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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05339646

Enrollment

108

Registered

2022-04-21

Start date

2022-04-07

Completion date

2022-12-31

Last updated

2022-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

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)

Interventions

DRUGSSD8432 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.

DRUGSSD8432 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.

DRUGSSD8432 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

DRUGSSD8432 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

DRUGSSD8432 dose 14 and Ritonavir

Cohort 11: to be decided

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

China

Contacts

Primary ContactLily Chen

chenlihua2@simcere.com+86 025-85566666

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026