NCT07848945

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
6mo left

Started Nov 2026

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 30, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

September 30, 2026

Status Verified

September 1, 2026

Enrollment Period

6 months

First QC Date

September 17, 2026

Last Update Submit

September 23, 2026

Conditions

Pain After Surgery

Keywords

dose esclation

Outcome Measures

Primary Outcomes (1)

  • Adverse events (AEs)

    Incidence of Adverse events (AEs)

    Day 1 to Day 4

Secondary Outcomes (4)

  • Maximum concentration (Cmax)

    Day 1 to Day 4

  • Area under the concentration-time curve

    Day 1 to Day 4

  • Time to Cmax (Tmax)

    Day 1 to Day 4

  • Elimination half-life (t1/2)

    Day 1 to Day 4

Study Arms (2)

JY1001

EXPERIMENTAL
Drug: JY1001

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

JY1001DRUG

Participants will receive a single dose of JY1001 (10 mg, 20 mg, 40 mg, 80 mg, 160 mg, 320 mg) via IV at Day 1

JY1001
PlaceboDRUG

Participants will receive a single dose of placebo via IV at Day 1

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male or female adult participants
  • Men ≥50kg, women ≥45kg, and body mass index (BMI) 19-28 kg/m² (inclusive)

You may not qualify if:

  • With any disease that the investigator judges will take risk to participants or affect the evaluation of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Location

Central Study Contacts

Mengchang Yang

CONTACT

028-87394243ymc681@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2026

First Posted

September 30, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

September 30, 2026

Record last verified: 2026-09

Locations

CN(1)