The Safety, Tolerability and Pharmacokinetics Study of RAY1216 in Healthy Adult Participants
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: RAY1216 dose 1 SAD |
Drug: RAY1216 dose 1
RAY1216 dose 1 or Placebo
|
| Experimental: RAY1216 dose 2 SAD |
Drug: RAY1216 dose 2
RAY1216 dose 2 or Placebo
|
| Experimental: RAY1216 dose 3 SAD |
Drug: RAY1216 dose 3
RAY1216 dose 3 or Placebo
|
| Experimental: RAY1216 dose 4（DDI） drug-drug interaction |
Drug: RAY1216 dose 4 &ritonavir
RAY1216 dose 4 &ritonavir or Placebo
|
| Experimental: RAY1216 dose 5 MAD |
Drug: RAY1216 dose 5
RAY1216 dose 5 or Placebo
|
| Experimental: RAY1216 dose 6 MAD |
Drug: RAY1216 dose 6
RAY1216 dose 6 or Placebo
|
| Experimental: RAY1216 dose 7 MAD |
Drug: RAY1216 dose 7
RAY1216 dose 7 or Placebo
|
| Experimental: RAY1216 dose 8 MAD |
Drug: RAY1216 dose 8
RAY1216 dose 8 or Placebo
|
| Experimental: RAY1216 dose 9（food effect） food effect on single dose |
Drug: RAY1216 dose 9
RAY1216 dose 9 or Placebo with high fat meal
|
| Experimental: RAY1216 dose 10（food effect） food effect on single dose |
Drug: RAY1216 dose 10
RAY1216 dose 10 or Placebo with high fat meal
|
Outcome Measures
Primary Outcome Measures
- 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 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
- 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
Secondary Outcome Measures
- 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]
- To determine the single and multiple oral dose pharmacokinetic profiles of RAY1216(Cmin) [Day 1 to Day 9]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
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Subjects (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product.
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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.
Exclusion Criteria:
-
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.
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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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Hospital of Jilin University | Jilin | China |
Sponsors and Collaborators
- Guangdong Raynovent Biotech Co., Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RAY1216-22-01