NCT07200596 The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of SHR-3045 in Healthy Subjects
| NCT ID | NCT07200596 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Guangdong Hengrui Pharmaceutical Co., Ltd |
| Condition | Rheumatoid Arthritis (RA) |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2025-10-08 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 16 participants in total. It began in 2025-10-08 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Subjects with ability to understand the trial procedures and possible adverse events, voluntary participation in the trial. 2. Subjects who can provide written informed consent. 3. Males or females aged 18-55 years (both inclusive). 4. Males with body weight ≥ 50 kg, or females with body weight ≥ 45 kg, body mass index (BMI) 19-28 kg/m2 (both inclusive). 5. No clinically significant abnormalities in the medical history, general physical examinations, vital signs and laboratory tests. Exclusion Criteria: 1. Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening. 2. Known or suspected history of drug abuse. 3. Addiction to tobacco and alcohol. 4. Individuals who are unable to adhere to the dietary requirements of this trial during the study period. 5. Judged by the investigator, there are any other conditions that interfere with the results evaluation of the trial.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07200596 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Rheumatoid Arthritis (RA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07200596 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07200596 currently recruiting?
Yes, NCT07200596 is actively recruiting participants. Contact the research team at junlin.huang.jh91@hengrui.com for enrollment information.
Where is the NCT07200596 trial being conducted?
This trial is being conducted at Hefei, China.
Who is sponsoring the NCT07200596 clinical trial?
NCT07200596 is sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd. The trial plans to enroll 16 participants.
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