 or Placebo with high fat meal
Primary Outcome Measure Information:
Title
Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE) in single ascending dose
Description
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported
Time Frame
Day 1 to Day 5
Title
Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE) in multiple ascending dose
Description
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported
Time Frame
Day 1 to Day 9
Title
Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE) in DDI part
Description
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported
Time Frame
Day 1 to Day 15
Title
Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE) in food effect part
Description
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported
Time Frame
Day 1 to Day 21
Secondary Outcome Measure Information:
Title
To determine the effect of food on the PK of RAY1216 single dose(Cmax)
Time Frame
Day 1 to Day 21
Title
To investigate the effect of Ritonavir on the pharmacokinetics of RAY1216(Cmax)
Time Frame
Day 1 to Day 15
Title
To determine the single and multiple oral dose pharmacokinetic profiles of RAY1216(Cmax)
Time Frame
Day 1 to Day 9
Title
To determine the effect of food on the PK of RAY1216 single dose(AUC0-∞)
Time Frame
Day 1 to Day 21
Title
To investigate the effect of Ritonavir on the pharmacokinetics of RAY1216(AUC0-∞)
Time Frame
Day 1 to Day 15
Title
To determine the single and multiple oral dose pharmacokinetic profiles of RAY1216(Cmin)
Time Frame
Day 1 to Day 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Subjects must be willing and able to adhere to the visit schedule and protocol requirements and be available to complete the study. Subjects (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product. 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). Physical condition and vital signs: Normal or abnormality has no clinical significance. Exclusion Criteria: Known hypersensitivity and/or allergy to some drugs and food, especially for the composition that is similar to the investigative product; The average daily smoking are more than 5 cigarettes within 3 months prior to screening. 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 ) Subjects who donated blood or bleeding profusely (> 400 mL) in the 3 months preceding study screening. 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. History or presence of any disease or condition known to increase the risk of bleeding , eg. acute gastritis, duodenal ulcer, etc. Participated in another clinical research study and received any investigational products within 3 months prior to dosing. 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. Inability to consume the food provided in the study ( a high fat diet).This requirement only applies to subjects under fed condition. Presence of clinically significant abnormalities in ECG or QTcF>450ms Subjects who may not complete the study for other reasons or should not be included in the study in the opinion of the investigator.
Facility Information:
Facility Name
The First Hospital of Jilin University
City
Jilin
Country
China

12. IPD Sharing Statement

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

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