The study consists of two parts: dose escalation and expansion. It includes five cohorts in the dose-escalation phase and two expansion cohorts based on pharmacokinetic data.
This study is a Phase I clinical trial that is randomized, double-blind, placebo-controlled, and involves single-dose administration, dose-escalation, and an expansion phase. It evaluates the safety, tolerability, and pharmacokinetic profile of AK0610 in healthy Chinese adults. The study consists of two parts. The dose-escalation phase includes five cohorts (100 mg i.m.; 300 mg i.m.; 300 mg i.v.; 1000 mg i.v.; 3000 mg i.v.), each consisting of 8 individuals (AK0610: Placebo = 3:1), who are administered doses in sequential increments. Based on pharmacokinetic data, the dose-escalation phase will be expanded to include two additional dose cohorts (300 mg i.m.; 600 mg i.m.) of 48 individuals each (AK0610: Placebo = 3:1). Each participant will undergo a Screening Period from Day -29 to Day -1. They will receive one dose on Day 1, an Inpatient Observation Period from Day -1 to Day 8, and a Blinded Follow-Up Period from Day 9 to Day 181. Subjects in the AK0610 group will also enter an open-label period from Day 182 to Day 361.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
136
Active Substance: AK0610 Pharmaceutical Form: Injection solution Route of Administration: Intramuscular injection or intravenous injection.
Active Substance: Placebo Pharmaceutical Form: Injection Route of Administration: Intramuscular injection or intravenous injection
The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital )
Jinan, Shandong, China
RECRUITINGIncidence and severity of treatment-emergent adverse events (TEAEs)
Capture the incidence and severity of adverse events using CTCAE v5.0, documenting all treatment-emergent adverse events (TEAEs) throughout the study period.
Time frame: Up to 361 days
Maximum Observed Serum Concentration (Cmax) of AK0610
The Cmax is the maximum observed serum concentration of AK0610.
Time frame: Up to 361 days
Time to Reach Maximum Observed Serum Concentration (Tmax) of AK0610
The Tmax is defined as time at which maximum observed concentration of AK0610 (Cmax) was observed.
Time frame: Up to 361 days
Area Under the serum concentration-time curve from time 0 to the last measurable concentration (AUC₀-t) of AK0610
It represents the area under the curve of serum concentration versus time for the drug AK0610 from the time of administration until the last measurable concentration.
Time frame: Up to 361 days
Area Under the serum concentration-time curve from time 0 to extrapolated to infinite time (AUC (0-infinity) ) of AK0610
The pharmacokinetic (PK) parameter AUC (0-infinity) was estimated based on the serum concentrations of AK0610.
Time frame: Up to 361 days
Terminal Elimination Half Life (t1/2) of AK0610
Terminal phase elimination half-life (t1/2) is the time required for half of the drug to be eliminated from the serum.
Time frame: Up to 361 days
Extravascular Clearance (CL/F (intramuscular administration)) of AK0610
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.
Time frame: Up to 361 days
Apparent Volume of Distribution (Vd/F (intramuscular administration)) of AK0610
It represents the theoretical volume in which the drug is distributed in the body, calculated by dividing the dose by the concentration in the terminal elimination phase.
Time frame: Up to 361 days
CL(IV administration) of AK0610
Clearance (CL) following intravenous administration will be calculated to quantify the rate of drug elimination from plasma.
Time frame: Up to 361 days
Vd (IV administration) of AK0610
Volume of distribution (Vd) after intravenous dosing will be estimated to characterize the drug's tissue penetration relative to plasma
Time frame: Up to 361 days
To assess the changes in serum RSV-neutralizing activity after a single intramuscular or intravenous injection of AK0610 in healthy Chinese subjects
Changes in serum anti-RSV neutralizing antibody titers
Time frame: Up to 361 days
To assess the immunogenicity of a single intramuscular or intravenous injection of AK0610 in healthy Chinese subjects.
Serum positivity and titer of anti-drug antibodies against AK0610
Time frame: Up to 361 days