This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered JMT202 in Healthy Participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
54
Peking University First Hospital
Beijin, China
The Number of adverse events (AEs) electrocardiograms
To investigate the safety and tolerability by assesment of AEs following administration.
Time frame: Pre-dose and multiple timepoints no less than 50 days
Number of participants with clinically significant change from baseline in vital signs
Time frame: Pre-dose and multiple timepoints no less than 50 days
Number of participants with clinically significant change from baseline in electrocardiogram (ECG) findings
Time frame: Pre-dose and multiple timepoints no less than 50 days
Number of participants with clinically significant abnormalities in physical examination
Time frame: Pre-dose and multiple timepoints no less than 50 days
Area under the concentration-time curve from 0 to the collection time t (AUC0-t)
Time frame: Pre-dose and multiple timepoints no less than 50 days
Area under the concentration-time curve from 0 to infinity (AUC0-∞)
Time frame: Pre-dose and multiple timepoints no less than 50 days
Time to maximum concentration (Tmax)
Time frame: Pre-dose and multiple timepoints no less than 50 days
Serum Maximum concentration (Cmax)
Time frame: Pre-dose and multiple timepoints no less than 50 days
Half-Life (t1/2)
Time frame: Pre-dose and multiple timepoints no less than 50 days
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Anti-drug antibody (ADA) prevalence in blood before study treatment and at the Follow-up Visit
Time frame: Pre-dose and multiple timepoints no less than 50 days
Absolute change in High molecular weight adiponectin
Time frame: Pre-dose and multiple timepoints no less than 50 days
Absolute change in weight
Time frame: Pre-dose and multiple timepoints no less than 50 days
Absolute change in glycosylated hemoglobin
Time frame: Pre-dose and multiple timepoints no less than 50 days
Absolute change in fasting insulin level
Time frame: Pre-dose and multiple timepoints no less than 50 days
Absolute change in fasting glucose
Time frame: Pre-dose and multiple timepoints no less than 50 days
Absolute change in blood lipoprotein
Time frame: Pre-dose and multiple timepoints no less than 50 days