Healthy VolunteersPhase 1NCT06022354
To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SIM0278 in Chinese Healthy Subjects
A Phase 1 study of Healthy Volunteers, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a Phase 1, randomized, double-blind, placebo-controlled trial of SIM0278 in healthy subjects. The study will be conducted in 2 parts. Part 1 is single ascending dose study. Part 2 is multiple ascending dose study. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 23 Aug 2023to 22 Jul 2025
- 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
- Subject must be 18 to 55 years of age (inclusive), at the time of signing the informed consent.
- Body Mass Index (BMI) ≥ 18 and ≤ 28 kg/m2 and weight at least 45 kg at screening.
- A condition of general good health, as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, vital signs, laboratory profile, a 12-lead electrocardiogram (ECG) and chest X-ray.
- A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) as defined in, OR
- A WOCBP who agrees to follow the contraceptive guidance in from screening through at least 90 days after the last dose of study drug; a WOCBP must have a negative beta-human chorionic gonadotropin (β-hCG) test at screening and baseline prior to administration of investigational product.
- A male subject must agree to use contraception as detailed in this protocol from screening through at least 90 days after the last dose of study drug. Sperm donation is also restricted during the time-frame that males must practice highly effective method of contraception. This criterion may be waived for male subjects who have had a vasectomy more than (>) 90 days prior to screening.
- Must voluntarily sign and date each informed consent approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
Who cannot join
- History of significant sensitivity to any drug or previous severe adverse reaction to subcutaneous medication.
- Subject has a history of any clinically significant cardiac, respiratory (including asthma, bronchospasm), renal, hepatic, gastrointestinal, psychiatric, neurologic, hematologic or rheumatic disease, or psychiatric disease or disorder, current acute or chronic infections, or other abnormality that may affect safety, or potentially influence the study results, judged by the investigator.
- Chronic or active infection(s) requiring treatment with intravenous anti-infectives within 4 weeks prior to the dose of study drug, or oral anti-infectives within 2 weeks prior to Day 1, or positive test for novel coronavirus antigen or nucleic acid within 4 weeks prior to first dose
- Evidence or history of malignancy other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma.
- History of chronic or active hepatitis, or current positive result, including hepatitis B or hepatitis C infection, as evidenced by a positive test for hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab).
- History of tuberculosis (TB), or active or latent TB on the basis of positive medical history.
Show all 26Show fewer
- History of or positive screening test for human immunodeficiency virus (HIV) infection; any genetic, congenital, or acquired immunodeficiency syndrome, or any chronic recurring infections (including mucocutaneous candidiasis).
- Systolic blood pressure (BP) ≥ 140 mmHg or ≤ 90 mmHg, or diastolic BP≥ 90 mmHg or ≤50 mm Hg, or HR > 100 bpm, at Screening or baseline，and abnormal clinically significant should be judged by the investigator
- Subjects with ANY of the following abnormalities in clinical laboratory tests at screening:
- Neutrophil or lymphocyte counts below the normal range; Eosinophil count above the normal range.
- Estimated glomerular filtration rate (GFR) by Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) calculation ≤90 mL/min/1.73 m2 at screening.
- Aspartate aminotransferase (AST)、Alanine transaminase (ALT) >1.5 x upper limit of normal (ULN)
- Total bilirubin >1.2 x ULN
- Other clinically significant abnormalities of laboratory assessments, as judged by the Investigator and/or sponsor Medical Monitor, that could affect the safety of the subject, or the interpretation of the data from the study.
- 12-lead ECG demonstrating QTcF≥450 msec（male）or QTcF≥470 msec（female） at Screening. Subject who have II or III degree atrioventricular block or other clinically significant electrocardiogram abnormalitieshas, in the opinion of the investigator, are unsuitable subjects in the study.
- Use of prescription or non-prescription drugs (including recreational drugs and herbal medications) within 14 days or 5 half-lives (whichever is longer) prior to Day 1 and/or within the duration of the study.
- Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.
- Prior administration of any IL-2 based product.
- Exposure to immune-modulating medications (including topical or systemic use of corticosteroids) within 4 weeks prior to Day 1.
- Receipt of any investigational product within 3 months or 5 half-lives (whichever is longer) prior to Day 1.
- Will have live vaccine or attenuated live vaccine shots within the 12 weeks prior to Day 1, or planning to receive these vaccines at any time during study period or within 8 weeks after last dose.
- Current or history of regular alcohol abuse（14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine）within 6 months prior to day 1. OR Positive screen for alcohol breath test during screening period.
- Take more than 10 cigarettes/day within the last 3 months prior to day 1, and/or unwilling to stop using any tobacco products during the study duration.
- History of substance abuse, or a positive urine drug screen within 5 years prior to Screening, or urine drug screening result is positive.
- Donation or loss of 400 mL or more blood volume (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to Day 1.
- Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to enroll this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Hospital of Qingdao University
Qingdao, China, Shandong, 266001
About this study
Official title: A Single-center, Randomized, Double-blind, Sponsor Open, Placebo-controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SIM0278 After Single and Multiple Subcutaneous Injections in Chinese Healthy Subjects
This is a Phase 1, randomized, double-blind, placebo-controlled trial of SIM0278 in healthy subjects. The study will be conducted in 2 parts. Part 1 is single ascending dose study. Part 2 is multiple ascending dose study.
Read the detailed description
The study will assess the safety, tolerability, and pharmacokinetics（PK） after a single or multiple administration of SIM0278 or placebo via subcutaneous injection in healthy subjects (male or female) where PK, pharmacodynamics (PD) and biomarkers will be assessed. Approximately 68 subjects (up to 84) will be enrolled in the whole study. The ratio of active drug to placebo in each dose level will be 3:1. In part1, approximately 44 subjects (up to 52) will be enrolled for the single dose escalation. Six dose levels are planned in part 1. In part2, approximately 24 (up to 32) subjects will be enrolled for the multiple dose escalation. Three dose levels are planned in part 2.
- Conditions
- Healthy Volunteers
- Being tested
- SIM0278 Injection/Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIM0278 Injection/PlaceboDrug
SIM0278 Injection/Placebo
| Study group | Role | What they receive |
|---|---|---|
| Part 1 : cohort 1: SIM0278 or placebo | Experimental | Not described Receives: Drug: SIM0278 Injection/Placebo |
| Part 1 : cohort 2: SIM0278 or placebo | Experimental | Not described Receives: Drug: SIM0278 Injection/Placebo |
| Part 1 : cohort 3: SIM0278 or placebo | Experimental | Not described Receives: Drug: SIM0278 Injection/Placebo |
| Part 1 : cohort 4: SIM0278 or placebo | Experimental | Not described Receives: Drug: SIM0278 Injection/Placebo |
| Part 1 : cohort 5: SIM0278 or placebo | Experimental | Not described Receives: Drug: SIM0278 Injection/Placebo |
| Part 1 : cohort 6: SIM0278 or placebo | Experimental | Not described Receives: Drug: SIM0278 Injection/Placebo |
| Part 1 : cohort 7: SIM0278 or placebo | Experimental | Not described Receives: Drug: SIM0278 Injection/Placebo |
| Part 2 : cohort 1: SIM0278 or placebo | Experimental | Not described Receives: Drug: SIM0278 Injection/Placebo |
| Part 2 : cohort 2: SIM0278 or placebo | Experimental | Not described Receives: Drug: SIM0278 Injection/Placebo |
| Part 2 : cohort 3: SIM0278 or placebo | Experimental | Not described Receives: Drug: SIM0278 Injection/Placebo |
| Part 2 : cohort 4: SIM0278 or placebo | Experimental | Not described Receives: Drug: SIM0278 Injection/Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) of subcutaneous injections of SIM0278 in healthy subjects after single dose (Part 1) or multiple dose (Part 2) administration
Measured: Part 1:up to 29 days after the first dose of treatment; Part 2:up to 85 days after the first dose of treatment
Secondary outcomes (7)
Peak plasma concentration(Cmax) of SIM0278 in serum
Cmax was measured for SIM0278 administered by subcutaneous injection
Measured: Time Frame: Part 1:up to 29 days after the first dose of treatment; Part 2:up to 57 days after the first dose of treatment
Time to reach maximum concentration (Tmax) of SIM0278 in serum
Tmax was measured for SIM0278 administered by subcutaneous injection
Measured: Part 1:up to 29 days after the first dose of treatment; Part 2:up to 57 days after the first dose of treatment
Area under the curve (AUC) of SIM0278in serum
AUC was measured for SIM0278 administered by subcutaneous injection
Measured: Part 1:up to 29 days after the first dose of treatment; Part 2:up to 57 days after the first dose of treatment
Half life (T1/2) of SIM0278 in serum
T1/2 was measured for SIM0278 administered by subcutaneous injection
Measured: Part 1:up to 29 days after the first dose of treatment; Part 2:up to 57 days after the first dose of treatment
Total body clearance (CL/F) of SIM0278 in serum
CL/F was measured for SIM0278 administered by subcutaneous injection
Measured: Part 1:up to 29 days after the first dose of treatment; Part 2:up to 57 days after the first dose of treatment
Total volume of distribution（Vd） at the terminal phase of SIM0278 in serum
Vd was measured for SIM0278 administered by subcutaneous injection
Measured: Part 1:up to 29 days after the first dose of treatment; Part 2:up to 57 days after the first dose of treatment
Incidence of antidrug antibodies (ADA)
The presence of ADAs to SIM0278 will be listed and summarized by treatment group
Measured: Part 1:up to 29 days after the first dose of treatment; Part 2:up to 85 days after the first dose of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start23 Aug 2023
- Primary completion18 Mar 2025
- Study completion22 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06022354
- Sponsor's protocol ID
- SIM0278-101
- Status last verified
- Jul 2025
- First submitted
- 15 Aug 2023
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Double-blind, Sponsor Open, Placebo-controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SIM0278 After Single and Multiple Subcutaneous Injections in Chinese Healthy Subjects
- ClinicalTrials.gov ID
- NCT06022354
- Acronym / sponsor ID
- SIM0278-101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 18 Mar 2025 (actual)
- Study completion
- 22 Jul 2025 (actual)
- First posted
- 1 Sep 2023 (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 1, randomized, double-blind, placebo-controlled trial of SIM0278 in healthy subjects. The study will be conducted in 2 parts. Part 1 is single ascending dose study. Part 2 is multiple ascending dose study.
Detailed description
The study will assess the safety, tolerability, and pharmacokinetics（PK） after a single or multiple administration of SIM0278 or placebo via subcutaneous injection in healthy subjects (male or female) where PK, pharmacodynamics (PD) and biomarkers will be assessed. Approximately 68 subjects (up to 84) will be enrolled in the whole study. The ratio of active drug to placebo in each dose level will be 3:1. In part1, approximately 44 subjects (up to 52) will be enrolled for the single dose escalation. Six dose levels are planned in part 1. In part2, approximately 24 (up to 32) subjects will be enrolled for the multiple dose escalation. Three dose levels are planned in part 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Part 1 : cohort 1: SIM0278 or placebo | Experimental | Drug: SIM0278 Injection/Placebo |
| Part 1 : cohort 2: SIM0278 or placebo | Experimental | Drug: SIM0278 Injection/Placebo |
| Part 1 : cohort 3: SIM0278 or placebo | Experimental | Drug: SIM0278 Injection/Placebo |
| Part 1 : cohort 4: SIM0278 or placebo | Experimental | Drug: SIM0278 Injection/Placebo |
| Part 1 : cohort 5: SIM0278 or placebo | Experimental | Drug: SIM0278 Injection/Placebo |
| Part 1 : cohort 6: SIM0278 or placebo | Experimental | Drug: SIM0278 Injection/Placebo |
| Part 1 : cohort 7: SIM0278 or placebo | Experimental | Drug: SIM0278 Injection/Placebo |
| Part 2 : cohort 1: SIM0278 or placebo | Experimental | Drug: SIM0278 Injection/Placebo |
| Part 2 : cohort 2: SIM0278 or placebo | Experimental | Drug: SIM0278 Injection/Placebo |
| Part 2 : cohort 3: SIM0278 or placebo | Experimental | Drug: SIM0278 Injection/Placebo |
| Part 2 : cohort 4: SIM0278 or placebo | Experimental | Drug: SIM0278 Injection/Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subject must be 18 to 55 years of age (inclusive), at the time of signing the informed consent.
- Body Mass Index (BMI) ≥ 18 and ≤ 28 kg/m2 and weight at least 45 kg at screening.
- A condition of general good health, as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, vital signs, laboratory profile, a 12-lead electrocardiogram (ECG) and chest X-ray.
- A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- A male subject must agree to use contraception as detailed in this protocol from screening through at least 90 days after the last dose of study drug. Sperm donation is also restricted during the time-frame that males must practice highly effective method of contraception. This criterion may be waived for male subjects who have had a vasectomy more than (>) 90 days prior to screening.
Key exclusion criteria (26 listed)
- History of significant sensitivity to any drug or previous severe adverse reaction to subcutaneous medication.
- Subject has a history of any clinically significant cardiac, respiratory (including asthma, bronchospasm), renal, hepatic, gastrointestinal, psychiatric, neurologic, hematologic or rheumatic disease, or psychiatric disease or disorder, current acute or chronic infections, or other abnormality that may affect safety, or potentially influence the study results, judged by the investigator.
- Chronic or active infection(s) requiring treatment with intravenous anti-infectives within 4 weeks prior to the dose of study drug, or oral anti-infectives within 2 weeks prior to Day 1, or positive test for novel coronavirus antigen or nucleic acid within 4 weeks prior to first dose
- Evidence or history of malignancy other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma.
- History of chronic or active hepatitis, or current positive result, including hepatitis B or hepatitis C infection, as evidenced by a positive test for hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab).
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 |
|---|---|---|
| SIM0278 Injection/PlaceboSIM0278 Injection/Placebo | Drug | Part 1 : cohort 1: SIM0278 or placebo, Part 1 : cohort 2: SIM0278 or placebo, Part 1 : cohort 3: SIM0278 or placebo, Part 1 : cohort 4: SIM0278 or placebo, Part 1 : cohort 5: SIM0278 or placebo, Part 1 : cohort 6: SIM0278 or placebo, Part 1 : cohort 7: SIM0278 or placebo, Part 2 : cohort 1: SIM0278 or placebo, Part 2 : cohort 2: SIM0278 or placebo, Part 2 : cohort 3: SIM0278 or placebo, Part 2 : cohort 4: SIM0278 or placebo |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) of subcutaneous injections of SIM0278 in healthy subjects after single dose (Part 1) or multiple dose (Part 2) administration
Time frame: Part 1:up to 29 days after the first dose of treatment; Part 2:up to 85 days after the first dose of treatment
7 secondary outcomes
Peak plasma concentration(Cmax) of SIM0278 in serum
Time frame: Time Frame: Part 1:up to 29 days after the first dose of treatment; Part 2:up to 57 days after the first dose of treatment
Time to reach maximum concentration (Tmax) of SIM0278 in serum
Time frame: Part 1:up to 29 days after the first dose of treatment; Part 2:up to 57 days after the first dose of treatment
Area under the curve (AUC) of SIM0278in serum
Time frame: Part 1:up to 29 days after the first dose of treatment; Part 2:up to 57 days after the first dose of treatment
Half life (T1/2) of SIM0278 in serum
Time frame: Part 1:up to 29 days after the first dose of treatment; Part 2:up to 57 days after the first dose of treatment
Total body clearance (CL/F) of SIM0278 in serum
Time frame: Part 1:up to 29 days after the first dose of treatment; Part 2:up to 57 days after the first dose of treatment
Total volume of distribution（Vd） at the terminal phase of SIM0278 in serum
Time frame: Part 1:up to 29 days after the first dose of treatment; Part 2:up to 57 days after the first dose of treatment
Incidence of antidrug antibodies (ADA)
Time frame: Part 1:up to 29 days after the first dose of treatment; Part 2:up to 85 days after the first dose of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
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 of Healthy Volunteers, 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 8 inclusion and 26 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: finished, as of the sponsor's last update on 11 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) of subcutaneous injections of SIM0278 in healthy subjects after single dose (Part 1) or multiple dose (Part 2) administration (time frame: Part 1:up to 29 days after the first dose of treatment; Part 2:up to 85 days after the first dose of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2025.