Healthy VolunteersPhase 1NCT07892469
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Intravenous Doses of NH302 Injection in Healthy Participants
A Phase 1 study testing NH302 injection in people with Healthy Volunteers, run by The Third Xiangya Hospital of Central South University.
Trial summary
This is a first-in-human study of NH302 injection in healthy participants. The study will test single intravenous doses of NH302 to evaluate its safety and tolerability, how the body processes NH302, and its effects on selected pharmacodynamic markers. Approximately 62 healthy adults will participate. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- NH302 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 30 Sep 2027
- Phase
- Phase 1
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
- Healthy male and female participants aged 18 to 45 years, inclusive, at screening.
- Body mass index (BMI) of 19 to 26 kg/m², inclusive, and body weight ≥45 kg.
- Participant fully understands the purpose, content, procedures, and potential risks of the study, voluntarily agrees to participate, and signs the informed consent form.
- Able to communicate well with the investigator and willing and able to comply with the lifestyle restrictions and study procedures specified in the protocol.
Who cannot join
- History or presence of any disease or dysfunction that, in the investigator's judgment, may affect the clinical trial, including but not limited to chronic or severe diseases of the central nervous system, cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, blood and lymphatic system, or psychiatric disorders.
- Abnormal QT/QTc at baseline, including QTcF ≥450 ms; other risk factors for torsades de pointes (e.g., heart failure, hypokalemia, hypomagnesemia, family history of long QT syndrome); or potential bundle branch block.
- Clinically significant abnormalities on physical examination, vital signs, hematology, blood chemistry, urinalysis, coagulation, thyroid function tests, chest X-ray, abdominal ultrasound, or 12-lead ECG.
- History of severe drug allergy (known or suspected allergy to NH302 injection or its excipients), severe specific allergic disease/history (e.g., asthma, urticaria, eczematous dermatitis), or severe allergic constitution (two or more food or drug allergies).
- Medical conditions that may induce or worsen somnolence or dizziness, including active dizziness, motion sickness, history of orthostatic hypotension, history of syncope, history of vertigo (including Meniere's disease), moderate-to-severe sleep apnea syndrome, narcolepsy, or other conditions manifested by somnolence or dizziness.
- Need to drive, work at heights, operate precision machinery, or perform other activities requiring high alertness within 24 hours after discharge from the study and unable to suspend these activities.
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- History of drug abuse, drug dependence, or substance abuse within 1 year before screening, or positive urine drug screen.
- Use of any hepatic enzyme inhibitor or inducer within 1 month before screening (e.g., inducers: phenobarbital, rifampicin, carbamazepine, phenytoin, dexamethasone; inhibitors: fluvoxamine, S-mephenytoin, propofol, isoniazid, phenothiazines).
- Received an inactivated vaccine within 1 month before screening; received an inactivated or live attenuated vaccine within 3 months before screening; or plans to receive an inactivated or live attenuated vaccine during the study.
- Blood loss or donation of more than 400 mL within 3 months before screening (excluding menstrual bleeding in women); transfusion or receipt of blood products exceeding 400 mL within 3 months before the trial; or plans to donate blood during the study or within 1 month after study completion.
- History of surgery within 3 months before screening, incomplete recovery from surgery, or planned surgery during the study.
- Use of any prescription drug, over-the-counter drug, herbal medicine, or dietary supplement (including vitamins and health products) within 2 weeks before dosing or within 5 half-lives of the drug, whichever is longer.
- History of alcohol abuse within 6 months before screening (i.e., more than 14 standard units per week; 1 unit = 360 mL beer, 45 mL of 40% spirits, or 150 mL wine), positive alcohol breath test (result >0), or inability to abstain from alcohol during the study.
- Positive smoking test; smoking ≥5 cigarettes per day within 6 months before screening; or inability to stop using any tobacco product (including nicotine gum or transdermal nicotine patches) during the study.
- Intake of caffeine-containing food or beverages (e.g., coffee, strong tea, chocolate, caffeine-containing carbonated drinks, cola) within 48 hours before screening.
- Intake of any glucose-rich beverage or food within 48 hours before screening.
- Special dietary requirements, inability to comply with a standardized diet, or dysphagia; or anorexia, dieting, or significant abnormal diet (e.g., dieting, low sodium) started within 4 weeks before screening.
- Positive or non-negative results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), or Treponema pallidum (TP) antibody.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 × upper limit of normal (ULN); or creatinine (Cr), blood urea nitrogen (BUN), or urea >ULN.
- Difficulty with blood sampling, intolerance to venipuncture, or history of hemophobia or needle phobia.
- Pregnant or breastfeeding women at screening; or participants who refuse to use effective contraception (e.g., abstinence, intrauterine device) during the study and within 3 months after study completion, or who plan to donate sperm or oocytes.
- Participation in any clinical trial within 3 months before dosing or still in the follow-up period of another trial.
- Poor expected compliance or any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase 1 Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Administration of NH302 Injection in Healthy Participants
This is a first-in-human study of NH302 injection in healthy participants. The study will test single intravenous doses of NH302 to evaluate its safety and tolerability, how the body processes NH302, and its effects on selected pharmacodynamic markers. Approximately 62 healthy adults will participate. Participants will receive one dose of NH302 or placebo. The study includes screening, baseline, treatment, and follow-up.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) Phase 1 study of NH302 injection in healthy participants. Six dose levels are planned: 0.15, 0.45, 1, 2, 3.5, and 5 μg/kg. Each dose group plans to enroll 10 participants, randomized 8:2 to NH302 or placebo. A pilot cohort of 2 participants will receive NH302 0.15 μg/kg before formal dose escalation. NH302 is administered as a single intravenous infusion over 15 minutes ± 10 seconds on Day 1. The study evaluates safety, tolerability, pharmacokinetics, metabolism and excretion, QT/QTc effects, and exploratory pharmacodynamic markers including prolactin, antidiuretic hormone, and pain tolerance time.
- Conditions
- Healthy Volunteers
- Being tested
- NH302 injection, Placebo
- Keywords
- NH302, kappa opioid receptor agonist, acute pain, safety, tolerability, pharmacokinetics, single ascending dose, healthy volunteers
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NH302 injectionDrug
NH302 is a selective peripheral kappa opioid receptor agonist. It is supplied as a sterile injection (1 mL: 0.1 mg). For each dose group, NH302 is diluted with 0.9% sodium chloride injection to a total volume of 20 mL and administered as a single intravenous infusion over 15 minutes ± 10 seconds on Day 1. Dose levels: 0.15, 0.45, 1, 2, 3.5, and 5 μg/kg. The dose is calculated based on body weight on Day 1.
PlaceboDrug
Matching placebo supplied by the sponsor (1 mL: 0 mg). It has the same appearance as NH302 injection and is prepared and administered in the same manner to maintain blinding: total volume 20 mL, single intravenous infusion over 15 minutes ± 10 seconds on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| NH302 0.15 μg/kg | Experimental | Single intravenous dose of NH302 0.15 μg/kg, diluted in 0.9% sodium chloride, total volume 20 mL, infused over 15 minutes ± 10 seconds on Day 1. Receives: Drug: NH302 injection |
| Placebo for 0.15 μg/kg group | Placebo comparator | Single intravenous dose of matching placebo, total volume 20 mL, infused over 15 minutes ± 10 seconds on Day 1. Receives: Drug: Placebo |
| NH302 0.45 μg/kg | Experimental | Single intravenous dose of NH302 0.45 μg/kg, diluted in 0.9% sodium chloride, total volume 20 mL, infused over 15 minutes ± 10 seconds on Day 1. Receives: Drug: NH302 injection |
| Placebo for 0.45 μg/kg group | Placebo comparator | Single intravenous dose of matching placebo, total volume 20 mL, infused over 15 minutes ± 10 seconds on Day 1. Receives: Drug: Placebo |
| NH302 1 μg/kg | Experimental | Single intravenous dose of NH302 1 μg/kg, diluted in 0.9% sodium chloride, total volume 20 mL, infused over 15 minutes ± 10 seconds on Day 1. Receives: Drug: NH302 injection |
| Placebo for 1 μg/kg group | Placebo comparator | Single intravenous dose of matching placebo, total volume 20 mL, infused over 15 minutes ± 10 seconds on Day 1. Receives: Drug: Placebo |
| NH302 2 μg/kg | Experimental | Single intravenous dose of NH302 2 μg/kg, diluted in 0.9% sodium chloride, total volume 20 mL, infused over 15 minutes ± 10 seconds on Day 1. Receives: Drug: NH302 injection |
| Placebo for 2 μg/kg group | Placebo comparator | Single intravenous dose of matching placebo, total volume 20 mL, infused over 15 minutes ± 10 seconds on Day 1. Receives: Drug: Placebo |
| NH302 3.5 μg/kg | Experimental | Single intravenous dose of NH302 3.5 μg/kg, diluted in 0.9% sodium chloride, total volume 20 mL, infused over 15 minutes ± 10 seconds on Day 1. Receives: Drug: NH302 injection |
| Placebo for 3.5 μg/kg group | Placebo comparator | Single intravenous dose of matching placebo, total volume 20 mL, infused over 15 minutes ± 10 seconds on Day 1. Receives: Drug: Placebo |
| NH302 5 μg/kg | Experimental | Single intravenous dose of NH302 5 μg/kg, diluted in 0.9% sodium chloride, total volume 20 mL, infused over 15 minutes ± 10 seconds on Day 1. Receives: Drug: NH302 injection |
| Placebo for 5 μg/kg group | Placebo comparator | Single intravenous dose of matching placebo, total volume 20 mL, infused over 15 minutes ± 10 seconds on Day 1. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
Number and percentage of participants with AEs
Measured: From informed consent form signature through end of study (Day 7 ± 1 day after dosing, or longer if follow-up is required).
Incidence of serious adverse events (SAEs)
Number and percentage of participants with SAEs
Measured: From informed consent form signature through end of study (Day 7 ± 1 day after dosing, or longer if follow-up is required).
Blood pressure
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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)
Body temperature
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.
Measured: 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)
Number of Participants With Clinically Significant Physical Examination Abnormalities
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.
Measured: Screening (Day -14 to Day -2), Baseline (Day -1) and Day 4 (discharge)
Number of Participants With Clinically Significant Clinical Laboratory Abnormalities
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.
Measured: Screening (Day -14 to Day -2), Baseline (Day -1) and Day 4 (discharge)
Number of Participants With Clinically Significant 12-Lead ECG Abnormalities
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.
Measured: 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)
Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score
MOAA/S score ranges from 0 to 5; lower scores indicate deeper sedation.
Measured: 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).
Visual analogue scale (VAS) craving score
VAS craving score ranges from 0 to 10; 0 = no craving, 10 = extreme craving.
Measured: Day 1 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).
Number of Participants With Clinically Significant Thyroid Function Test Abnormalities
Thyroid function tests include total triiodothyronine (TT3), total thyroxine (TT4), free triiodothyronine (FT3), free thyroxine (FT4), and thyroid stimulating hormone (TSH). Each test result 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 thyroid function test abnormality at each scheduled time point; multiple CS abnormalities in the same participant will be aggregated and counted once for this outcome measure. Assessments performed at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame.
Measured: Screening (Day -14 to Day -2), Baseline (Day -1), and Day 4 (discharge)
Secondary outcomes (18)
Plasma Cmax of NH302 and metabolites, if applicable
Plasma concentrations of NH302 and metabolites (if applicable) will be measured by HPLC-MS/MS. Cmax will be derived from the concentration-time data and reported in ng/mL for NH302 and for each metabolite separately. Blood samples for PK will be collected predose and from 15 seconds to 48 hours postdose. PK samples collected at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame.
Measured: Day 1 (predose) through 48 hours postdose
Plasma Tmax of NH302 and metabolites, if applicable
Plasma concentrations of NH302 and metabolites (if applicable) will be measured by HPLC-MS/MS. Tmax will be derived from the concentration-time data and reported in hours for NH302 and for each metabolite separately. Blood samples for PK will be collected predose and from 15 seconds to 48 hours postdose. PK samples collected at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame.
Measured: Day 1 (predose) through 48 hours postdose
Plasma AUC0-t of NH302 and metabolites, if applicable
Plasma concentrations of NH302 and metabolites (if applicable) will be measured by HPLC-MS/MS. AUC0-t will be calculated from time zero to the last quantifiable time point using the linear trapezoidal rule and reported in h·ng/mL for NH302 and for each metabolite separately. Blood samples for PK will be collected predose and from 15 seconds to 48 hours postdose. PK samples collected at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame.
Measured: Day 1 (predose) through 48 hours postdose
Plasma AUC0-inf of NH302 and metabolites, if applicable
Plasma concentrations of NH302 and metabolites (if applicable) will be measured by HPLC-MS/MS. AUC0-inf will be calculated as AUC0-t plus Clast/λz, where Clast is the last quantifiable plasma concentration and λz is the terminal elimination rate constant, and will be reported in h·ng/mL for NH302 and for each metabolite separately. The percentage of AUC0-inf obtained by extrapolation will also be reported. Blood samples for PK will be collected predose and from 15 seconds to 48 hours postdose. PK samples collected at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame.
Measured: Day 1 (predose) through 48 hours postdose
Plasma AUC_%Extrap of NH302 and metabolites, if applicable
Plasma concentrations of NH302 and metabolites (if applicable) will be measured by HPLC-MS/MS. The percentage of AUC0-inf obtained by extrapolation (AUC_%Extrap) will be calculated as [(AUC0-inf - AUC0-t) / AUC0-inf] × 100% and reported as a percentage for NH302 and for each metabolite separately. Blood samples for PK will be collected predose and from 15 seconds to 48 hours postdose. PK samples collected at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame.
Measured: Day 1 (predose) through 48 hours postdose
Plasma Clearance (CL) of NH302 and Metabolites, if Applicable
Plasma concentrations of NH302 and metabolites (if applicable) will be measured by HPLC-MS/MS. CL will be calculated as the administered dose divided by AUC0-inf and reported in mL/h/kg for NH302. For metabolites, CL will be reported only if the administered dose and a reliable AUC0-inf are available; otherwise, metabolite concentration and AUC will be reported without CL. Blood samples for PK will be collected predose and from 15 seconds to 48 hours postdose. PK samples collected at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame.
Measured: Day 1 (predose) through 48 hours postdose
Plasma Apparent Volume of Distribution (Vz) of NH302 and Metabolites, if Applicable
Plasma concentrations of NH302 and metabolites (if applicable) will be measured by HPLC-MS/MS. Vz will be calculated as CL/λz, where CL is clearance and λz is the terminal elimination rate constant, and reported in mL/kg for NH302. For metabolites, Vz will be reported only if the administered dose and a reliable AUC0-inf and λz are available; otherwise, metabolite concentration and AUC will be reported without Vz. Blood samples for PK will be collected predose and from 15 seconds to 48 hours postdose. PK samples collected at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame.
Measured: Day 1 (predose) through 48 hours postdose
Plasma Terminal Elimination Rate Constant (λz) of NH302 and Metabolites, if Applicable
Plasma concentrations of NH302 and metabolites (if applicable) will be measured by HPLC-MS/MS. λz will be estimated by linear regression of the log-transformed plasma concentration versus time during the terminal elimination phase, using the negative slope, and will be reported in h-¹ for NH302 and for each metabolite separately. For metabolites, λz will be reported only if a reliable terminal elimination phase can be identified; otherwise, metabolite concentration and AUC will be reported without λz. Blood samples for PK will be collected predose and from 15 seconds to 48 hours postdose. PK samples collected at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame.
Measured: Day 1 (predose) through 48 hours postdose
Plasma Terminal Elimination Half-life (t1/2) of NH302 and Metabolites, if Applicable
Plasma concentrations of NH302 and metabolites (if applicable) will be measured by HPLC-MS/MS. t1/2 will be calculated as ln(2)/λz, where λz is the terminal elimination rate constant estimated from the terminal phase of the concentration-time curve, and will be reported in hours for NH302 and for each metabolite separately. For metabolites, t1/2 will be reported only if a reliable terminal elimination phase can be identified; otherwise, metabolite concentration and AUC will be reported without t1/2. Blood samples for PK will be collected predose and from 15 seconds to 48 hours postdose. PK samples collected at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame.
Measured: Day 1 (predose) through 48 hours postdose
Plasma Mean Residence Time from Time Zero to Infinity (MRT0-inf) of NH302 and Metabolites, if Applicable
Plasma concentrations of NH302 and metabolites (if applicable) will be measured by HPLC-MS/MS. MRT0-inf will be calculated as AUMC0-inf/AUC0-inf, where AUMC0-inf is the area under the first moment curve from time zero to infinity and AUC0-inf is the area under the concentration-time curve from time zero to infinity, and will be reported in hours for NH302 and for each metabolite separately. For metabolites, MRT0-inf will be reported only if a reliable AUC0-inf and AUMC0-inf can be calculated; otherwise, metabolite concentration and AUC will be reported without MRT. Blood samples for PK will be collected predose and from 15 seconds to 48 hours postdose. PK samples collected at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame.
Measured: Day 1 (predose) through 48 hours postdose
Urinary Excretion Amount of NH302 and Metabolites in Each Collection Interval (Ae_t1-t2), if Applicable
Urine samples will be collected only in the 1 μg/kg dose cohort. Concentrations of NH302 and metabolites (if applicable) in urine will be measured by HPLC-MS/MS. Ae_t1-t2 will be calculated for each urine collection interval as the urine concentration multiplied by the urine volume collected during that interval, and will be reported in μg for NH302 and for each metabolite separately. Urine collection intervals are predose (morning dose day, tentative) and 0-2, 2-4, 4-8, 8-12, 12-24, and 24-48 hours postdose; if no urine is produced during an interval, that interval will not be collected and will be recorded. Urine samples collected at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame.
Measured: Day 1 (predose) and 0-2, 2-4, 4-8, 8-12, 12-24, and 24-48 hours postdose
Cumulative Urinary Excretion Amount of NH302 and Metabolites (Ae_0-t), if Applicable
Urine samples will be collected only in the 1 μg/kg dose cohort. Concentrations of NH302 and metabolites (if applicable) in urine will be measured by HPLC-MS/MS. Ae_0-t will be calculated as the cumulative urinary excretion amount from time zero to the last collection interval (48 hours postdose) by summing the excretion amounts across all scheduled urine collection intervals, and will be reported in μg for NH302 and for each metabolite separately. If no urine is produced during an interval, that interval will not be collected and will be recorded. Urine samples collected at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame.
Measured: Day 1 (predose) through 48 hours postdose
Cumulative Urinary Excretion Fraction (fe) of NH302 and Metabolites, if Applicable
Urine samples will be collected only in the 1 μg/kg dose cohort. Concentrations of NH302 and metabolites (if applicable) in urine will be measured by HPLC-MS/MS. Cumulative urinary excretion fraction (fe) will be calculated as the cumulative urinary excretion amount from time zero to 48 hours postdose divided by the administered dose, multiplied by 100%, and will be reported as a percentage for NH302 and for each metabolite separately. Urine collection intervals are predose (morning of dosing day, tentative) and 0-2, 2-4, 4-8, 8-12, 12-24, and 24-48 hours postdose; if no urine is produced during an interval, that interval will not be collected and will be recorded. Urine samples collected at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame.
Measured: Day 1 (predose) through 48 hours postdose
Renal Clearance (CLr) of NH302 and Metabolites, if Applicable
Urine samples will be collected only in the 1 μg/kg dose cohort. Concentrations of NH302 and metabolites (if applicable) in urine and plasma will be measured by HPLC-MS/MS. CLr will be calculated as the cumulative urinary excretion amount from time zero to 48 hours postdose divided by the corresponding plasma AUC over the same interval, and will be reported in mL/min for NH302 and for each metabolite separately. For metabolites, CLr will be reported only if reliable urinary excretion and plasma AUC data are available; otherwise, metabolite concentration and AUC will be reported without CLr. If no urine is produced during a collection interval, that interval will not be collected and will be recorded. Urine and plasma samples collected at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame.
Measured: Day 1 (predose) through 48 hours postdose
Cumulative Fecal Excretion Amount (Ae_0-t) of NH302 and Metabolites, if Applicable
Fecal samples will be collected only in the 1 μg/kg dose cohort. Concentrations of NH302 and metabolites (if applicable) in feces will be measured by HPLC-MS/MS. Ae_0-t will be calculated as the cumulative fecal excretion amount from time zero to 48 hours postdose by summing the excretion amount for each fecal sample collected during the interval, and will be reported in μg for NH302 and for each metabolite separately. If no bowel movement occurs within 48 hours postdose, fecal collection will continue until collection is complete, and the actual collection period will be recorded. Fecal samples collected at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame.
Measured: Day 1 (predose) through 48 hours postdose; extended until fecal collection is complete if no bowel movement occurs within 48 hours postdose
Cumulative Fecal Excretion Fraction (fe) of NH302 and Metabolites, if Applicable
Fecal samples will be collected only in the 1 μg/kg dose cohort. Concentrations of NH302 and metabolites (if applicable) in feces will be measured by HPLC-MS/MS. Cumulative fecal excretion fraction (fe) will be calculated as the cumulative fecal excretion amount from time zero to 48 hours postdose divided by the administered dose, multiplied by 100%, and will be reported as a percentage for NH302 and for each metabolite separately. If no bowel movement occurs within 48 hours postdose, fecal collection will continue until collection is complete, and the actual collection period will be recorded. Fecal samples collected at early withdrawal, if applicable, will be reported separately as unscheduled data and are not included in the protocol-scheduled Time Frame.
Measured: Day 1 (predose) through 48 hours postdose; extended until fecal collection is complete if no bowel movement occurs within 48 hours postdose
Change from baseline in QTcF interval
QTcF interval change from baseline based on Holter ECG.
Measured: Day 1 predose (-60, -45, -30 minutes), immediately after injection (+5 minutes), and at 10 minutes, 30 minutes, 1 hour, 4 hours, 6 hours, 10 hours, 24 hours after injection (Day 2).
Concentration-QTc (C-QTc) analysis
Exposure-response analysis using matched PK concentrations and ECG data to evaluate potential QT/QTc prolongation risk.
Measured: Day 1 predose through 24 hours after injection (Day 2); matched PK and ECG time points.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Nhwa Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Guoping Yang, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892469
- Sponsor's protocol ID
- NH302-11
- Status last verified
- Oct 2026
- First submitted
- 23 Sep 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No