Safety, Tolerability, PK and PD of SSS55 in Healthy Subjects
ConditionSafety Issues
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorShenyang Sunshine Pharmaceutical Co., LTD.
About this trial
This study was a single-dose, randomized, double-blind, placebo-controlled study of SSS55 injection to evaluate the safety, tolerability, PK characteristics, immunogenicity and preliminary efficacy characteristics of single-dose SSS55 injection in healthy individuals.
Eligibility criteria
Qualifiers
Healthy subjects aged 18 to 45 years old (including the boundary value), regardless of gender;
The subjects voluntarily participated in the clinical trial and signed the informed consent form;
Men with a weight of ≥50 kg, women with a weight of ≥45 kg, and those with a body mass index (BMI) ranging from 19 to 28 kg/m2 (including the critical value);
Those who underwent vital sign assessment, physical examination, blood routine, urine routine, blood biochemistry, coagulation function, pregnancy examination (for women of childbearing age), 12-lead ECG, chest X-ray/lung CT during screening, and the results showed no abnormalities or the abnormalities had no clinical significance;
Disqualifiers
1) Those with a clear history of drug or food allergies, or a known history of hypersensitivity reactions that are clinically significant to the research intervention measures or related compounds or commonly used antibacterial agents;
Trial design
Treatments tested in this trial
- SSS55
Treatment groups
26 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov