ClinicalTrials.gg
RecruitingNCT07414602Updated Mar 18, 2026

A Phase I Study of Single Subcutaneous Dose of SHR-1894 in Healthy Subjects

A Phase 1 interventional study of SHR-1894 Injection and SHR-1894 Injection Placebo in Dermatitis, sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-18.

Sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd. (part of Jiangsu HengRui Medicine Co., Ltd.) · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

The Phase I clinical study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-1894 in healthy subjects.

02

Conditions studied

  • Dermatitis

Browse trials for

03

In context

Dermatitis

238 studies on the registry are indexed under Dermatitis; 34 are open to participants now.

This study's planned enrollment of 40 is below the median of 68 across 191 interventional studies indexed under Dermatitis.

Browse Dermatitis studies →

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd. is the lead sponsor of 104 studies on the registry; 73 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. The subject has voluntarily provided written , fully understands the purpose and significance of this trial, and is willing to comply with the study protocol.
  2. Healthy male or female subjects, aged 18 to 45 years (inclusive) at the time of signing the informed consent form.
  3. Body weight ≥ 50 kg for males and ≥ 45 kg for females. (BMI) = weight (kg)/height\^2 (m²). BMI between 19 and 26 kg/m², inclusive.
  4. Subjects with no abnormalities, or only minor abnormalities deemed clinically insignificant by the investigator, in physical examination, vital signs, 12-lead (ECG), posteroanterior and lateral chest radiographs, abdominal ultrasound, and laboratory tests during the screening and baseline periods.
  5. Female subjects of and male subjects with partners of childbearing age must have been using highly effective 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.

Exclusion criteria

Exclusion Criteria:

  1. Subjects with a history or current diagnosis of any disease, as determined by the investigator, involving the urinary, circulatory, endocrine, neurological, digestive, respiratory, hematopoietic, immune systems, or psychiatric and metabolic disorders.
  2. Subjects who, in the investigator's judgment, have any condition or disease that may affect the absorption, metabolism, and/or excretion of the drug.
  3. 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.
  4. Subjects with a known allergy to the investigational drug or any of its components, or with a history of atopy (e.g., asthma, eczema).
  5. 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.
  6. 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 is longer).
  7. Female subjects who are pregnant, breastfeeding, or have a positive pregnancy test result at screening or baseline.
  8. 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.
  9. Subjects who have received any vaccination within 2 weeks prior to screening or who plan to receive any vaccination during the trial.
  10. 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.
  11. 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.
  12. Subjects with a history of illicit drug use or substance abuse/dependence prior to screening; or a positive urine drug test at baseline.
  13. Subjects with special dietary requirements that prevent compliance with the standardized diet.
  14. Subjects with difficult venous access or whose physical condition cannot tolerate frequent blood sampling.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    SHR-1894 Injection Group

    SHR-1894 injection, in different doses.

    Drug: SHR-1894 Injection

  • Placebo comparator
    SHR-1894 Injection Placebo Group

    SHR-1894 injection placebo.

    Drug: SHR-1894 Injection Placebo

Interventions

  • DrugSHR-1894 Injection

    SHR-1894 injection.

  • DrugSHR-1894 Injection Placebo

    SHR-1894 injection placebo.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to Day 85.

Secondary outcomes

  1. Concentrations of SHR-1894 in serum following single subcutaneous administration

    Pharmacokinetics (PK) endpoint.

    Time frame: Up to Day 85.

  2. Maximum observed plasma concentration of SHR-1894 (Cmax)

    Pharmacokinetic parameters of SHR-1894 following single subcutaneous administration.

    Time frame: Up to Day 85.

  3. Time to Cmax (Tmax)

    Pharmacokinetic parameters of SHR-1894 following single subcutaneous administration.

    Time frame: Up to Day 85.

  4. 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.

    Time frame: Up to Day 85.

  5. 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.

    Time frame: Up to Day 85.

  6. Apparent clearance of SHR-1894 (CL/F)

    Pharmacokinetic parameters of SHR-1894 following single subcutaneous administration.

    Time frame: Up to Day 85.

  7. Apparent volume of distribution of SHR-1894 (Vz/F)

    Pharmacokinetic parameters of SHR-1894 following single subcutaneous administration.

    Time frame: Up to Day 85.

  8. Terminal elimination half-life of SHR-1894 (t1/2)

    Pharmacokinetic parameters of SHR-1894 following single subcutaneous administration.

    Time frame: Up to Day 85.

  9. Incidence of Anti-drug Antibodies (ADA)

    Including positive rate and duration.

    Time frame: Up to Day 85.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Oct 2026, 7 months after the start.

Of 13 phase 1 interventional studies under Dermatitis, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 24. This study's planned 7 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 3, 2026
First posted
Feb 17, 2026
StartActual
Mar 16, 2026
Primary completionEst.
Oct 2026
CompletionEst.
Dec 2026
Last update
Mar 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07414602
Responsible party
Sponsor
First posted
Feb 17, 2026
Start date
Mar 16, 2026
Primary completion
Oct 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Mar 18, 2026

Study contacts

Ruifang Guan
Contact
ruifang.guan.rg1@hengrui.com
+86-0518-81220121

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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