HealthyPhase 1NCT06423261
Safety, Tolerability, Pharmacokinetics and Immunogenicity Study of GB002 Recombinant Peptide Inhalation Solution in Healthy Subjects
A Phase 1 study testing GB002 Recombinant Peptide Inhalation Solution in people with Healthy, run by Zhejiang Echon Biopharm Limited at 1 site in China.
Trial summary
This trial is conducted in China. The purpose of this clinical trial is to evaluate the safety and tolerability, pharmacokinetic (PK) characteristics, and immunogenicity of single/multiple inhalation of different doses of GB002 recombinant peptide in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- GB002 Recombinant Peptide Inhalation Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 24 Aug 2023to 29 Jul 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chinese healthy subjects aged 18 years and above (including 18 years old), both male and female;
- Male weight ≥50kg, female weight ≥45kg, and body mass index (BMI) in the range of 19-26kg /m² (including the critical value), body mass index (BMI) = weight (kg)/height 2 (m²);
- Sign informed consent before the test, and fully understand the test content, process and possible adverse reactions;
- The subjects were able to maintain good communication with the investigators, and understood and complied with the requirements of the clinical trial.
Who cannot join
- Participants in any drug clinical trial or use of investigational drug within 3 months prior to the use of investigational drug;
- Have a history of respiratory disease, such as acute exacerbation of chronic obstructive pulmonary disease, pulmonary fibrosis, pulmonary hypertension, pulmonary hydroedema, pulmonary interstitial disease, bronchial asthma, paradoxical bronchospasm, or throat ulcers, edema, or edema, or have undergone throat, trachea/bronchus, or lung surgery, or within 4 weeks prior to the use of the study drug, Patients with a history of upper and lower respiratory tract infection or acute sinusitis caused by viruses or bacteria, which is considered clinically significant by researchers;
- Patients with a medical history of cardiovascular system, digestive system, endocrine system, urinary system, nervous system, hematology, immunology (including personal or family history of inherited immune deficiency), metabolic abnormalities, and researchers believe that the current clinical significance;
- Allergy to any of the ingredients of the drug, or a history of allergy to drugs, foods, pollen or other substances, in particular a known allergy to protein foods, or a history of respiratory allergic disease;
- Patients who cannot tolerate venipunctures or have a history of fainting needles and fainting blood;
- Patients who have undergone surgery within 6 months prior to the use of the investigational drug that researchers judge will affect drug absorption, distribution, metabolism, and excretion; Or have undergone surgical procedures within 4 weeks prior to the use of the investigational drug; Or plan to undergo surgical procedures during the study period;
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- Used any drug (including prescription drugs, over-the-counter drugs, Chinese herbs, health care products, etc.) within 14 days before the use of the experimental drug;
- Persons who have received the vaccine or live attenuated vaccine within 14 days prior to the use of the investigational product, or who plan to receive the vaccine during the trial period;
- People who donated blood or lost a large amount of blood (>400mL) within 3 months prior to the use of the investigational drug, received blood transfusions or used blood products, or intended to donate blood or blood components during or within 3 months after the end of the trial;
- Drug abusers or those who have used soft drugs (e.g., cannabis) or hard drugs (e.g., cocaine, PCP, etc.) within one year prior to the use of the investigatory drug;
- Smokers or smokers who smoked more than 5 cigarettes per day in the 3 months prior to the use of the experimental drug, or who could not stop using any tobacco products during the test period;
- Alcoholics or regular drinkers in the six months prior to the use of the experimental drug, i.e. drinking more than 14 units of alcohol per week (1 unit =360mL beer or 45mL spirits with 40% alcohol or 150mL wine); Or unwilling to stop drinking alcohol or any products containing alcohol during the trial;
- Those who consumed excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250mL) per day, or did not agree to stop drinking tea, coffee and/or caffeinated beverages during the study period;
- Eat any diet (including grapefruit or grapefruit products, dragon fruit, mango, grapefruit, orange, etc.) that may affect the metabolism of the drug in the body within 7 days prior to the use of the investigatory drug, or any other diet that the researcher considers to affect the absorption, distribution, metabolism or excretion of the drug, or do not agree to stop eating the above diet during the trial period;
- Those who have special requirements for diet and cannot comply with a unified diet;
- Subjects (or their partners) have pregnancy plans, sperm and egg donation plans, or do not wish to use one or more non-drug contraceptive methods (such as total abstinence, condoms, pregnancy avoidance rings, partner ligation, etc.) during the trial period to 3 months after the trial ends;
- Female subjects are pregnant or lactating women; Or had unprotected sex within 2 weeks prior to the use of the investigational drug; Use of oral contraceptives within 30 days prior to the use of the investigational drug or use of long-acting estrogen or progesterone injections or implants within 6 months prior to the use of the investigational drug;
- Patients with clinically significant abnormalities in physical examination, 12-lead electrocardiogram, vital signs (blood pressure, pulse, body temperature, SpO2), chest X-ray, laboratory examination, and pulmonary function examination (as determined by the clinician);
- Pulmonary function examination: FEV1 measured value /FEV1 estimated value ≤80% or FVC≤ 80% of the estimated value;
- Positive results of tobacco test;
- Positive urine screening test;
- Positive alcohol breath test;
- Failure to use the inhalant delivery device correctly or unqualified inhalant delivery training;
- Subjects may not be able to complete the study for other reasons or may have other reasons deemed inappropriate by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of GB002 Recombinant Polypeptide Inhalation Solution in a Randomized, Double-blind, Placebo-controlled, Dose-increasing Single and Multiple Administration in Chinese Healthy Adult Subjects.
This trial is conducted in China. The purpose of this clinical trial is to evaluate the safety and tolerability, pharmacokinetic (PK) characteristics, and immunogenicity of single/multiple inhalation of different doses of GB002 recombinant peptide in healthy subjects.
- Conditions
- Healthy
- Being tested
- GB002 Recombinant Peptide Inhalation Solution, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB002 Recombinant Peptide Inhalation SolutionDrug
Inhalation administration
PlaceboDrug
Inhalation administration
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose of GB002 Recombinant Peptide Inhalation Solution | Experimental | Each subject will receive one single administration of GB002 recombinant peptide inhalation solution. The dosage of each group is 0.625mg, 1.25mg, 2.5mg, 5.0mg,7.5mg, respectively. Receives: Drug: GB002 Recombinant Peptide Inhalation Solution; Drug: Placebo |
| Multiple Ascending Dose of GB002 Recombinant Peptide Inhalation Solution | Experimental | The subjects will receive multiple doses of GB002 recombinant peptide inhalation solution, administered twice a day for 6 consecutive days. The dosage for each group is 2.5mg, 5.0mg, and 6.5mg, respectively. Receives: Drug: GB002 Recombinant Peptide Inhalation Solution; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: Day 1 to Day 28
Secondary outcomes (2)
Plasma GB002 Recombinant Peptide concentrations
Measured: Day 1 to Day 7
Immunogenicity
Anti-drug antibody（ADA）and neutralizing antibody Nab
Measured: Day 14 and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start24 Aug 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion29 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Echon Biopharm Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423261
- Sponsor's protocol ID
- YKSW-GB002-R01
- Status last verified
- Apr 2025
- First submitted
- 30 Apr 2024
- Last updated
- 9 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of GB002 Recombinant Polypeptide Inhalation Solution in a Randomized, Double-blind, Placebo-controlled, Dose-increasing Single and Multiple Administration in Chinese Healthy Adult Subjects.
- ClinicalTrials.gov ID
- NCT06423261
- Acronym / sponsor ID
- YKSW-GB002-R01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Zhejiang Echon Biopharm LimitedIndustry (pharma, biotech, devices)
- Study start
- 24 Aug 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 29 Jul 2026 (estimated)
- First posted
- 21 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is conducted in China. The purpose of this clinical trial is to evaluate the safety and tolerability, pharmacokinetic (PK) characteristics, and immunogenicity of single/multiple inhalation of different doses of GB002 recombinant peptide in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose of GB002 Recombinant Peptide Inhalation Solution | Experimental | Drug: GB002 Recombinant Peptide Inhalation Solution, Drug: PlaceboEach subject will receive one single administration of GB002 recombinant peptide inhalation solution. The dosage of each group is 0.625mg, 1.25mg, 2.5mg, 5.0mg,7.5mg, respectively. |
| Multiple Ascending Dose of GB002 Recombinant Peptide Inhalation Solution | Experimental | Drug: GB002 Recombinant Peptide Inhalation Solution, Drug: PlaceboThe subjects will receive multiple doses of GB002 recombinant peptide inhalation solution, administered twice a day for 6 consecutive days. The dosage for each group is 2.5mg, 5.0mg, and 6.5mg, respectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chinese healthy subjects aged 18 years and above (including 18 years old), both male and female;
- Male weight ≥50kg, female weight ≥45kg, and body mass index (BMI) in the range of 19-26kg /m² (including the critical value), body mass index (BMI) = weight (kg)/height 2 (m²);
- Sign informed consent before the test, and fully understand the test content, process and possible adverse reactions;
- The subjects were able to maintain good communication with the investigators, and understood and complied with the requirements of the clinical trial.
Key exclusion criteria (24 listed)
- Participants in any drug clinical trial or use of investigational drug within 3 months prior to the use of investigational drug;
- Have a history of respiratory disease, such as acute exacerbation of chronic obstructive pulmonary disease, pulmonary fibrosis, pulmonary hypertension, pulmonary hydroedema, pulmonary interstitial disease, bronchial asthma, paradoxical bronchospasm, or throat ulcers, edema, or edema, or have undergone throat, trachea/bronchus, or lung surgery, or within 4 weeks prior to the use of the study drug, Patients with a history of upper and lower respiratory tract infection or acute sinusitis caused by viruses or bacteria, which is considered clinically significant by researchers;
- Patients with a medical history of cardiovascular system, digestive system, endocrine system, urinary system, nervous system, hematology, immunology (including personal or family history of inherited immune deficiency), metabolic abnormalities, and researchers believe that the current clinical significance;
- Allergy to any of the ingredients of the drug, or a history of allergy to drugs, foods, pollen or other substances, in particular a known allergy to protein foods, or a history of respiratory allergic disease;
- Patients who cannot tolerate venipunctures or have a history of fainting needles and fainting blood;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GB002 Recombinant Peptide Inhalation SolutionInhalation administration | Drug | Multiple Ascending Dose of GB002 Recombinant Peptide Inhalation Solution, Single Ascending Dose of GB002 Recombinant Peptide Inhalation Solution |
| PlaceboInhalation administration | Drug | Multiple Ascending Dose of GB002 Recombinant Peptide Inhalation Solution, Single Ascending Dose of GB002 Recombinant Peptide Inhalation Solution |
Primary outcome
Number of participants with adverse events
Time frame: Day 1 to Day 28
2 secondary outcomes
Plasma GB002 Recombinant Peptide concentrations
Time frame: Day 1 to Day 7
Immunogenicity
Time frame: Day 14 and Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GB002 Recombinant Peptide Inhalation Solution in people with Healthy, run by Zhejiang Echon Biopharm Limited 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 4 inclusion and 24 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: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of participants with adverse events (time frame: Day 1 to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2025.