Healthy ParticipantsPhase 1NCT05339646
A Phase I Clinical Study of SSD8432 in Healthy Adult Subjects
A Phase 1 study testing SSD8432 dose 1~7 and Ritonavir, SSD8432 dose 8~9 and SSD8432 dose 10~12 and ritonavir in people with Healthy Participants, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SSD8432 in Healthy Adult Subjects Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- SSD8432 dose 1~7 and Ritonavir, SSD8432 dose 8~9 and SSD8432 dose 10~12 and ritonavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 7 Apr 2022to Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, 250014
Wei Zhao, Doctor, +86 0531-89268212, zhao4wei2@hotmail.com
About this study
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
This is a Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SSD8432 in Healthy Adult Subjects
Read the 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)
- Conditions
- Healthy Participants
- Being tested
- SSD8432 dose 1~7 and Ritonavir, SSD8432 dose 8~9, SSD8432 dose 10~12 and ritonavir, SSD8432 dose 13 and Ritonavir, SSD8432 dose 14 and Ritonavir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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 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 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 14 and RitonavirDrug
Cohort 11: to be decided
| Study group | Role | What they receive |
|---|---|---|
| SSD8432 dose 1~7 | Experimental | Dose level 1 ~7 of SSD8432 Receives: Drug: SSD8432 dose 1~7 and Ritonavir |
| SSD8432 dose 8~9 | Experimental | Dose level 8 ~9 of SSD8432 Receives: Drug: SSD8432 dose 8~9 |
| SSD8432 dose 10~12 | Experimental | Dose level 10 ~12 of SSD8432 Receives: Drug: SSD8432 dose 10~12 and ritonavir |
| SSD8432 dose 13 | Experimental | Dose level 13 of SSD8432 Receives: Drug: SSD8432 dose 13 and Ritonavir |
| SSD8432 dose 14 | Experimental | Dose level 14 of SSD8432 Receives: Drug: SSD8432 dose 14 and Ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Adverse events of SSD8432(Part A~D)
Adverse events, including type, incidence, grade (determined with reference to NCI-CTCAE V5.0)
Measured: From signing ICF up to day 26
PK parameters(Part E)
Time for Cmax (Tmax)
Measured: Day 1 to Day 4
Secondary outcomes (2)
PK parameters(Part A~D)
Time for Cmax (Tmax)
Measured: Day 1 to Day 4
The Adverse events of SSD8432(Part E)
Adverse events, including type, incidence, grade (determined with reference to NCI-CTCAE V5.0)
Measured: From signing ICF up to day 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start7 Apr 2022
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Jiangsu Simcere Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yumei Yang, Study director, Jiangsu Simcere Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339646
- Sponsor's protocol ID
- B02B11101-101
- Status last verified
- Apr 2022
- First submitted
- 7 Apr 2022
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40965470Yang 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.
PubMed 37783378
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05339646
- Acronym / sponsor ID
- B02B11101-101
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 21 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| SSD8432 dose 1~7 | Experimental | Drug: SSD8432 dose 1~7 and RitonavirDose level 1 ~7 of SSD8432 |
| SSD8432 dose 8~9 | Experimental | Drug: SSD8432 dose 8~9Dose level 8 ~9 of SSD8432 |
| SSD8432 dose 10~12 | Experimental | Drug: SSD8432 dose 10~12 and ritonavirDose level 10 ~12 of SSD8432 |
| SSD8432 dose 13 | Experimental | Drug: SSD8432 dose 13 and RitonavirDose level 13 of SSD8432 |
| SSD8432 dose 14 | Experimental | Drug: SSD8432 dose 14 and RitonavirDose level 14 of SSD8432 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SSD8432 dose 1~7 and RitonavirCohort 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. | Drug | SSD8432 dose 1~7 |
| SSD8432 dose 8~9Cohort 4: SSD8432 dose 8 or placebo, on day 1 ~day6. Cohort 5: SSD8432 dose 9 or placebo, on day 1 ~day6. | Drug | SSD8432 dose 8~9 |
| SSD8432 dose 10~12 and ritonavirCohort 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 | Drug | SSD8432 dose 10~12 |
| SSD8432 dose 13 and RitonavirCohort 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 | Drug | SSD8432 dose 13 |
| SSD8432 dose 14 and RitonavirCohort 11: to be decided | Drug | SSD8432 dose 14 |
Primary outcome
The Adverse events of SSD8432(Part A~D)
Time frame: 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)
Time frame: Day 1 to Day 4
Time for Cmax (Tmax)
2 secondary outcomes
PK parameters(Part A~D)
Time frame: Day 1 to Day 4
The Adverse events of SSD8432(Part E)
Time frame: From signing ICF up to day 26
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Derived from this study: PubMed 40965470Yao 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.
- Derived from this study: PubMed 37783378Yang 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.
- Individual participant dataSharing planned: No
Related trials for Healthy Participants
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
RecruitingPhase 1
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Healthy Female Participants
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yumei Yang study director
Jiangsu Simcere Pharmaceutical Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SSD8432 dose 1~7 and Ritonavir, SSD8432 dose 8~9 and SSD8432 dose 10~12 and ritonavir in people with Healthy Participants, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lily Chen (+86 025-85566666, chenlihua2@simcere.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Adverse events of SSD8432(Part A~D) (time frame: From signing ICF up to day 26). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05339646, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.