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

Phase 1

Completed

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

• Registration Number: NCT05829551
• Lead Sponsor: Guangdong Raynovent Biotech Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-20
• Primary Completion: 2022-08-12
• Study Completion: 2022-08-12
• Status Verified: 2023-04
• Study First Submitted: 2023-04-03
• Study First Submitted QC: 2023-04-13
• Last Update Submitted: 2023-04-13
• Study First Posted: 2023-04-25
• Last Update Posted: 2023-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RAY1216 dose 1	RAY1216 dose 1	SAD
RAY1216 dose 3	RAY1216 dose 3	SAD
RAY1216 dose 9（food effect）	RAY1216 dose 9	food effect on single dose
RAY1216 dose 2	RAY1216 dose 2	SAD
RAY1216 dose 8	RAY1216 dose 8	MAD
RAY1216 dose 4（DDI）	RAY1216 dose 4 &ritonavir	drug-drug interaction
RAY1216 dose 5	RAY1216 dose 5	MAD
RAY1216 dose 6	RAY1216 dose 6	MAD
RAY1216 dose 7	RAY1216 dose 7	MAD
RAY1216 dose 10（food effect）	RAY1216 dose 10	food effect on single dose

Primary Outcome Measures

Name	Time	Method
Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE) in single ascending dose	Day 1 to Day 5	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	Day 1 to Day 9	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	Day 1 to Day 21	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	Day 1 to Day 15	A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The First Hospital of Jilin University; 🇨🇳 Jilin, China