Trial · NCT07892469
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Intravenous Doses of NH302 Injection in Healthy Participants
NCT07892469, Phase 1, Not yet recruiting, The Third Xiangya Hospital of Central South University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Intravenous Doses of NH302 Injection in Healthy Participants. Trials, record NCT07892469. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07892469
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Intravenous Doses of NH302 Injection in Healthy Participants
- NCT number
- NCT07892469
- Status
- Not yet recruiting
- Phases
- Phase 1
- Enrollment
- 62 participants, estimated
- Lead sponsor
- The Third Xiangya Hospital of Central South University
- Conditions
- Healthy Volunteers
- Interventions
- NH302 injection, Placebo
- First posted
- 2026-10-23
- Last updated
- 2026-10-23
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of adverse events (AEs) | From informed consent form signature through end of study (Day 7 ± 1 day after dosing, or longer if follow-up is required). | Number and percentage of participants with AEs |
| Primary | Incidence of serious adverse events (SAEs) | From informed consent form signature through end of study (Day 7 ± 1 day after dosing, or longer if follow-up is required). | Number and percentage of participants with SAEs |
| Primary | Blood pressure | Screening (Day -14 to Day -2), Baseline (Day -1); Day 1 predose and at 5 minutes, 10 minutes, 30 minutes, 1 hour, 4 hours, and 6 hours postdose; Day 2 (24 hours postdose); Day 3 (48 hours postdose); Day 4 (discharge) | Systolic and diastolic blood pressure will be measured in mmHg after at least 5 minutes of rest in the supine position. Blood pressure will be measured at the scheduled time points listed in the Time Frame; values at each scheduled time point will be reported separately. Assessments performed at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame. |
| Primary | Pulse rate | Screening (Day -14 to Day -2), Baseline (Day -1); Day 1 predose and at 5 minutes, 10 minutes, 30 minutes, 1 hour, 4 hours, and 6 hours postdose; Day 2 (24 hours postdose); Day 3 (48 hours postdose); Day 4 (discharge) | Pulse rate will be measured in beats per minute after at least 5 minutes of rest in the supine position. Pulse rate will be measured at the scheduled time points listed in the Time Frame; values at each scheduled time point will be reported separately. Assessments performed at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame. |
| Primary | Respiratory rate | Screening (Day -14 to Day -2), Baseline (Day -1); Day 1 predose and at 5 minutes, 10 minutes, 30 minutes, 1 hour, 4 hours, and 6 hours postdose; Day 2 (24 hours postdose); Day 3 (48 hours postdose); Day 4 (discharge) | Respiratory rate will be measured in breaths per minute after at least 5 minutes of rest in the supine position. Values at each scheduled time point listed in the Time Frame will be reported separately. Assessments performed at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame. |
| Primary | Body temperature | Screening (Day -14 to Day -2), Baseline (Day -1), Day 1 (predose and at 5 minutes, 10 minutes, 30 minutes, 1 hour, 4 hours, and 6 hours postdose), Day 2 (24 hours postdose), Day 3 (48 hours postdose), and Day 4 (discharge) | Body temperature will be measured in degrees Celsius (°C) at the scheduled time points listed in the Time Frame; values at each scheduled time point will be reported separately. Assessments performed at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame. |
| Primary | Number of Participants With Clinically Significant Physical Examination Abnormalities | Screening (Day -14 to Day -2), Baseline (Day -1) and Day 4 (discharge) | Physical examinations will be performed by organ system, including general appearance, lymph nodes, head and neck, chest, abdomen, and mental status. Any finding will be assessed by the investigator as clinically significant (CS) or not clinically significant (NCS). This outcome measure reports the number and percentage of participants with at least one CS physical examination abnormality at each scheduled time point; multiple organ-system abnormalities in the same participant will be aggregated and counted once for this outcome measure. If the screening examination is performed within 7 days before Baseline, the Baseline examination may not be repeated, per protocol. Assessments performed at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame. |
| Primary | Number of Participants With Clinically Significant Clinical Laboratory Abnormalities | Screening (Day -14 to Day -2), Baseline (Day -1) and Day 4 (discharge) | Clinical laboratory tests include hematology, blood chemistry, urinalysis, coagulation, and thyroid function tests, as specified in the protocol. Each laboratory abnormality will be assessed by the investigator as clinically significant (CS) or not clinically significant (NCS). This outcome measure reports the number and percentage of participants with at least one CS laboratory abnormality at each scheduled time point; multiple CS abnormalities in the same participant will be aggregated and counted once for this outcome measure. If screening laboratory tests are performed within 7 days before Baseline, the Baseline tests may not be repeated, per protocol. Assessments performed at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame. |
| Primary | Number of Participants With Clinically Significant 12-Lead ECG Abnormalities | Screening (Day -14 to Day -2), Baseline (Day -1), Day 1 (predose and at 30 minutes, 1 hour, 4 hours, and 6 hours postdose), Day 2 (24 hours postdose), Day 3 (48 hours postdose), and Day 4 (discharge) | Twelve-lead ECGs will be recorded after at least 5 minutes of rest in the supine position. ECG parameters include heart rate, PR interval, QRS duration, QT interval, QTcF, and RR interval. Each ECG finding will be assessed by the investigator as clinically significant (CS) or not clinically significant (NCS). This outcome measure reports the number and percentage of participants with at least one CS 12-lead ECG abnormality at each scheduled time point; multiple ECG abnormalities in the same participant will be aggregated and counted once for this outcome measure. If the screening ECG is performed within 7 days before Baseline, the Baseline ECG may not be repeated, per protocol. Assessments performed at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame. |
| Primary | Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score | Day 1 predose, immediately after injection, and at 5 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 10 hours, 24 hours after injection, and early withdrawal (within 24 hours after dosing). | MOAA/S score ranges from 0 to 5; lower scores indicate deeper sedation. |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07892469
GET https://conductscience.org/api/trials/v1/NCT07892469/registered?page=2