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

NCT ID: NCT05829551

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-20
• Study Completion Date: 2022-08-12

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

RAY1216 dose 1

SAD

Group Type: EXPERIMENTAL

RAY1216 dose 1

Intervention Type: DRUG

RAY1216 dose 1 or Placebo

RAY1216 dose 2

SAD

Group Type: EXPERIMENTAL

RAY1216 dose 2

Intervention Type: DRUG

RAY1216 dose 2 or Placebo

RAY1216 dose 3

SAD

Group Type: EXPERIMENTAL

RAY1216 dose 3

Intervention Type: DRUG

RAY1216 dose 3 or Placebo

RAY1216 dose 4（DDI）

drug-drug interaction

Group Type: EXPERIMENTAL

RAY1216 dose 4 &ritonavir

Intervention Type: DRUG

RAY1216 dose 4 \&ritonavir or Placebo

RAY1216 dose 5

MAD

Group Type: EXPERIMENTAL

RAY1216 dose 5

Intervention Type: DRUG

RAY1216 dose 5 or Placebo

RAY1216 dose 6

MAD

Group Type: EXPERIMENTAL

RAY1216 dose 6

Intervention Type: DRUG

RAY1216 dose 6 or Placebo

RAY1216 dose 7

MAD

Group Type: EXPERIMENTAL

RAY1216 dose 7

Intervention Type: DRUG

RAY1216 dose 7 or Placebo

RAY1216 dose 8

MAD

Group Type: EXPERIMENTAL

RAY1216 dose 8

Intervention Type: DRUG

RAY1216 dose 8 or Placebo

RAY1216 dose 9（food effect）

food effect on single dose

Group Type: EXPERIMENTAL

RAY1216 dose 9

Intervention Type: DRUG

RAY1216 dose 9 or Placebo with high fat meal

RAY1216 dose 10（food effect）

food effect on single dose

Group Type: EXPERIMENTAL

RAY1216 dose 10

Intervention Type: DRUG

RAY1216 dose 10 or Placebo with high fat meal

Interventions

RAY1216 dose 1

RAY1216 dose 1 or Placebo

Intervention Type: DRUG

RAY1216 dose 2

RAY1216 dose 2 or Placebo

Intervention Type: DRUG

RAY1216 dose 3

RAY1216 dose 3 or Placebo

Intervention Type: DRUG

RAY1216 dose 4 &ritonavir

RAY1216 dose 4 \&ritonavir or Placebo

Intervention Type: DRUG

RAY1216 dose 5

RAY1216 dose 5 or Placebo

Intervention Type: DRUG

RAY1216 dose 6

RAY1216 dose 6 or Placebo

Intervention Type: DRUG

RAY1216 dose 7

RAY1216 dose 7 or Placebo

Intervention Type: DRUG

RAY1216 dose 8

RAY1216 dose 8 or Placebo

Intervention Type: DRUG

RAY1216 dose 9

RAY1216 dose 9 or Placebo with high fat meal

Intervention Type: DRUG

RAY1216 dose 10

RAY1216 dose 10 or Placebo with high fat meal

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guangdong Raynovent Biotech Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Hospital of Jilin University

Jilin, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 39887246 (View on PubMed)

Other Identifiers

RAY1216-22-01

Identifier Type: -

Identifier Source: org_study_id