A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Intravenous Doses of NH302 Injection in Healthy Participants

NCT07892469 | Not Yet Recruiting Phase 1

• 1 other identifier: NH302-11
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief 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. Participants will receive one dose of NH302 or placebo. The study includes screening, baseline, treatment, and follow-up.

Conditions

Healthy Volunteers

Keywords

NH302; kappa opioid receptor agonist; acute pain; safety; tolerability; pharmacokinetics; single ascending dose; healthy volunteers

Outcome Measures

Primary Outcomes (12)

• Incidence of adverse events (AEs)

  Number and percentage of participants with AEs

  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

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Screening (Day -14 to Day -2), Baseline (Day -1), and Day 4 (discharge)

Secondary Outcomes (18)

• Plasma Cmax of NH302 and metabolites, if applicable

  Day 1 (predose) through 48 hours postdose

• Plasma Tmax of NH302 and metabolites, if applicable

  Day 1 (predose) through 48 hours postdose

• Plasma AUC0-t of NH302 and metabolites, if applicable

  Day 1 (predose) through 48 hours postdose

• Plasma AUC0-inf of NH302 and metabolites, if applicable

  Day 1 (predose) through 48 hours postdose

• Plasma AUC_%Extrap of NH302 and metabolites, if applicable

  Day 1 (predose) through 48 hours postdose

Other Outcomes (3)

• Prolactin level

  Day 1 predose, immediately after injection, and at 30 minutes, 1 hour, 3 hours, 6 hours, 24 hours after injection; early withdrawal (within 24 hours after dosing).

• Antidiuretic hormone (ADH) level

  Day 1 predose, immediately after injection, and at 30 minutes, 1 hour, 3 hours, 6 hours, 24 hours after injection; early withdrawal (within 24 hours after dosing).

• Pain tolerance time (PTT)

  Day 1 predose, and at 30 minutes, 1 hour, 3 hours, 6 hours, 10 hours, 24 hours after injection; early withdrawal (within 24 hours after dosing). Post-dose time windows are ±30 minutes.

Study Arms (12)

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Drug: Placebo

Interventions

NH302 injection DRUG

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.

NH302 0.15 μg/kg; NH302 0.45 μg/kg; NH302 1 μg/kg; NH302 2 μg/kg; NH302 3.5 μg/kg; NH302 5 μg/kg

Placebo DRUG

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.

Placebo for 0.15 μg/kg group; Placebo for 0.45 μg/kg group; Placebo for 1 μg/kg group; Placebo for 2 μg/kg group; Placebo for 3.5 μg/kg group; Placebo for 5 μg/kg group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead
• Jiangsu Nhwa Pharmaceutical Co., Ltd.: collaborator

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Pharmacology

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: October 23, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: October 23, 2026

Record last verified: 2026-10