A Phase I Clinical Study of SSD8432 in Healthy Adult Subjects

Phase 1

• Conditions: Healthy Participants
• Interventions: Drug: SSD8432 dose 8~9; Drug: SSD8432 dose 14 and Ritonavir; Drug: SSD8432 dose 13 and Ritonavir; Drug: SSD8432 dose 1~7 and Ritonavir; Drug: SSD8432 dose 10~12 and ritonavir

• Registration Number: NCT05339646
• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

Brief Summary

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

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 Timeline

• Status Verified: 2022-04
• Study Start: 2022-04-07
• Study First Submitted: 2022-04-07
• Study First Submitted QC: 2022-04-15
• Last Update Submitted: 2022-04-15
• Study First Posted: 2022-04-21
• Last Update Posted: 2022-04-21
• Primary Completion: 2022-10
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 108

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SSD8432 dose 8~9	SSD8432 dose 8~9	Dose level 8 \~9 of SSD8432
SSD8432 dose 14	SSD8432 dose 14 and Ritonavir	Dose level 14 of SSD8432
SSD8432 dose 13	SSD8432 dose 13 and Ritonavir	Dose level 13 of SSD8432
SSD8432 dose 1~7	SSD8432 dose 1~7 and Ritonavir	Dose level 1 \~7 of SSD8432
SSD8432 dose 10~12	SSD8432 dose 10~12 and ritonavir	Dose level 10 \~12 of SSD8432

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The First Affiliated Hospital of Shandong First Medical University; 🇨🇳 Jinan, Shandong, China