NCT05523570CompletedPhase 1

A Study to Evaluate the Safety, Tolerability, PK and PD of HNC364 Injectable Suspension

Phase 1, Non-randomized, Single Ascending Doses (SAD) Study Following Single Injection in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HNC364 Injectable Suspension

Source: ClinicalTrials.gov · Last updated 27 Sept 2024

Brief summary (registry, in English)

This is a non-randomized, dose-escalation first-in-human study to evaluate the safety, tolerability, PK, and PD of HNC364 following intramuscular administration of single ascending doses.

Status (registry): Completed
Phase (registry): Phase 1
Study type: Interventional
Enrollment: 34 (actual)
First submitted: 24 Aug 2022
Start date: 22 Aug 2022
Primary completion date: 15 Apr 2024
Lead sponsor: Guangzhou Henovcom Bioscience Co. Ltd.
Diseases: Parkinson disease
NCT number: NCT05523570

What you commit to

Study type: Interventional · Phase 1
Participants enrolled: 34
From 22 Aug 2022 to the primary completion date, 15 Apr 2024
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Subjects who meet any of the following criteria must be excluded from the study:
1\. Prior to screening, subjects had clinically significant disease history as determined by the Investigator, including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, neoplastic, pulmonary, immunological, psychiatric, cardio cerebrovascular disease or any reported history of sleep disorder.2. Any history of suicide or at high risk for suicide assessment at screening.
3\. The subject has a history of severe allergy or allergy to the the study drug and any of its components or related excipients.
4\. Prior to screening, those who have a history of gastrointestinal, liver and kidney diseases or surgery that potentially affect the absorption, distribution, metabolism and excretion of the study drug (except for uncomplicated appendectomy and hernia repair).
5\. A history of alcoholism (alcoholism is defined as drinking 14 units of alcohol per week: 1 unit = 285 ml of beer, 25 ml of spirits, or 100 ml of wine) or positive alcohol breath test during the screening period.
6\. Those who had a history of drug abuse or used drugs within 2 years before screening or those who were positive for urinary drug screening during the screening period.
7\. Subjects who had a history of smoking or used other nicotine-containing products within 3 months before the study drug administration, or who were positive for urine nicotine test during screening.
8\. Positive blood screen for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
9\. Strong inhibitors and/or inducers of liver metabolizing enzymes (CYP1A2, 2A6, 2C8, 2C19, 3A4 and 3A5), strong inhibitors of liver metabolizing enzymes such as ciprofloxacin, clopidogrel, itraconazole, ketoconazole, ritonavir, acerbicin, etc., and strong inducers of liver metabolizing enzymes such as rifampicin, carbamazepine, phenytoin sodium, St. John's wort, etc. were used within 4 weeks before the study drug administration.
10\. Any prescription drug, over-the-counter drug, any vitamin product or Chinese herbal medicine used within 2 weeks before the study drug administration.
11\. Had consumed a special diet (including pitaya, mango, grapefruit, or certain foods containing high amounts of tyramine, etc.) or had vigorous exercise, or other factors affecting drug absorption, distribution, metabolism, excretion, etc., within 2 weeks before the administration.
12\. Had consumed chocolate, any food or beverage containing caffeine or xanthine-rich within 72 hours before the study drug administration.
13\. Taking any alcoholic product within 48 hours before the administration. 14. Donation of plasma within 30 days, or donation of blood or massive blood loss (≥ 400 ml) within 60 days, or donation of bone marrow or peripheral stem cells within 90 days before the study drug administration.
15\. Participated in other clinical trials within 30 days prior to study drug administration.
16\. Acute disease or concomitant medication from the signing of informed consent form to the study drug administration.
17\. Lactating women or those with positive serum pregnancy results. 18. The researchers believe that subjects with other factors that are not suitable to participate in this study.
Prohibitions and Restrictions：
Subjects must be willing to adhere to the following prohibitions and restrictions during the study (until final discharge from the clinic):
Use of tobacco- or nicotine-containing products, in any form, is prohibited within 3 months prior to study drug administration on Day 1 until after the EOS visit.
Within 4 weeks prior to study drug administration until 30 days post dose, any drugs known to strongly inhibit and/or induce metabolizing enzymes (CYP1A2, 2A6, 2c8, 2c19, 3A4 and 3A5) are contraindicated for use with HNC364, strong inhibitors of liver metabolizing enzymes
Within 4 weeks prior to study drug administration until 30 days post dose, dextromethorphan is contraindicated for use with HNC364.
Within 2 weeks prior to study drug administration until 44 days post dose, Meperidine, tramadol, methadone, propoxyphene, and MAO inhibitors (MAOIs), including other selective MAO-B inhibitors are contraindicated for use with HNC364.

Age in the registry: 18 years to 45 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Frontage Clinical Services, Inc. Coordinator of this site? Confirm its status	Secaucus	United States	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.