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

NCT05829551 | Completed Phase 1

• 1 other identifier: RAY1216-22-01
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 (Coronavirus Disease 2019)

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• 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

Study Arms (10)

RAY1216 dose 1

EXPERIMENTAL

SAD

Drug: RAY1216 dose 1

RAY1216 dose 2

EXPERIMENTAL

SAD

Drug: RAY1216 dose 2

RAY1216 dose 3

EXPERIMENTAL

SAD

Drug: RAY1216 dose 3

RAY1216 dose 4（DDI）

EXPERIMENTAL

drug-drug interaction

Drug: RAY1216 dose 4 &ritonavir

RAY1216 dose 5

EXPERIMENTAL

MAD

Drug: RAY1216 dose 5

RAY1216 dose 6

EXPERIMENTAL

MAD

Drug: RAY1216 dose 6

RAY1216 dose 7

EXPERIMENTAL

MAD

Drug: RAY1216 dose 7

RAY1216 dose 8

EXPERIMENTAL

MAD

Drug: RAY1216 dose 8

RAY1216 dose 9（food effect）

EXPERIMENTAL

food effect on single dose

Drug: RAY1216 dose 9

RAY1216 dose 10（food effect）

EXPERIMENTAL

food effect on single dose

Drug: RAY1216 dose 10

Interventions

RAY1216 dose 1 DRUG

RAY1216 dose 1 or Placebo

RAY1216 dose 1

RAY1216 dose 2 DRUG

RAY1216 dose 2 or Placebo

RAY1216 dose 2

RAY1216 dose 3 DRUG

RAY1216 dose 3 or Placebo

RAY1216 dose 3

RAY1216 dose 4 &ritonavir DRUG

RAY1216 dose 4 \&ritonavir or Placebo

RAY1216 dose 4（DDI）

RAY1216 dose 5 DRUG

RAY1216 dose 5 or Placebo

RAY1216 dose 5

RAY1216 dose 6 DRUG

RAY1216 dose 6 or Placebo

RAY1216 dose 6

RAY1216 dose 7 DRUG

RAY1216 dose 7 or Placebo

RAY1216 dose 7

RAY1216 dose 8 DRUG

RAY1216 dose 8 or Placebo

RAY1216 dose 8

RAY1216 dose 9 DRUG

RAY1216 dose 9 or Placebo with high fat meal

RAY1216 dose 9（food effect）

RAY1216 dose 10 DRUG

RAY1216 dose 10 or Placebo with high fat meal

RAY1216 dose 10（food effect）

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Raynovent Biotech Co., Ltd: lead

Study Sites (1)

The First Hospital of Jilin University

Jilin, China

Location

Related Publications (1)

• Hu Y, Li H, Wang K, Wu D, Zhang H, Ding Y, Wu J, Ye S, Peng Y, Liu L. Single- and multiple-dose pharmacokinetics and safety of the SARS-CoV-2 3CL protease inhibitor RAY1216: a phase 1 study in healthy participants. Antimicrob Agents Chemother. 2025 Mar 5;69(3):e0145024. doi: 10.1128/aac.01450-24. Epub 2025 Jan 31.

  PMID: 39887246 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Ritonavir

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

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

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 25, 2023
• Study Start: May 20, 2022
• Primary Completion: August 12, 2022
• Study Completion: August 12, 2022
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

CN (1)