This study is a randomized, double-blind, placebo/positive control Phase Ia clinical trial evaluating the safety, tolerability, and pharmacokinetics of SIBP-A16 injection in healthy adults
This study plans to set up 5 queues, with queues 1, 3, 4, and 5 each containing 20 participants in the experimental group and 4 participants in the placebo group. Queue 2 contains 20 participants in the experimental group, 20 participants in the positive control group, and 4 participants in the placebo group. The total number of participants included in the five queues is 140. SIBP-A16 injection and placebo will be administered in four different doses and two different ways of administration. The study adopted a sequential injection design. After completing a 14-day preliminary safety observation of drug administration in the previous group, the Safety Review Committee (SRC) will conduct a preliminary safety assessment. Once the SRC evaluation results are safe (not meeting the dose escalation termination criteria), the next group will be enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
140
Single administration via intramuscular or intravenous injection. All participants received a single injection of the corresponding dose.
Single administration via intramuscular.
Single administration via intramuscular or intravenous injection. All participants received a single injection of the corresponding dose.
Wuhan Jinyintan Hospital
Wuhan, China
RECRUITINGAE (Adverse Events)
That is adverse events, any adverse events that occurred to the participant during the study period.
Time frame: From day 1 to day 361 after administration
SAE (Serious Adverse Events)
That is serious adverse events, any serious adverse events that occurred to the participant during the study period.
Time frame: From day 1 to day 361 after administration
Adverse Event of Special Interest (AESI)
Adverse events defined in the protocol that require special attention, such as abnormal liver function, etc.
Time frame: From day 1 to day 361 after administration
AUC (Area Under The Plasma Concentration Versus Time Curve)
It shows the degree to which a drug is absorbed and used in the body.
Time frame: Based on multiple pharmacokinetic blood collection points specified in the protocol
Cmax (Peak Plasma Concentration)
It shows the highest plasma concentration of a drug that can be achieved after administration.
Time frame: Based on multiple pharmacokinetic blood collection points specified in the protocol
Tmax (Peak Time)
That is peak time of drug action, it shows the time required to reach the maximum concentration on the participant plasma concentration curve after administration.
Time frame: Based on multiple pharmacokinetic blood collection points specified in the protocol
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