The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of SHR-3045 in Healthy Subjects
1 other identifier
interventional
16
1 country
1
Brief Summary
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single-dose subcutaneous injection of SHR-3045 in healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2025
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2025
CompletedFirst Posted
Study publicly available on registry
October 1, 2025
CompletedStudy Start
First participant enrolled
October 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedNovember 17, 2025
October 1, 2025
5 months
September 23, 2025
November 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse events (AEs)
From screening period up to Day 113.
Secondary Outcomes (7)
Area under the concentration-time curve from time 0 to the last time point after SHR-3045 administration (AUC0-last).
Post-dose at Day 1 to Day 113.
Area under the concentration-time curve from time 0 to infinity after SHR-3045 administration (AUC0-inf).
Post-dose at Day 1 to Day 113.
Maximum observed concentration of SHR-3045 (Cmax).
Post-dose at Day 1 to Day 113.
Time to maximum observed concentration of SHR-3045 (Tmax).
Post-dose at Day 1 to Day 113.
Apparent clearance of SHR-3045 (CL/F).
Post-dose at Day 1 to Day 113.
- +2 more secondary outcomes
Study Arms (2)
SHR-3045 Group
EXPERIMENTALSHR-3045 Placebo Group
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Subjects with ability to understand the trial procedures and possible adverse events, voluntary participation in the trial.
- Subjects who can provide written informed consent.
- Males or females aged 18-55 years (both inclusive).
- Males with body weight ≥ 50 kg, or females with body weight ≥ 45 kg, body mass index (BMI) 19-28 kg/m2 (both inclusive).
- No clinically significant abnormalities in the medical history, general physical examinations, vital signs and laboratory tests.
You may not qualify if:
- Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening.
- Known or suspected history of drug abuse.
- Addiction to tobacco and alcohol.
- Individuals who are unable to adhere to the dietary requirements of this trial during the study period.
- Judged by the investigator, there are any other conditions that interfere with the results evaluation of the trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Frist Affiliated Hospital of USTC (Anhui Provincial Hospital)
Hefei, Anhui, 230001, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2025
First Posted
October 1, 2025
Study Start
October 8, 2025
Primary Completion
March 1, 2026
Study Completion
March 1, 2026
Last Updated
November 17, 2025
Record last verified: 2025-10