Phase I Study of JY1001 Injection
ConditionPain After Surgery
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorJemincare
About this trial
The goal of this dose esclation study is to evaluate the safety, tolerability, and PK characteristicsafter of a single dose of JY1001 injection in healthy participants. A total of 6 cohorts are planned to be evaluated. Each cohort will enroll 8 participants to receive JY1001 or placebo in 3:1 ratio.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy male or female adult participants
Men ≥50kg, women ≥45kg, and body mass index (BMI) 19-28 kg/m² (inclusive)
Disqualifiers
With any disease that the investigator judges will take risk to participants or affect the evaluation of the study.
Trial design
Design model
Sequential
Treatments tested in this trial
JY1001
DrugParticipants will receive a single dose of JY1001 (10 mg, 20 mg, 40 mg, 80 mg, 160 mg, 320 mg) via IV at Day 1
Placebo
DrugParticipants will receive a single dose of placebo via IV at Day 1
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: JY1001Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Adverse events (AEs)
Incidence of Adverse events (AEs)
Time frame
Day 1 to Day 4Secondary outcomes
1
Maximum concentration (Cmax)
Cmax was the highest concentration observed directly from data
Time frame
Day 1 to Day 42
Area under the concentration-time curve
Reflects the actual body exposure to drug after administration of sinlge and multiple dose
Time frame
Day 1 to Day 43
Time to Cmax (Tmax)
Tmax was the time to reach maximum observed plasma concentration
Time frame
Day 1 to Day 44
Elimination half-life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time frame
Day 1 to Day 4 Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: