This is a randomized, double-blind, placebo-controlled, single ascending dose phase I clinical study to evaluate the safety, tolerability, PK, PD and immunogenicity of SSS68 in healthy adult participants following a single subcutaneous administration.
This is the first-in-human (FIH) clinical study of SSS68. Seven dose groups are planned for dose escalation in this study: 2 mg, 50 mg, 200 mg, 400 mg, 600 mg, 900 mg and 1200 mg. The study will be conducted sequentially from low dose to high dose. Participants in all dose groups will receive a single subcutaneous injection. The study consists of a screening period (no more than 4 weeks), a single-dose administration period (Day1), and a follow-up period (Day2 to Day113), with duration of approximately 20 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
50
Huashan Hospital of Fudan University
Shanghai, China
Overall Summary of Treatment Emergent Adverse Events
The number of adverse events (AEs), serious adverse events (SAEs), and drug related adverse events following administration of SSS68.
Time frame: Baseline to day 113
Maximum Observed Serum Concentration (Cmax)
The Cmax is the maximum observed serum concentration.
Time frame: 0, 2, 6, and 12 hours post-dose, Day 2, 3, 4, 6, 8, 15, 22, 29, 43, 57, 85, and 113
Time to Reach Maximum Observed Serum Concentration (Tmax)
The Tmax is the time correspondent to the maximum observed serum concentration.
Time frame: 0, 2, 6, and 12 hours post-dose, Day 2, 3, 4, 6, 8, 15, 22, 29, 43, 57, 85, and 113
Terminal half-life (t1/2)
The t1/2 is the time measured for the serum concentration to decrease by 1 half to its original concentration.
Time frame: 0, 2, 6, and 12 hours post-dose, Day 2, 3, 4, 6, 8, 15, 22, 29, 43, 57, 85, and 113
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-t])
The AUC(0-t) is the area under the serum concentration-time curve from time 0 to last quantifiable concentration.
Time frame: 0, 2, 6, and 12 hours post-dose, Day 2, 3, 4, 6, 8, 15, 22, 29, 43, 57, 85, and 113
Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-inf])
The AUC(0-inf) is the area under the serum concentration-time curve from time zero to infinite time.
Time frame: 0, 2, 6, and 12 hours post-dose, Day 2, 3, 4, 6, 8, 15, 22, 29, 43, 57, 85, and 113
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Apparent Total Systemic Clearance (CL/F)
The CL/F is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Time frame: 0, 2, 6, and 12 hours post-dose, Day 2, 3, 4, 6, 8, 15, 22, 29, 43, 57, 85, and 113
Apparent Volume of Distribution (Vz/F)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. The Vz/F after subcutaneous dose is influenced by the fraction absorbed.
Time frame: 0, 2, 6, and 12 hours post-dose, Day 2, 3, 4, 6, 8, 15, 22, 29, 43, 57, 85, and 113
Immunogenicity
The number of participants with antibodies to SSS68.
Time frame: Day 0, 15, 29, 57, and 113