Pain After SurgeryPhase 1NCT07848945
Phase I Study of JY1001 Injection
A Phase 1 study testing JY1001 in people with Pain After Surgery, run by Jemincare at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain After Surgery
- What is being tested?
- JY1001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- Nov 2026to May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female adult participants
- Men ≥50kg, women ≥45kg, and body mass index (BMI) 19-28 kg/m² (inclusive)
Who cannot join
- With any disease that the investigator judges will take risk to participants or affect the evaluation of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Dose Escalation Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics Character of a Single Dose of JY1001 Injection in Healthy Adult Participants
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.
Read the detailed description
This is a randomized, double-blind, placebo-controlled Phase I clinical trial to evaluate the safety, tolerability, and PK characteristics of a single dose of JY1001 in healthy participants.
Healthy participants will be randomized to receive JY1001 or placebo (8 participants each cohort, with a ratio of 3:1). The study includes 6 cohorts. JY1001 doses levels in each cohort will be 10 mg, 20 mg, 40 mg, 80 mg, 160 mg, and 320 mg, respectively. Eligible participants will stay at the study center one day before administration (D-1) and receive the drug at D1. They will be discharged on D4 (72 hours after administration).
Decisions on dose escalation to next cohort will be made by Safety Review Committee (SRC) consisting of investigators and sponsor representatives, based on all participants' safety and tolerability data up to 72 hours after administration and any available PK data of the previous cohort.
- Conditions
- Pain After Surgery
- Being tested
- JY1001, Placebo
- Keywords
- dose esclation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
PlaceboDrug
Participants will receive a single dose of placebo via IV at Day 1
| Study group | Role | What they receive |
|---|---|---|
| JY1001 | Experimental | Not described Receives: Drug: JY1001 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Incidence of Adverse events (AEs)
Measured: Day 1 to Day 4
Secondary outcomes (4)
Maximum concentration (Cmax)
Cmax was the highest concentration observed directly from data
Measured: Day 1 to Day 4
Area under the concentration-time curve
Reflects the actual body exposure to drug after administration of sinlge and multiple dose
Measured: Day 1 to Day 4
Time to Cmax (Tmax)
Tmax was the time to reach maximum observed plasma concentration
Measured: Day 1 to Day 4
Elimination half-life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: Day 1 to Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain After SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jemincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848945
- Sponsor's protocol ID
- JY1001-101
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Dose Escalation Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics Character of a Single Dose of JY1001 Injection in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07848945
- Acronym / sponsor ID
- JY1001-101
- Conditions
- Pain After Surgery
- Keywords
- dose esclation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- JemincareIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized, double-blind, placebo-controlled Phase I clinical trial to evaluate the safety, tolerability, and PK characteristics of a single dose of JY1001 in healthy participants.
Healthy participants will be randomized to receive JY1001 or placebo (8 participants each cohort, with a ratio of 3:1). The study includes 6 cohorts. JY1001 doses levels in each cohort will be 10 mg, 20 mg, 40 mg, 80 mg, 160 mg, and 320 mg, respectively. Eligible participants will stay at the study center one day before administration (D-1) and receive the drug at D1. They will be discharged on D4 (72 hours after administration).
Decisions on dose escalation to next cohort will be made by Safety Review Committee (SRC) consisting of investigators and sponsor representatives, based on all participants' safety and tolerability data up to 72 hours after administration and any available PK data of the previous cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JY1001 | Experimental | Drug: JY1001 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male or female adult participants
- Men ≥50kg, women ≥45kg, and body mass index (BMI) 19-28 kg/m² (inclusive)
Key exclusion criteria (1 listed)
- With any disease that the investigator judges will take risk to participants or affect the evaluation of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JY1001Participants will receive a single dose of JY1001 (10 mg, 20 mg, 40 mg, 80 mg, 160 mg, 320 mg) via IV at Day 1 | Drug | JY1001 |
| PlaceboParticipants will receive a single dose of placebo via IV at Day 1 | Drug | Placebo |
Primary outcome
Adverse events (AEs)
Time frame: Day 1 to Day 4
Incidence of Adverse events (AEs)
4 secondary outcomes
Maximum concentration (Cmax)
Time frame: Day 1 to Day 4
Area under the concentration-time curve
Time frame: Day 1 to Day 4
Time to Cmax (Tmax)
Time frame: Day 1 to Day 4
Elimination half-life (t1/2)
Time frame: Day 1 to Day 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JY1001 in people with Pain After Surgery, run by Jemincare at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mengchang Yang (028-87394243, ymc681@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) (time frame: Day 1 to Day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.