COVID-19 (Coronavirus Disease 2019)Phase 1NCT05829551
The Safety, Tolerability and Pharmacokinetics Study of RAY1216 in Healthy Adult Participants
A Phase 1 study testing RAY1216 dose 1, RAY1216 dose 2 and RAY1216 dose 3 in people with COVID-19 (Coronavirus Disease 2019), run by Guangdong Raynovent Biotech Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 (Coronavirus Disease 2019)
- What is being tested?
- RAY1216 dose 1, RAY1216 dose 2 and RAY1216 dose 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2022to 12 Aug 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics of RAY1216 and the Effect of Food on RAY1216 Pharmacokinetics in Healthy Adult Participants
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)
- Being tested
- RAY1216 dose 1, RAY1216 dose 2, RAY1216 dose 3, RAY1216 dose 4 &ritonavir, RAY1216 dose 5
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAY1216 dose 1Drug
RAY1216 dose 1 or Placebo
RAY1216 dose 2Drug
RAY1216 dose 2 or Placebo
RAY1216 dose 3Drug
RAY1216 dose 3 or Placebo
RAY1216 dose 4 &ritonavirDrug
RAY1216 dose 4 \&ritonavir or Placebo
RAY1216 dose 5Drug
RAY1216 dose 5 or Placebo
RAY1216 dose 6Drug
RAY1216 dose 6 or Placebo
RAY1216 dose 7Drug
RAY1216 dose 7 or Placebo
RAY1216 dose 8Drug
RAY1216 dose 8 or Placebo
RAY1216 dose 9Drug
RAY1216 dose 9 or Placebo with high fat meal
RAY1216 dose 10Drug
RAY1216 dose 10 or Placebo with high fat meal
| Study group | Role | What they receive |
|---|---|---|
| RAY1216 dose 1 | Experimental | SAD Receives: Drug: RAY1216 dose 1 |
| RAY1216 dose 2 | Experimental | SAD Receives: Drug: RAY1216 dose 2 |
| RAY1216 dose 3 | Experimental | SAD Receives: Drug: RAY1216 dose 3 |
| RAY1216 dose 4（DDI） | Experimental | drug-drug interaction Receives: Drug: RAY1216 dose 4 &ritonavir |
| RAY1216 dose 5 | Experimental | MAD Receives: Drug: RAY1216 dose 5 |
| RAY1216 dose 6 | Experimental | MAD Receives: Drug: RAY1216 dose 6 |
| RAY1216 dose 7 | Experimental | MAD Receives: Drug: RAY1216 dose 7 |
| RAY1216 dose 8 | Experimental | MAD Receives: Drug: RAY1216 dose 8 |
| RAY1216 dose 9（food effect） | Experimental | food effect on single dose Receives: Drug: RAY1216 dose 9 |
| RAY1216 dose 10（food effect） | Experimental | food effect on single dose Receives: Drug: RAY1216 dose 10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 1 to Day 21
Secondary outcomes (6)
To determine the effect of food on the PK of RAY1216 single dose(Cmax)
Measured: Day 1 to Day 21
To investigate the effect of Ritonavir on the pharmacokinetics of RAY1216(Cmax)
Measured: Day 1 to Day 15
To determine the single and multiple oral dose pharmacokinetic profiles of RAY1216(Cmax)
Measured: Day 1 to Day 9
To determine the effect of food on the PK of RAY1216 single dose(AUC0-∞)
Measured: Day 1 to Day 21
To investigate the effect of Ritonavir on the pharmacokinetics of RAY1216(AUC0-∞)
Measured: Day 1 to Day 15
To determine the single and multiple oral dose pharmacokinetic profiles of RAY1216(Cmin)
Measured: Day 1 to Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start20 May 2022
- Primary completion12 Aug 2022
- Study completion12 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19 (Coronavirus Disease 2019)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Raynovent Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829551
- Sponsor's protocol ID
- RAY1216-22-01
- Status last verified
- Apr 2023
- First submitted
- 3 Apr 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39887246
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety, Tolerability, Pharmacokinetics of RAY1216 and the Effect of Food on RAY1216 Pharmacokinetics in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT05829551
- Acronym / sponsor ID
- RAY1216-22-01
- Conditions
- COVID-19 (Coronavirus Disease 2019)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Guangdong Raynovent Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 20 May 2022 (actual)
- Primary completion
- 12 Aug 2022 (actual)
- Study completion
- 12 Aug 2022 (actual)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| RAY1216 dose 1 | Experimental | Drug: RAY1216 dose 1SAD |
| RAY1216 dose 2 | Experimental | Drug: RAY1216 dose 2SAD |
| RAY1216 dose 3 | Experimental | Drug: RAY1216 dose 3SAD |
| RAY1216 dose 4（DDI） | Experimental | Drug: RAY1216 dose 4 &ritonavirdrug-drug interaction |
| RAY1216 dose 5 | Experimental | Drug: RAY1216 dose 5MAD |
| RAY1216 dose 6 | Experimental | Drug: RAY1216 dose 6MAD |
| RAY1216 dose 7 | Experimental | Drug: RAY1216 dose 7MAD |
| RAY1216 dose 8 | Experimental | Drug: RAY1216 dose 8MAD |
| RAY1216 dose 9（food effect） | Experimental | Drug: RAY1216 dose 9food effect on single dose |
| RAY1216 dose 10（food effect） | Experimental | Drug: RAY1216 dose 10food effect on single dose |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAY1216 dose 1RAY1216 dose 1 or Placebo | Drug | RAY1216 dose 1 |
| RAY1216 dose 2RAY1216 dose 2 or Placebo | Drug | RAY1216 dose 2 |
| RAY1216 dose 3RAY1216 dose 3 or Placebo | Drug | RAY1216 dose 3 |
| RAY1216 dose 4 &ritonavirRAY1216 dose 4 \&ritonavir or Placebo | Drug | RAY1216 dose 4（DDI） |
| RAY1216 dose 5RAY1216 dose 5 or Placebo | Drug | RAY1216 dose 5 |
| RAY1216 dose 6RAY1216 dose 6 or Placebo | Drug | RAY1216 dose 6 |
| RAY1216 dose 7RAY1216 dose 7 or Placebo | Drug | RAY1216 dose 7 |
| RAY1216 dose 8RAY1216 dose 8 or Placebo | Drug | RAY1216 dose 8 |
| RAY1216 dose 9RAY1216 dose 9 or Placebo with high fat meal | Drug | RAY1216 dose 9（food effect） |
| RAY1216 dose 10RAY1216 dose 10 or Placebo with high fat meal | Drug | RAY1216 dose 10（food effect） |
Primary outcome
Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE) in single ascending dose
Time frame: 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
Time frame: 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 DDI part
Time frame: Day 1 to Day 15
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
Time frame: Day 1 to Day 21
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported
6 secondary outcomes
To determine the effect of food on the PK of RAY1216 single dose(Cmax)
Time frame: Day 1 to Day 21
To investigate the effect of Ritonavir on the pharmacokinetics of RAY1216(Cmax)
Time frame: Day 1 to Day 15
To determine the single and multiple oral dose pharmacokinetic profiles of RAY1216(Cmax)
Time frame: Day 1 to Day 9
To determine the effect of food on the PK of RAY1216 single dose(AUC0-∞)
Time frame: Day 1 to Day 21
To investigate the effect of Ritonavir on the pharmacokinetics of RAY1216(AUC0-∞)
Time frame: Day 1 to Day 15
To determine the single and multiple oral dose pharmacokinetic profiles of RAY1216(Cmin)
Time frame: Day 1 to Day 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Derived from this study: PubMed 39887246Hu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RAY1216 dose 1, RAY1216 dose 2 and RAY1216 dose 3 in people with COVID-19 (Coronavirus Disease 2019), run by Guangdong Raynovent Biotech Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE) in single ascending dose (time frame: Day 1 to Day 5). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05829551, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.