Primary purpose: To evaluate the safety and tolerability of KLA480 injection after a single subcutaneous injection in healthy participants. Secondary purpose: To evaluate the pharmacokinetic (PK) characteristics of KLA480 injection after a single subcutaneous injection in healthy participants.
This study was a single-center, randomized, double-blind, placebo-controlled, dose Escalation, phase I clinical study to evaluate the safety, tolerability and pharmacokinetic characteristics of KLA480 injection after a single subcutaneous injection in healthy Chinese participants. The plan is to enroll 20 healthy participants in two dose groups: Group I (11.3 mg) and Group II (22.6 mg). Each dose group will includ 10 participants (at least 3 single-sex participants). Among them, 8 participants received the experimental drug KLA480 injection, and 2 participants received the placebo KLA480 injection simulator. Participants in different dose groups were successively enrolled. Based on the evaluation of acceptable tolerance and safety of participants in the former dose group, the researchers will discuss with the sponsor whether to carry out the next dose group. The "sentinel" method was used in each dose group, that is, 3 participants were enrolled in each dose group first, of which 2 participants received KLA480 injection, and 1 participant received placebo KLA480 injection simulator. Tolerance assessment will be performed 48 h after administration of the first 3 participants, and if the tolerance evaluation is acceptable, the remaining 7 participants in the current dose group will be enrolled (6 receiving the experimental drug and 1 receiving placebo).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
Subcutaneous injection,Single dose
Subcutaneous injection,Single dose
Huashan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGSafety and tolerability
Safety and tolerability was assessed by the number of participants with adverse events (AE).
Time frame: Collected from signing of informed consent until 43 days after a single dose.
Maximum peak plasma concentration (Cmax) [Pharmacokinetics]
Samples will also be collected until 43 days after a single dose(samples will be collected in the morning). PK parameters will be assessed for plasma brexpiprazole and its metabolite(s) .
Time frame: 43 days after a single dose.
Time of Cmax (tmax) [Pharmacokinetics]
Samples will also be collected until 43 days after a single dose(samples will be collected in the morning). PK parameters will be assessed for plasma brexpiprazole and its metabolite(s) .
Time frame: 43 days after a single dose.
Area under the concentration-time curve (AUC) from time zero to time "t" [Pharmacokinetics]
Samples will also be collected until 43 days after a single dose(samples will be collected in the morning). PK parameters will be assessed for plasma brexpiprazole and its metabolite(s) .
Time frame: 43 days after a single dose.
AUC from time zero to infinity (AUC∞) [Pharmacokinetics]
Samples will also be collected until 43 days after a single dose(samples will be collected in the morning). PK parameters will be assessed for plasma brexpiprazole and its metabolite(s) .
Time frame: 43 days after a single dose.
Terminal-phase elimination half-life (t1/2,z) [Pharmacokinetics]
Samples will also be collected until 43 days after a single dose(samples will be collected in the morning). PK parameters will be assessed for plasma brexpiprazole and its metabolite(s) .
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Time frame: 90 days after a single dose.