This is a phase I study to evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of RC1416 injection via Subcutaneous Administration in Healthy Adult Volunteers.
RC1416 is a bispecific homodimer nanobody .It is being developed by Nanjing RegeneCore Biotech Co., Ltd. as a potential therapy for asthma. A total 48 healthy adult subjects will be enrolled in six groups to access the safety and tolerability of single subcutaneous injection of RC1416 in healthy adult subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
RC1416(SAD),there are six doses(25mg-600mg) in this part. Each subjects will receive the drug once by subcutaneous injection.
Placebo(SAD), Each subjects will receive the placebo once by subcutaneous injection.
China-japan Friendship Hospital
Beijing, Beijing Municipality, China
Adverse Events
incidence ,severity and relation to investigational drugs of Adverse Events according to CTCAE V5.0
Time frame: up to 92 days
Vital Signs
number of praticipants with clinically notable Vital Signs according to CTCAE V5.0
Time frame: up to 92 days
Laboratory Tests
number of praticipants with clinically notable Laboratory Tests according to CTCAE V5.0
Time frame: up to 92 days
ECG
number of praticipants with clinically notable Electrocardiogram(ECG) Values according to CTCAE V5.0
Time frame: up to 92 days
Injection Site Reaction
number of praticipants with clinically notable Injection Site Reaction according to CTCAE V5.0
Time frame: up to 4 days
Pharmacokinetics-Cmax
maximum serum concentration
Time frame: up to 92 days
Pharmacokinetics-AUC 0-t
area under the concentration-time curve (AUC) from administration to the last measurable concentration
Time frame: up to 92 days
Pharmacokinetics-AUC 0-inf
AUC extrapolated to infinitymeasurable concentration
Time frame: up to 92 days
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Anti-Drug antibody (ADA)
number and percentage of subjects tested ADA positive
Time frame: up to 92 days