A Phase I Clinical Study of SSD8432 in Healthy Adult Subjects

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05339646
• Other study ID #: B02B11101-101
• Status: Recruiting
• Phase: Phase 1
• Start date: April 7, 2022
• Est. completion date: December 2022

Study information

• Verified date: April 2022
• Source: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Contact: Lily Chen
• Phone: +86 025-85566666
• Email: chenlihua2[@]simcere.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: December 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

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.
• 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.
• 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
• 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
• SSD8432 dose 14 and Ritonavir
Cohort 11: to be decided

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Shandong First Medical University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Simcere Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	PK parameters(Part E)	Time for Cmax (Tmax)	Day 1 to Day 4
Secondary	PK parameters(Part A~D)	Time for Cmax (Tmax)	Day 1 to Day 4
Secondary	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