A Phase I Clinical Study of SSD8432 in Healthy Adult Subjects

Study Overview
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Brief Summary
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This is a Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SSD8432 in Healthy Adult Subjects

Detailed Description
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108 healthy adult subjects (including 72 subjects in Part A to C, 16-24 subjects in Part D, and 8-12 subjects in optional Part E), including both males and females, will be enrolled in the phase I study. This study will include Five parts: SSD8432 single dose and SSD8432 co-administrated with ritonavir (Part A), SSD8432 multiple dose (Part B), SSD8432 co-administrated with ritonavir multiple dose (Part C), SSD8432 co-administered ritonavir single dose in fasting and postprandial states (Part D: assessment of food effects) and optional part (Part E: Assessment of the safety and pharmacokinetics of SSD8432 in white healthy adult subjects)

Official Title
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A Phase I, Single and Multiple Dose, to Evaluate the Safety, Tolerability, and Pharmacokinetics of SSD8432 and SSD8432 Co-administrated in Healthy Adult Subjects

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: SSD8432 dose 1 7 and Ritonavir
* Drug: SSD8432 dose 8 9
* Drug: SSD8432 dose 10 12 and ritonavir
* Drug: SSD8432 dose 13 and Ritonavir
* Drug: SSD8432 dose 14 and Ritonavir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male subjects' weight ≥ 50 kg, female subjects' weight ≥ 45 kg; body mass index ≥ 19 kg/m2 and ≤ 28 kg/m2. Female participants of child-bearing potential must agree to use adequate contraception from screening until 1 months after last dose. Exclusion Criteria: History of any other acute or chronic illness (including cardiovascular, pulmonary, neurological, hepatic, rheumatic, hematological, metabolic or renal disorders), or use of medication that, in the opinion of the Principal Investigator, may not suitable for participating in this study. Subjects with a history of hematophobia or trypanophobia and unable to tolerate intravenous indwelling needle blood sampling. History of dysphagia or any other gastrointestinal disease possibly affecting drug absorption. Take special diet and cannot abide by the provided food and corresponding requirements in this study. Subject with a history of clinically significant hypersensitivity reactions to the active substance of SSD8432 or ritonavir or to any other components of drug products.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SSD8432 dose 1 7<br>Dose level 1  7 of SSD8432 | Drug: SSD8432 dose 1 7 and Ritonavir<br>* Cohort 1 Period 1 single dose of SSD8432 dose 1 or placebo, on day 1. Period 2: single dose of SSD8432 dose 2 or placebo , on day 7. Period 3: single dose of SSD8432 dose 3 on day 13, ritonavir or placebo, before SSD8432 dose 3 and BID on SSD8432 dosing date Cohort 2: Period 1 single dose of SSD8432 dose 4 or placebo, on day 1 Period 2: single doses of SSD8432 dose 5 or placebo , on day 7 Period 3: single dose of SSD8432 dose 6 on day 13, ritonavir or placebo, before SSD8432 dose 3 and BID on SSD8432 dosing date Cohort 3: single dose of SSD8432 dose 7 or placebo on day1. ritonavir or placebo, before SSD8432 dose 7 and BID on SSD8432 dosing date.<br>|
| Experimental: SSD8432 dose 8 9<br>Dose level 8  9 of SSD8432 | Drug: SSD8432 dose 8 9<br>* Cohort 4: SSD8432 dose 8 or placebo, on day 1  day6. Cohort 5: SSD8432 dose 9 or placebo, on day 1  day6.<br>|
| Experimental: SSD8432 dose 10 12<br>Dose level 10  12 of SSD8432 | Drug: SSD8432 dose 10 12 and ritonavir<br>* Cohort 6: SSD8432 dose 10 or placebo, on day 1  day6. Cohort 7: SSD8432 dose 11 or placebo, on day 1  day6. Cohort 8: SSD8432 dose 12 or placebo, on day 1  day6 Cohort 9: to be decided<br>|
| Experimental: SSD8432 dose 13<br>Dose level 13 of SSD8432 | Drug: SSD8432 dose 13 and Ritonavir<br>* Cohort 10: Group A: SSD8432 dose 13, on day1 under fasting condition, on day 6 under fatty food condition, ritonavir, before SSD8432 dose 13 and BID on SSD8432 dosing date. Group B: SSD8432 dose 13, on day1 fatty food condition, on day 6 under fasting condition ,Ritonavir, before SSD8432 dose 13 and BID on SSD8432 dosing date<br>|
| Experimental: SSD8432 dose 14<br>Dose level 14 of SSD8432 | Drug: SSD8432 dose 14 and Ritonavir<br>* Cohort 11: to be decided<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Adverse events of SSD8432(Part A D) | Adverse events, including type, incidence, grade (determined with reference to NCI-CTCAE V5.0) | From signing ICF up to day 26 | 
| PK parameters(Part E) | Time for Cmax (Tmax) | Day 1 to Day 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameters(Part A D) | Time for Cmax (Tmax) | Day 1 to Day 4 | 
| The Adverse events of SSD8432(Part E) | Adverse events, including type, incidence, grade (determined with reference to NCI-CTCAE V5.0) | From signing ICF up to day 26 |