A Phase I Clinical Study of SSD8432 in Healthy Adult Subjects

Simcere

Status and phase: Unknown; Phase 1

Conditions: Healthy Participants

Treatments: Drug: SSD8432 dose 14 and Ritonavir; Drug: SSD8432 dose 10~12 and ritonavir; Drug: SSD8432 dose 8~9; Drug: SSD8432 dose 13 and Ritonavir; Drug: SSD8432 dose 1~7 and Ritonavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT05339646

B02B11101-101

Details and patient eligibility

About

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

Full 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)

Enrollment: 108 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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108 participants in 5 patient groups

SSD8432 dose 1~7

Experimental group

Description:

Dose level 1 \~7 of SSD8432

Treatment:

Drug: SSD8432 dose 1~7 and Ritonavir

SSD8432 dose 8~9

Experimental group

Description:

Dose level 8 \~9 of SSD8432

Treatment:

Drug: SSD8432 dose 8~9

SSD8432 dose 10~12

Experimental group

Description:

Dose level 10 \~12 of SSD8432

Treatment:

Drug: SSD8432 dose 10~12 and ritonavir

SSD8432 dose 13

Experimental group

Description:

Dose level 13 of SSD8432

Treatment:

Drug: SSD8432 dose 13 and Ritonavir

SSD8432 dose 14

Experimental group

Description:

Dose level 14 of SSD8432

Treatment:

Drug: SSD8432 dose 14 and Ritonavir