NCT05339646

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2022

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

April 7, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

April 21, 2022

Status Verified

April 1, 2022

Enrollment Period

6 months

First QC Date

April 7, 2022

Last Update Submit

April 15, 2022

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (2)

  • 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

  • PK parameters(Part E)

    Time for Cmax (Tmax)

    Day 1 to Day 4

Secondary Outcomes (2)

  • PK parameters(Part A~D)

    Day 1 to Day 4

  • The Adverse events of SSD8432(Part E)

    From signing ICF up to day 26

Study Arms (5)

SSD8432 dose 1~7

EXPERIMENTAL

Dose level 1 \~7 of SSD8432

Drug: SSD8432 dose 1~7 and Ritonavir

SSD8432 dose 8~9

EXPERIMENTAL

Dose level 8 \~9 of SSD8432

Drug: SSD8432 dose 8~9

SSD8432 dose 10~12

EXPERIMENTAL

Dose level 10 \~12 of SSD8432

Drug: SSD8432 dose 10~12 and ritonavir

SSD8432 dose 13

EXPERIMENTAL

Dose level 13 of SSD8432

Drug: SSD8432 dose 13 and Ritonavir

SSD8432 dose 14

EXPERIMENTAL

Dose level 14 of SSD8432

Drug: SSD8432 dose 14 and Ritonavir

Interventions

SSD8432 dose 1~7 and RitonavirDRUG

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 1~7
SSD8432 dose 8~9DRUG

Cohort 4: SSD8432 dose 8 or placebo, on day 1 \~day6. Cohort 5: SSD8432 dose 9 or placebo, on day 1 \~day6.

SSD8432 dose 8~9
SSD8432 dose 10~12 and ritonavirDRUG

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 10~12
SSD8432 dose 13 and RitonavirDRUG

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 13
SSD8432 dose 14 and RitonavirDRUG

Cohort 11: to be decided

SSD8432 dose 14

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, 250014, China

RECRUITING

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: 40965470DERIVED

  • Yang XM, Yang Y, Yao BF, Ye PP, Xu Y, Peng SP, Yang YM, Shu P, Li PJ, Li S, Hu HL, Li Q, Song LL, Chen KG, Zhou HY, Zhang YH, Zhao FR, Tang BH, Zhang W, Zhang XF, Fu SM, Hao GX, Zheng Y, Shen JS, Xu YC, Jiang XR, Zhang LK, Tang RH, Zhao W. A first-in-human phase 1 study of simnotrelvir, a 3CL-like protease inhibitor for treatment of COVID-19, in healthy adult subjects. Eur J Pharm Sci. 2023 Dec 1;191:106598. doi: 10.1016/j.ejps.2023.106598. Epub 2023 Sep 30.

    PMID: 37783378DERIVED

MeSH Terms

Interventions

Ritonavir

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Yumei Yang

    Jiangsu Simcere Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Central Study Contacts

Lily Chen

CONTACT

+86 025-85566666chenlihua2@simcere.com

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

April 7, 2022

First Posted

April 21, 2022

Study Start

April 7, 2022

Primary Completion

October 1, 2022

Study Completion

December 1, 2022

Last Updated

April 21, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)