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
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
Treatments tested in this trial
- SHR-1894 Injection
- SHR-1894 Injection Placebo
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov