To Evaluate SSD8432/ Ritonavir in Adults With COVID-19

NCT05369676 | Completed Phase 1

• 1 other identifier: B02B11101-103
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, Phase 1b clinical trial to evaluate the safety, Pharmacodynamics, and Pharmacokinetic of SSD8432 combined with ritonavir tablets in adults with COVID-19.

Conditions

COVID-19 Patients

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Frequency of TEAE

  Baseline through Day 28

Secondary Outcomes (5)

• Viral load

  Baseline through Day 28

• Time to Sustained Alleviation

  Baseline through Day 28

• Proportion of Participants Progressing to a Worsening Status (higher score)

  Baseline through Day 28

• Maximum Plasma Concentration [Cmax]

  Baseline through Day 5

• Area Under the Plasma concentration-time Curve [AUC]

  Baseline through Day 5

Study Arms (2)

SSD8432 dose 1

EXPERIMENTAL

SSD8432 dose 1/ritonavir or placebo

Drug: SSD8432 dose 1/Ritonavir

SSD8432 dose 2

EXPERIMENTAL

SSD8432 dose 2/ritonavir or placebo

Drug: SSD8432 dose 2/Ritonavir

Interventions

SSD8432 dose 1/Ritonavir DRUG

Cohort 1:SSD8432/ritonavir or placebo, on day 1 \~day5，BID；

Also known as: SIM0417 dose 1/Ritonavir

SSD8432 dose 1

SSD8432 dose 2/Ritonavir DRUG

Cohort 2:SSD8432/ritonavir or placebo, on day 1 \~day5，BID；

Also known as: SIM0417 dose 2/Ritonavir

SSD8432 dose 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 and ≤75, male or female.
• Asymptomatic Infection, Mild, or Common Type of COVID-19.
• Initial positive test of SARS-Cov-2 within 5 days of randomization.
• Initial onset of COVID-19 signs/symptoms within 3 days of randomization.
• The Ct value of SARS-COV-2 nucleic acid test before randomization is ≤ 25, or the Ct value is \>25 and sarS-COV-2 serum IgG and IgM are negative.

You may not qualify if:

• Transnasal high-flow oxygen therapy or non-invasive ventilation, invasive mechanical ventilation, or ECMO is required or anticipated to be urgently required.
• Prior to current disease episode, any confirmed SARS-CoV-2 infection.
• Known medical history of active liver disease (other than nonalcoholic hepatic steatosis).
• Receiving dialysis or have known moderate to severe renal impairment.
• Known human immunodeficiency virus (HIV) infection.
• Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.s.
• Oxygen saturation of ≤ 93% on room air obtained at rest within 24 hours prior to randomization..
• Treatment with antivirals against SARS-CoV-2 within 14 days.
• Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance.
• Concomitant use of any medications or substances that are strong inducers of CYP3A4 are prohibited within 28 days.
• Has received or is expected to receive COVID-19 monoclonal antibody, convalescent COVID-19 plasma or other prohibited concomitant medication.
• Females who are pregnant or breastfeeding.

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shenzhen Third People's Hospital

Shenzhen, Guangdong, 518100, China

Location

Related Publications (2)

• Yao B-F, Yang Y, Xu S-S, Tang B-H, Chen J, Guo Z-J, Hu H-L, Zhang W, Fu S-M, Zhang X-F, Hao G-X, Yang X-M, Song L-L, Ye P-P, Liu L, Zhu S-W, Zheng Y, Zhao W. Model-informed drug development in public health emergency of international concern: accelerating marketing authorization of simnotrelvir. Antimicrob Agents Chemother. 2025 Nov 5;69(11):e0061425. doi: 10.1128/aac.00614-25. Epub 2025 Sep 18.

  PMID: 40965470 DERIVED

• Wang F, Xiao W, Tang Y, Cao M, Shu D, Asakawa T, Xu Y, Jiang X, Zhang L, Wang W, Tang J, Huang Y, Yang Y, Yang Y, Tang R, Shen J, Lu H. Efficacy and safety of SIM0417 (SSD8432) plus ritonavir for COVID-19 treatment: a randomised, double-blind, placebo-controlled, phase 1b trial. Lancet Reg Health West Pac. 2023 Jul 11;38:100835. doi: 10.1016/j.lanwpc.2023.100835. eCollection 2023 Sep.

  PMID: 37484496 DERIVED

Study Officials

• Yumei Yang

  Jiangsu Xiansheng Pharmaceutical Co., LTD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2022
• First Posted: May 11, 2022
• Study Start: May 12, 2022
• Primary Completion: August 29, 2022
• Study Completion: August 29, 2022
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)