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Acute Ischemic StrokePhase 1NCT06388772

Study to Assess PK, Safety and Tolerability Early in Healthy Subjects

A Phase 1 study testing QHRD106 Injection in people with Acute Ischemic Stroke, run by Changzhou Qianhong Bio-pharma Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of QHRD106 early in Chinese healthy subjects with single doses. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
QHRD106 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
74 participants
Where
1 siteChina
Study dates
5 Jul 2021to 6 Jan 2023
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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy male or female subjects, male and female equally;
  • Aged between 18 and 50 at the time of screening (including boundary values); Male weight ≥50.0kg, female weight ≥45.0kg; All subjects had a body mass index (BMI) between 19 and 28kg/m2 (including boundary values);
  • Participate voluntarily and sign informed consent to complete the experiment according to the research protocol.

Who cannot join

  • Subjects who meet one of the following conditions will not be enrolled in the trial:
  • a person who is allergic to, or is allergic to, 2 or more drugs or foods, or is known to have a history of allergy to the test preparation and any of its components or related preparations;
  • Patients with a history of clinically serious diseases such as nervous system, blood circulatory system, digestive system, urinary system, respiratory system, immune system, endocrine system, malignant tumor, mental and metabolic abnormalities, or any clinically significant diseases judged by researchers to be in an active period or unstable state;
  • Based on vital signs (including sitting blood pressure, pulse, and body temperature), physical examination, 12-lead electrocardiogram examination, and laboratory examination (including routine blood routine, urine routine, blood biochemistry, and coagulation function), the investigator determined that the abnormality was clinically significant;
  • postural hypotension;
  • α1-antitrypsin deficiency;
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  • Patients with difficulty in venous blood collection;
  • People with a history of fainting needles and fainting blood;
  • A history of drug abuse within the last two years (including repeated and heavy use of various narcotic drugs and psychotropic substances for non-medical purposes);
  • Excessive smoking within 3 months before screening (average > 5 cigarettes/day) or unable to stop using any tobacco products during the test period or smokers within 48 hours before screening;
  • Excessive daily consumption of tea, coffee or caffeinated beverages (more than 8 cups per day, 1 cup =250mL) in the 3 months before screening;
  • alcoholics (i.e. men drinking more than 28 standard units per week, women drinking more than 21 standard units per week, 1 standard unit containing 14g of alcohol, such as 360mL beer or 45mL spirits with 40% alcohol or 150mL wine) or regular drinkers (i.e. more than 14 standard units per week) in the six months prior to screening;
  • Positive alcohol breath test (test result greater than 0.0mg/100mL);
  • Hepatitis B surface antigen (HBsAg), hepatitis C virus(HCV) antibody, syphilis antibody and human immunodeficiency virus(HIV) antibody test one or more positive;
  • Positive urine screening for drug abuse (including morphine, methamphetamine, ketamine, dimethylene dexamphetamine, tetrahydrocannabinol, cocaine);
  • Abnormal chest X-ray or CT findings with clinical significance;
  • Abdominal B-ultrasonography (liver, bile, pancreas, spleen and kidney) with abnormal results and clinical significance;
  • Severe acute bacterial, viral or fungal infection within 4 weeks prior to screening;
  • Patients who had used any protease drugs (such as chylase, indinavir sulfate, ritonavir, bortezomib, ixazomib citrate, etc.) within 4 weeks before screening;
  • Use of any prescription or over-the-counter drugs, as well as any functional vitamins or Chinese herbal products within 2 weeks prior to screening;
  • Blood donation or blood loss greater than 400mL within 3 months before screening (except physiological blood loss);
  • Vaccinated within 1 month before screening, or planned to be vaccinated during the study period and within 1 month after the study ends;
  • Those who had undergone surgery within 3 months prior to screening or planned to undergo surgery during the trial;
  • Participants who participated in any drug clinical trial as a subject within 3 months before enrollment;
  • have consumed a special diet (including grapefruit, chocolate, tea, cola, or any food or beverage containing caffeine, alcoholic beverage, or other food or beverage that affects the absorption, distribution, metabolism, or excretion of drugs) in the 48 hours prior to screening;
  • The subjects or their partners do not wish to use one or more non-drug contraceptive methods (such as total abstinence, condoms,contraceptive rings, ligation, etc.) for contraception during the trial period or have pregnancy plans within 3 months after the end of the study; Or screening women with positive pregnancy tests or breastfeeding women;
  • With magnetic resonance examination contraindications: metal implant, claustrophobia, etc.;
  • Other situations in which the investigator considers that participation in the trial may not be appropriate. -

Trial locations and contacts

1 site in 1 country.

China1 site

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008

Other trials in China

About this study

Official title: Phase I Clinical Study of Tolerability, Safety and Pharmacokinetics of QHRD106 Injection in Chinese Healthy Subjects With Single Doses

The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of QHRD106 early in Chinese healthy subjects with single doses.

Read the detailed description

Eight dose groups were initially set up. The experimental groups were increased from low to high dose according to the principle of increasing dose, and Placebo was added as the control group. All the selected subjects in the experimental group were given the drug once.

Being tested
QHRD106 Injection, placebo
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QHRD106 InjectionDrug

    Also called pegylated(PEG)-tissue kallikrein-1

    250IU~8400IU,pegylated(PEG)-tissue kallikrein-1

  • placeboDrug

    placebo

Study groups in NCT06388772
Study groupRoleWhat they receive
Part-A SAD in healthy subjects(Cohort 1-8)ExperimentalA randomized, double-blinded, placebo-controlled, single ascending dose (SAD) study in healthy male and female subjects. Subjects will receive QHRD106 by intramuscular-injection (im).
Receives: Drug: QHRD106 Injection
Part-B Healthy subjects SAD placeboExperimentalA randomized, double-blinded, placebo-controlled, single ascending dose (SAD) study in healthy male and female subjects. Subjects will receive placebo by intramuscular-injection (im).
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety as assessed by incidence, severity, and causality of adverse events

    The frequency and number of adverse events, adverse reactions and serious adverse

    Measured: Up to 36 days after final dose

  2. Plasma measurements of QHRD106

    The concentration of a single dose was measured at 8 different doses

    Measured: Up to 36 days after final dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2024
  2. Study start5 Jul 2021
  3. Primary completion22 Jul 2022
  4. Study completion6 Jan 2023

Resources

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
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06388772
Sponsor's protocol ID
HJG-CZQH-QHRD106
Status last verified
Jul 2024
First submitted
25 Apr 2024
Last updated
24 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Huang L, Sun R, Song H, Chen Z, Hong Y, Yang H, Zhang Y, Wei L, Fei F, Li J. The first-in-human study of QHRD106 functioning as a safe and effective long-acting kallikrein drug potentially aiding ischemic stroke. Expert Opin Investig Drugs. 2024 Dec;33(12):1257-1265. doi: 10.1080/13543784.2024.2430200. Epub 2024 Nov 19.

    PubMed 39545461

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing QHRD106 Injection in people with Acute Ischemic Stroke, run by Changzhou Qianhong Bio-pharma 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 3 inclusion and 28 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 24 Jul 2024. 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?

Safety as assessed by incidence, severity, and causality of adverse events (time frame: Up to 36 days after final dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06388772, which also lists 1 linked publication.

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 24 Jul 2024.

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