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

ConditionDermatitis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)/height² (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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHR-1894 Injection

    Drug

    SHR-1894 injection.

  • SHR-1894 Injection Placebo

    Drug

    SHR-1894 injection placebo.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: SHR-1894 Injection GroupExperimental treatment 1 intervention
Group B: SHR-1894 Injection Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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