NCT07195604 A Single Ascending Dose of HRS-2162 in Healthy Subjects
| NCT ID | NCT07195604 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Fujian Shengdi Pharmaceutical Co., Ltd. |
| Condition | Reversal of Neuromuscular Blockade |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2025-09-25 |
| Primary Completion | 2025-12 |
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 64 participants in total. It began in 2025-09-25 with a primary completion date of 2025-12.
⚠ 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 and tolerability of HRS-2162 injection in a single dose in healthy subjects, as well as the characteristics of PK/PD
Eligibility Criteria
Inclusion Criteria: 1. The subjects voluntarily signed the informed consent form. 2. Applicants must be between 18 and 45 years old at the time of signing the informed consent form, and both men and women are eligible . 3. ASA classification is Grade I (only Parts Two and three) 4. Male weight ≥50 kg, female weight ≥45 kg, body mass index between 19 and 28 kg/m ². 5. Adopt efficient contraceptive measures Exclusion Criteria: 1. Those with a past or current clinical acute or chronic disease 2. Those with a history of hereditary bleeding or coagulation disorders or non-traumatic bleeding . 3. Those with a history of neuromuscular diseases or poliomyelitis 4. Those with a history of anesthesia complications. 5. Those whose laboratory test results during the screening period or baseline period exceed the normal range and have clinical significance 6. The blood pressure of the subjects was abnormal and was judged by the researchers to be of clinical significance 7. The subject has a history of severe systemic allergies for any reason. 8. The subjects took steroid hormone drugs within 7 half-lives or 14 days before administrationSmoke ≥5 cigarettes per day within 3 months prior to the study. 9. History of drug abuse. 10. Those who the researchers considered unsuitable for inclusion
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07195604 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Reversal of Neuromuscular Blockade. 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 NCT07195604 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 NCT07195604 currently recruiting?
Yes, NCT07195604 is actively recruiting participants. Contact the research team at yuanyuan.huang@hengrui.com for enrollment information.
Where is the NCT07195604 trial being conducted?
This trial is being conducted at Chengdu, China.
Who is sponsoring the NCT07195604 clinical trial?
NCT07195604 is sponsored by Fujian Shengdi Pharmaceutical Co., Ltd.. The trial plans to enroll 64 participants.