Reversal of Neuromuscular BlockadePhase 1NCT07195604
A Single Ascending Dose of HRS-2162 in Healthy Subjects
A Phase 1 study testing HRS-2162 in people with Reversal of Neuromuscular Blockade, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Reversal of Neuromuscular Blockade
- What is being tested?
- HRS-2162
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2025to 9 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- The subjects voluntarily signed the informed consent form.
- 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 .
- ASA classification is Grade I (only Parts Two and three)
- Male weight ≥50 kg, female weight ≥45 kg, body mass index between 19 and 28 kg/m ².
- Adopt efficient contraceptive measures
Who cannot join
- Those with a past or current clinical acute or chronic disease
- Those with a history of hereditary bleeding or coagulation disorders or non-traumatic bleeding .
- Those with a history of neuromuscular diseases or poliomyelitis
- Those with a history of anesthesia complications.
- Those whose laboratory test results during the screening period or baseline period exceed the normal range and have clinical significance
- The blood pressure of the subjects was abnormal and was judged by the researchers to be of clinical significance
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- The subject has a history of severe systemic allergies for any reason.
- 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.
- History of drug abuse.
- Those who the researchers considered unsuitable for inclusion
Trial locations and contacts
1 site in 1 country.
China1 site
Sichuan Academy of Medical Sciences &Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
About this study
Official title: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of HRS-2162 Injection in Healthy Subjects
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
- Conditions
- Reversal of Neuromuscular Blockade
- Being tested
- HRS-2162, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-2162Drug
HRS-2162
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Dose Level：A1(Part1) | Experimental | Subject will receive HRS-2162 at dose level A1. Subject will receive placebo at dose level A1. Receives: Drug: HRS-2162; Drug: Placebo |
| Dose Level：A2(Part1) . | Experimental | Subject will receive HRS-2162 at dose level A2. Subject will receive placebo at dose level A2. Receives: Drug: HRS-2162; Drug: Placebo |
| Dose Level：B(Part1+Part2) | Experimental | Subject will receive HRS-2162 at dose level B. Subject will receive placebo at dose level B. Receives: Drug: HRS-2162; Drug: Placebo |
| Dose Level：C(Part1) | Experimental | Subject will receive HRS-2162 at dose level C. Subject will receive placebo at dose level C. Receives: Drug: HRS-2162; Drug: Placebo |
| Dose Level：D(Part1+Part3) | Experimental | Subject will receive HRS-2162 at dose level D. Subject will receive placebo at dose level D. Receives: Drug: HRS-2162; Drug: Placebo |
| Dose Level：E(Part1) | Experimental | Subject will receive HRS-2162 at dose level E. Subject will receive placebo at dose level E. Receives: Drug: HRS-2162; Drug: Placebo |
| Dose Level：F(Part3) | Experimental | Subject will receive HRS-2162 at dose level F Receives: Drug: HRS-2162 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of adverse events
Measured: From ICF signing date to Day7
Secondary outcomes (7)
Maximum observed concentration of HRS-2162 (Cmax)
Measured: 0 hour to 24 hour after administration
Area under the serum concentration time curve (AUC) of HRS-2162
Measured: 0 hour to 24 hour after administration
Time to maximum observed concentration (Tmax) of HRS-2162
Measured: 0 hour to 24 hour after administration
Half-life (T1/2) of HRS-2162
Measured: 0 hour to 24 hour after administration
Clearance (CL) of HRS-2162
Measured: 0 hour to 24 hour after administration
Volume of distribution (Vz) of HRS-2162
Measured: 0 hour to 24 hour after administration
Efficacy endpoint: The time required from the administration of the investigational drug to the recovery of the TOFr value (T4/T1 value)
Measured: 0 hour to 1 hour after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start25 Sep 2025
- Primary completion9 Oct 2025
- Study completion9 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reversal of Neuromuscular BlockadeStudies of the same condition, open and under way.
- More trials run by Fujian Shengdi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195604
- Sponsor's protocol ID
- HRS-2162-101
- Status last verified
- Sep 2025
- First submitted
- 14 Sep 2025
- Last updated
- 22 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 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of HRS-2162 Injection in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07195604
- Acronym / sponsor ID
- HRS-2162-101
- Conditions
- Reversal of Neuromuscular Blockade
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- 9 Oct 2025 (actual)
- Study completion
- 9 Oct 2025 (actual)
- First posted
- 26 Sep 2025 (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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Dose Level：A1(Part1) | Experimental | Drug: HRS-2162, Drug: PlaceboSubject will receive HRS-2162 at dose level A1. Subject will receive placebo at dose level A1. |
| Dose Level：A2(Part1) . | Experimental | Drug: HRS-2162, Drug: PlaceboSubject will receive HRS-2162 at dose level A2. Subject will receive placebo at dose level A2. |
| Dose Level：B(Part1+Part2) | Experimental | Drug: HRS-2162, Drug: PlaceboSubject will receive HRS-2162 at dose level B. Subject will receive placebo at dose level B. |
| Dose Level：C(Part1) | Experimental | Drug: HRS-2162, Drug: PlaceboSubject will receive HRS-2162 at dose level C. Subject will receive placebo at dose level C. |
| Dose Level：D(Part1+Part3) | Experimental | Drug: HRS-2162, Drug: PlaceboSubject will receive HRS-2162 at dose level D. Subject will receive placebo at dose level D. |
| Dose Level：E(Part1) | Experimental | Drug: HRS-2162, Drug: PlaceboSubject will receive HRS-2162 at dose level E. Subject will receive placebo at dose level E. |
| Dose Level：F(Part3) | Experimental | Drug: HRS-2162Subject will receive HRS-2162 at dose level F |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The subjects voluntarily signed the informed consent form.
- 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 .
- ASA classification is Grade I (only Parts Two and three)
- Male weight ≥50 kg, female weight ≥45 kg, body mass index between 19 and 28 kg/m ².
- Adopt efficient contraceptive measures
Key exclusion criteria (10 listed)
- Those with a past or current clinical acute or chronic disease
- Those with a history of hereditary bleeding or coagulation disorders or non-traumatic bleeding .
- Those with a history of neuromuscular diseases or poliomyelitis
- Those with a history of anesthesia complications.
- Those whose laboratory test results during the screening period or baseline period exceed the normal range and have clinical significance
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 |
|---|---|---|
| HRS-2162HRS-2162 | Drug | Dose Level：A1(Part1), Dose Level：A2(Part1) ., Dose Level：B(Part1+Part2), Dose Level：C(Part1), Dose Level：D(Part1+Part3), Dose Level：E(Part1), Dose Level：F(Part3) |
| PlaceboPlacebo | Drug | Dose Level：A1(Part1), Dose Level：A2(Part1) ., Dose Level：B(Part1+Part2), Dose Level：C(Part1), Dose Level：D(Part1+Part3), Dose Level：E(Part1) |
Primary outcome
The incidence and severity of adverse events
Time frame: From ICF signing date to Day7
7 secondary outcomes
Maximum observed concentration of HRS-2162 (Cmax)
Time frame: 0 hour to 24 hour after administration
Area under the serum concentration time curve (AUC) of HRS-2162
Time frame: 0 hour to 24 hour after administration
Time to maximum observed concentration (Tmax) of HRS-2162
Time frame: 0 hour to 24 hour after administration
Half-life (T1/2) of HRS-2162
Time frame: 0 hour to 24 hour after administration
Clearance (CL) of HRS-2162
Time frame: 0 hour to 24 hour after administration
Volume of distribution (Vz) of HRS-2162
Time frame: 0 hour to 24 hour after administration
Efficacy endpoint: The time required from the administration of the investigational drug to the recovery of the TOFr value (T4/T1 value)
Time frame: 0 hour to 1 hour after administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 HRS-2162 in people with Reversal of Neuromuscular Blockade, run by Fujian Shengdi Pharmaceutical Co., Ltd. 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 22 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of adverse events (time frame: From ICF signing date to Day7). 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 22 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.