DermatitisPhase 1NCT07414602
A Phase I Study of Single Subcutaneous Dose of SHR-1894 in Healthy Subjects
A Phase 1 study testing SHR-1894 Injection in people with Dermatitis, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
The Phase I clinical study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-1894 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatitis
- What is being tested?
- SHR-1894 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 16 Mar 2026to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject has voluntarily provided written informed consent, fully understands the purpose and significance of this trial, and is willing to comply with the study protocol.
- Healthy male or female subjects, aged 18 to 45 years (inclusive) at the time of signing the informed consent form.
- Body weight ≥ 50 kg for males and ≥ 45 kg for females. Body mass index (BMI) = weight (kg)/height^2 (m²). BMI between 19 and 26 kg/m², inclusive.
- Subjects with no abnormalities, or only minor abnormalities deemed clinically insignificant by the investigator, in physical examination, vital signs, 12-lead electrocardiogram (ECG), posteroanterior and lateral chest radiographs, abdominal ultrasound, and laboratory tests during the screening and baseline periods.
- Female subjects of childbearing potential and male subjects with partners of childbearing age must have been using highly effective contraception for at least 2 weeks prior to signing the informed consent form. They must be willing to either abstain from sexual intercourse or agree to continue using highly effective contraception from the time of signing the informed consent until the end of the follow-up period, and must have no plans for conception or donation of sperm/ova.
Who cannot join
- Subjects with a history or current diagnosis of any clinically significant disease, as determined by the investigator, involving the urinary, circulatory, endocrine, neurological, digestive, respiratory, hematopoietic, immune systems, or psychiatric and metabolic disorders.
- Subjects who, in the investigator's judgment, have any condition or disease that may affect the absorption, metabolism, and/or excretion of the investigational drug.
- Subjects who have experienced severe infection, severe trauma, or undergone major surgery within 1 month prior to the screening period; or who plan to undergo surgery during the trial period.
- Subjects with a known allergy to the investigational drug or any of its components, or with a history of atopy (e.g., asthma, eczema).
- Subjects will be excluded if they meet any of the following criteria: Use of any medication (including prescription drugs, over-the-counter medications, Chinese herbal medicines, dietary supplements, and vitamin A and its derivatives, with the exception of other routine vitamins and occasional use of acetaminophen) within 2 weeks prior to screening.Any medication taken within 5 half-lives prior to screening (whichever period is longer).Planned use of any non-study medication during the trial period.
- Subjects will be excluded for any of the following: Participation in any other drug or medical device clinical trial within 3 months prior to screening or planned participation during the study period.Any prior investigational drug taken within 5 half-lives prior to screening (whichever washout period is longer).
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- Female subjects who are pregnant, breastfeeding, or have a positive pregnancy test result at screening or baseline.
- Subjects with a history of blood donation (≥ 400 mL) or significant blood loss within 8 weeks prior to screening, or who received a blood transfusion within 4 weeks prior to screening or baseline; or who intend to donate blood during the trial period.
- Subjects who have received any vaccination within 2 weeks prior to screening or who plan to receive any vaccination during the trial.
- Subjects with a history of significant smoking (averaging >5 cigarettes per day) within 4 weeks prior to screening, or who are unable to abstain from using any tobacco products during the trial period.
- Subjects meeting any of the following criteria will be excluded: Average daily alcohol intake exceeding 15 g (equivalent to 450 mL of beer, 150 mL of wine, or approximately 50 mL of low-alcohol spirits) within 4 weeks prior to screening.Inability to abstain from alcohol consumption during the trial period.A positive alcohol breath test at baseline.
- Subjects with a history of illicit drug use or substance abuse/dependence prior to screening; or a positive urine drug test at baseline.
- Subjects with special dietary requirements that prevent compliance with the standardized diet.
- Subjects with difficult venous access or whose physical condition cannot tolerate frequent blood sampling.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Ping Feng, +86-028-85423583, 617130961@qq.com
Ping Feng
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous Doses of SHR-1894 in Healthy Subjects
The Phase I clinical study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-1894 in healthy subjects.
- Conditions
- Dermatitis
- Being tested
- SHR-1894 Injection, SHR-1894 Injection Placebo
- Medical subject headings
- Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1894 InjectionDrug
SHR-1894 injection.
SHR-1894 Injection PlaceboDrug
SHR-1894 injection placebo.
| Study group | Role | What they receive |
|---|---|---|
| SHR-1894 Injection Group | Experimental | SHR-1894 injection, in different doses. Receives: Drug: SHR-1894 Injection |
| SHR-1894 Injection Placebo Group | Placebo comparator | SHR-1894 injection placebo. Receives: Drug: SHR-1894 Injection Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any changes in adverse events (AEs)
Safety and tolerability, including any changes in adverse events (AEs), 12-lead electrocardiograms (ECGs), vital signs, physical examinations, laboratory findings, and other relevant parameters.
Measured: Up to Day 85.
Secondary outcomes (9)
Concentrations of SHR-1894 in serum following single subcutaneous administration
Pharmacokinetics (PK) endpoint.
Measured: Up to Day 85.
Maximum observed plasma concentration of SHR-1894 (Cmax)
Pharmacokinetic parameters of SHR-1894 following single subcutaneous administration.
Measured: Up to Day 85.
Time to Cmax (Tmax)
Pharmacokinetic parameters of SHR-1894 following single subcutaneous administration.
Measured: Up to Day 85.
Area under the concentration-time curve from 0 to the last measurable time point after SHR-1894 administration (AUC0-t)
Pharmacokinetic parameters of SHR-1894 following single subcutaneous administration.
Measured: Up to Day 85.
Area under the concentration-time curve from time 0 to infinity after SHR-1894 administration (AUC0-inf)
Pharmacokinetic parameters of SHR-1894 following single subcutaneous administration.
Measured: Up to Day 85.
Apparent clearance of SHR-1894 (CL/F)
Pharmacokinetic parameters of SHR-1894 following single subcutaneous administration.
Measured: Up to Day 85.
Apparent volume of distribution of SHR-1894 (Vz/F)
Pharmacokinetic parameters of SHR-1894 following single subcutaneous administration.
Measured: Up to Day 85.
Terminal elimination half-life of SHR-1894 (t1/2)
Pharmacokinetic parameters of SHR-1894 following single subcutaneous administration.
Measured: Up to Day 85.
Incidence of Anti-drug Antibodies (ADA)
Including positive rate and duration.
Measured: Up to Day 85.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start16 Mar 2026
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatitisStudies of the same condition, open and under way.
- More trials run by Suzhou Suncadia Biopharmaceuticals 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
- Model description
- A randomized, double-blind, placebo-controlled study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414602
- Sponsor's protocol ID
- SHR-1894-101
- Status last verified
- Mar 2026
- First submitted
- 3 Feb 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous Doses of SHR-1894 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07414602
- Acronym / sponsor ID
- SHR-1894-101
- Conditions
- Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Feb 2026 (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.
The Phase I clinical study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-1894 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, double-blind, placebo-controlled study.
| Arm | Type | Receives |
|---|---|---|
| SHR-1894 Injection Group | Experimental | Drug: SHR-1894 InjectionSHR-1894 injection, in different doses. |
| SHR-1894 Injection Placebo Group | Placebo comparator | Drug: SHR-1894 Injection PlaceboSHR-1894 injection placebo. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The subject has voluntarily provided written informed consent, fully understands the purpose and significance of this trial, and is willing to comply with the study protocol.
- Healthy male or female subjects, aged 18 to 45 years (inclusive) at the time of signing the informed consent form.
- Body weight ≥ 50 kg for males and ≥ 45 kg for females. Body mass index (BMI) = weight (kg)/height^2 (m²). BMI between 19 and 26 kg/m², inclusive.
- Subjects with no abnormalities, or only minor abnormalities deemed clinically insignificant by the investigator, in physical examination, vital signs, 12-lead electrocardiogram (ECG), posteroanterior and lateral chest radiographs, abdominal ultrasound, and laboratory tests during the screening and baseline periods.
- Female subjects of childbearing potential and male subjects with partners of childbearing age must have been using highly effective contraception for at least 2 weeks prior to signing the informed consent form. They must be willing to either abstain from sexual intercourse or agree to continue using highly effective contraception from the time of signing the informed consent until the end of the follow-up period, and must have no plans for conception or donation of sperm/ova.
Key exclusion criteria (14 listed)
- Subjects with a history or current diagnosis of any clinically significant disease, as determined by the investigator, involving the urinary, circulatory, endocrine, neurological, digestive, respiratory, hematopoietic, immune systems, or psychiatric and metabolic disorders.
- Subjects who, in the investigator's judgment, have any condition or disease that may affect the absorption, metabolism, and/or excretion of the investigational drug.
- Subjects who have experienced severe infection, severe trauma, or undergone major surgery within 1 month prior to the screening period; or who plan to undergo surgery during the trial period.
- Subjects with a known allergy to the investigational drug or any of its components, or with a history of atopy (e.g., asthma, eczema).
- Subjects will be excluded if they meet any of the following criteria: Use of any medication (including prescription drugs, over-the-counter medications, Chinese herbal medicines, dietary supplements, and vitamin A and its derivatives, with the exception of other routine vitamins and occasional use of acetaminophen) within 2 weeks prior to screening.Any medication taken within 5 half-lives prior to screening (whichever period is longer).Planned use of any non-study medication during the trial period.
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 |
|---|---|---|
| SHR-1894 InjectionSHR-1894 injection. | Drug | SHR-1894 Injection Group |
| SHR-1894 Injection PlaceboSHR-1894 injection placebo. | Drug | SHR-1894 Injection Placebo Group |
Primary outcome
Any changes in adverse events (AEs)
Time frame: Up to Day 85.
Safety and tolerability, including any changes in adverse events (AEs), 12-lead electrocardiograms (ECGs), vital signs, physical examinations, laboratory findings, and other relevant parameters.
9 secondary outcomes
Concentrations of SHR-1894 in serum following single subcutaneous administration
Time frame: Up to Day 85.
Maximum observed plasma concentration of SHR-1894 (Cmax)
Time frame: Up to Day 85.
Time to Cmax (Tmax)
Time frame: Up to Day 85.
Area under the concentration-time curve from 0 to the last measurable time point after SHR-1894 administration (AUC0-t)
Time frame: Up to Day 85.
Area under the concentration-time curve from time 0 to infinity after SHR-1894 administration (AUC0-inf)
Time frame: Up to Day 85.
Apparent clearance of SHR-1894 (CL/F)
Time frame: Up to Day 85.
Apparent volume of distribution of SHR-1894 (Vz/F)
Time frame: Up to Day 85.
Terminal elimination half-life of SHR-1894 (t1/2)
Time frame: Up to Day 85.
Incidence of Anti-drug Antibodies (ADA)
Time frame: Up to Day 85.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 SHR-1894 Injection in people with Dermatitis, run by Suzhou Suncadia Biopharmaceuticals 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 5 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 18 Mar 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruifang Guan (+86-0518-81220121, ruifang.guan.rg1@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any changes in adverse events (AEs) (time frame: Up to Day 85.). 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 18 Mar 2026.