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CompletedNCT05829551Updated Apr 25, 2023

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

A Phase 1 interventional study of RAY1216 dose 1 and RAY1216 dose 2 in COVID-19 (Coronavirus Disease 2019), sponsored by Guangdong Raynovent Biotech Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-25.

Sponsored by Guangdong Raynovent Biotech Co., Ltd · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled May 2022, registered Apr 2023).
Phase
Phase 1
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • COVID-19 (Coronavirus Disease 2019)

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03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 88 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Guangdong Raynovent Biotech Co., Ltd is the lead sponsor of 35 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
88 participants (actual)

Study arms

  • Experimental
    RAY1216 dose 1

    SAD

    Drug: RAY1216 dose 1

  • Experimental
    RAY1216 dose 2

    SAD

    Drug: RAY1216 dose 2

  • Experimental
    RAY1216 dose 3

    SAD

    Drug: RAY1216 dose 3

  • Experimental
    RAY1216 dose 4（DDI）

    drug-drug interaction

    Drug: RAY1216 dose 4 &ritonavir

  • Experimental
    RAY1216 dose 5

    MAD

    Drug: RAY1216 dose 5

  • Experimental
    RAY1216 dose 6

    MAD

    Drug: RAY1216 dose 6

  • Experimental
    RAY1216 dose 7

    MAD

    Drug: RAY1216 dose 7

  • Experimental
    RAY1216 dose 8

    MAD

    Drug: RAY1216 dose 8

  • Experimental
    RAY1216 dose 9（food effect）

    food effect on single dose

    Drug: RAY1216 dose 9

  • Experimental
    RAY1216 dose 10（food effect）

    food effect on single dose

    Drug: RAY1216 dose 10

Interventions

  • DrugRAY1216 dose 1

    RAY1216 dose 1 or Placebo

  • DrugRAY1216 dose 2

    RAY1216 dose 2 or Placebo

  • DrugRAY1216 dose 3

    RAY1216 dose 3 or Placebo

  • DrugRAY1216 dose 4 &ritonavir

    RAY1216 dose 4 \&ritonavir or Placebo

  • DrugRAY1216 dose 5

    RAY1216 dose 5 or Placebo

  • DrugRAY1216 dose 6

    RAY1216 dose 6 or Placebo

  • DrugRAY1216 dose 7

    RAY1216 dose 7 or Placebo

  • DrugRAY1216 dose 8

    RAY1216 dose 8 or Placebo

  • DrugRAY1216 dose 9

    RAY1216 dose 9 or Placebo with high fat meal

  • DrugRAY1216 dose 10

    RAY1216 dose 10 or Placebo with high fat meal

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Day 1 to Day 5

  2. 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

    Time frame: Day 1 to Day 9

  3. 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

    Time frame: Day 1 to Day 15

  4. 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

    Time frame: Day 1 to Day 21

Secondary outcomes

  1. To determine the effect of food on the PK of RAY1216 single dose(Cmax)

    Time frame: Day 1 to Day 21

  2. To investigate the effect of Ritonavir on the pharmacokinetics of RAY1216(Cmax)

    Time frame: Day 1 to Day 15

  3. To determine the single and multiple oral dose pharmacokinetic profiles of RAY1216(Cmax)

    Time frame: Day 1 to Day 9

  4. To determine the effect of food on the PK of RAY1216 single dose(AUC0-∞)

    Time frame: Day 1 to Day 21

  5. To investigate the effect of Ritonavir on the pharmacokinetics of RAY1216(AUC0-∞)

    Time frame: Day 1 to Day 15

  6. To determine the single and multiple oral dose pharmacokinetic profiles of RAY1216(Cmin)

    Time frame: Day 1 to Day 9

07

Study locations

1 site
  • The First Hospital of Jilin University
    Jilin, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05829551
Lead sponsor
Guangdong Raynovent Biotech Co., Ltd
Responsible party
Sponsor
First posted
Apr 25, 2023
Start date
May 20, 2022
Primary completion
Aug 12, 2022
Completion
Aug 12, 2022
Last update
Apr 25, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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