A Phase I Clinical Study of SSD8432 in Healthy Adult Subjects

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

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

Study Overview

• Status: Recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: 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

Detailed Description

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)

• Study Type: Interventional
• Enrollment (Anticipated): 108
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Lily Chen; Phone Number: +86 025-85566666; Email: chenlihua2@simcere.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250014
      • Recruiting
      • The First Affiliated Hospital of Shandong First Medical University
      • Contact: Wei Zhao, Doctor; Phone Number: +86 0531-89268212; Email: zhao4wei2@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SSD8432 dose 1~7; Dose level 1 ~7 of SSD8432	Drug: SSD8432 dose 1~7 and Ritonavir; 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.
Experimental: SSD8432 dose 8~9; Dose level 8 ~9 of SSD8432	Drug: SSD8432 dose 8~9; Cohort 4: SSD8432 dose 8 or placebo, on day 1 ~day6. Cohort 5: SSD8432 dose 9 or placebo, on day 1 ~day6.
Experimental: SSD8432 dose 10~12; Dose level 10 ~12 of SSD8432	Drug: SSD8432 dose 10~12 and ritonavir; 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
Experimental: SSD8432 dose 13; Dose level 13 of SSD8432	Drug: SSD8432 dose 13 and Ritonavir; 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
Experimental: SSD8432 dose 14; Dose level 14 of SSD8432	Drug: SSD8432 dose 14 and Ritonavir; Cohort 11: to be decided

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Investigators: Study Director: Yumei Yang, Jiangsu Simcere Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2022
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: April 7, 2022
• First Submitted That Met QC Criteria: April 15, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 21, 2022
• Last Update Submitted That Met QC Criteria: April 15, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Ritonavir
• Other Study ID Numbers: B02B11101-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No