Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • SSS55

    Drug

    SSS55 is an injection targeting complement C3b

Treatment groups

26 Participants
are divided into 4 treatment groups
Group A: Low-dose groupExperimental treatment 1 intervention
Group B: middle-dose groupExperimental treatment 1 intervention
Group C: high-dose groupExperimental treatment 1 intervention
Group D: Higher-dose groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To evaluate the safety and tolerability of a single intravenous infusion of SSS55 injection in healthy adult subjects in China

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time frame
22days

Secondary outcomes

1

To evaluate the pharmacokinetic (PK) characteristics of SSS55 injection after a single intravenous infusion in healthy adult subjects in China

To evaluate the AUC of SSS55 injection

Time frame
22days
2

To evaluate the pharmacodynamic characteristics of SSS55 injection after a single intravenous infusion in healthy adult subjects in China

To evaluate the complement3 of SSS55 injection

Time frame
22 days
3

To evaluate the ADA of SSS55 injection after a single intravenous infusion in healthy adult subjects in China

To evaluate the ADA of SSS55 injection

Time frame
22days

Other outcomes

Sponsors and contacts

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

Shenyang Sunshine Pharmaceutical Co., LTD.

Lead sponsor

Source ClinicalTrials.gov
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