The goal of this clinical trial is to learn if a single dose of the study drug, JST-018, is safe and tolerable when administered by injection into the arm or thigh muscle of healthy men and women aged 18 to 55. The main questions it aims to answer are: * Is a single administration of JST-018 safe? * What is the concentration of the JST-018 in the blood over time? * Do antibodies to JST-018 develop following a dose of JST-018? Researchers will compare JST-018 to Placebo to see if there are any differences in the safety and tolerability of a single dose at different dose levels. Participants will be confined to the clinic for the first 3 days. They will receive an injection on the second day, and then return for 9 more visits over the period of 1 year for: * Physical exam with vital signs * Electro-cardiogram (ECG) * Bood collection for clinical labs and research samples * Urine sample * Assessment of potential adverse effects and medications taken
This is a Phase 1, first-in-human (FIH), randomized, double-blind, placebo-controlled, single ascending dose (SAD) study to assess the safety, tolerability, and PK of a single dose of JST-018 administered IM to healthy participants. The study will be comprised of a minimum of 3 cohorts (Cohorts A, B, and C, with 12 participants per cohort), each evaluating a single dose of JST-018 administered IM. In each cohort, 2 sentinel participants will be randomized 1:1 such that one participant receives JST-018 and 1 participant receives placebo. Following a favorable blinded safety review committee (SRC) review of sentinel safety data collected through Day 8, the remainder of the cohort (10 non-sentinel participants) will be randomized 4:1 to JST-018 or placebo, and will be dosed. All safety data for all participants in the current cohort through Day 8 will be reviewed by the SRC in a blinded fashion for each dose cohort before escalating to the next dose cohort (for escalation from Cohort A to Cohort B and escalation from Cohort B to Cohort C); A recommendation on whether to implement Cohort D (along with a recommended dose of JST-018 to be evaluated in Cohort D) may be provided by the SRC following review of blinded safety data from Cohorts A, B, and C.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
48
Monoclonal antibodies
Placebo Comparator
PPD Las Vegas Clinical Research Unit
Las Vegas, Nevada, United States
RECRUITINGSafety and tolerability of of JST-018 administered intramuscularly (IM)
Incidence of solicited local (injection site) and systemic AEs post-injection through Day 7 (with the inpatient and outpatient participant diaries being collected on Day 3 and Day 8, respectively)
Time frame: From injection to Day 7
Safety and tolerability of of JST-018 administered IM
Incidence of unsolicited AEs through end of study (EOS)
Time frame: From injection to final visit at Week 48
Safety and tolerability of of JST-018 administered IM
Incidence of SAEs, medically attended AEs (MAAEs), and AEs of special interest (AESIs)
Time frame: From injection to final visit at Week 48
Safety and tolerability of of JST-018 administered IM
Incidence of Clinically Significant Changes in Laboratory Values
Time frame: From injection to final visit at Week 48
Safety and tolerability of JST-018 administered as IM
Incidence of Clinically Significant Changes in Vital Sign Measurements
Time frame: From injection to final visit at Week 48
Safety and tolerability of JST-018 administered as IM
Incidence of Clinically Significant Changes in ECG results
Time frame: From injection to final visit at Week 48
Pharmacokinetic Cmax of JST-018
Maximum observed concentration (Cmax)
Time frame: From enrollment to the end of study at 48 weeks
Pharmacokinetic Tmax of JST-018
Time to reach maximum observed concentration (Tmax)
Time frame: Time Frame: From enrollment to the end of study at 48 weeks
Pharmacokinetic Tlast of JST-018
The timepoint with the last quantifiable concentration (Tlast)
Time frame: From enrollment to the end of study at 48 weeks
Pharmacokinetic AUC0-t of JST-018
Area under the concentration versus time curve (AUC) from time 0 to the timepoint with the last quantifiable concentration (AUC0-t)
Time frame: From enrollment to the end of study at 48 weeks
Pharmacokinetic AUC0-inf of JST-018
AUC from time 0 extrapolated to infinity (AUC0-inf)
Time frame: From enrollment to the end of study at 48 weeks
Pharmacokinetic t1/2 of JST-018
Terminal elimination half-life (t1/2)
Time frame: From enrollment to the end of study at 48 weeks
Pharmacokinetic CL/F of JST-018
Apparent clearance after IM administration (CL/F)
Time frame: From enrollment to the end of study at 48 weeks
Pharmacokinetic Vz/F of JST-018
Apparent volume of distribution after IM administration (Vz/F)
Time frame: From enrollment to the end of study at 48 weeks
Evaluation the effect of anti-drug antibodies (ADA)
Effect of ADAs on pharmacokinetics of JST-018
Time frame: From enrollment to the end of study at 48 weeks
Evaluate if and to what extent ADAs develop following a single dose of JST-018
Proportion of participants with pre-existing ADAs and those who develop ADAs (treatment boosted and treatment induced) to JST-018
Time frame: From enrollment to the end of study at 48 weeks
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