HealthyPhase 1NCT05125211
Safety,Tolerability,and Pharmacokinetics Profiles of GB001 Recombinant Peptide Spray in Healthy Subjects
A Phase 1 study testing GB001 recombinant peptide spray in people with Healthy, run by Zhejiang Echon Biopharm Limited at 1 site in China.
Trial summary
This trial is conducted in China. The aim of this clinical trial is to assess the safety , tolerability and pharmacokinetics profiles of GB001 by single ascending dose and multiple ascending doses in healthy subjects after topical buccal delivery. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- GB001 recombinant peptide spray
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 1 siteChina
- Study dates
- 8 Aug 2022to 29 May 2026
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males or females aged 18 to 45 years, with a body mass index(BMI) 19-26kg/m2 and body weight no less than 45 kg (female) or 50 kg (male).
- The results in the screening examinations (including general physical examination, vital signs, laboratory examinations, electrocardiogram, chest radiograph, etc.) are in the normal range, or are abnormal without clinical significance assessed by the investigator.
- Subjects and their sexual partners agree to take effective contraceptive measures during the study period and at least 3 days after the end of the study.
- Understanding and willing to comply strictly with the clinical trial protocol, complete all test procedures required in this trial, understand and sign informed consent form.
Who cannot join
- Those allergic to GB001 peptide or any other drugs, or suffered from allergic disease or allergic constitution.
- Any obvious clinical symptoms or abnormal test results with clinical significance suggested organ or system illness, unsuitable for inclusion in this trial in the investigator's judgement.
- Subjects has obvious oral lesions or diseases, such as erosion of oral mucosa, ulcer or obvious periodontitis.
- The weekly alcohol intake in 90 days before screening is more than 21 units (male) and more than 14 units (female) , or the subject is unwilling to stop drinking whenever required for the trial procedure.
- Subject who smoke more than 10 cigarettes per day or is unwilling to stop smoking whenever required for the trial procedure.
- Subject with a history of drug abuse, or those with positive urine screening test for drug abuse.
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- Subject who use of any other drugs within 30 days prior to screening, including prescription drugs, non-prescription drugs, biologicals, vitamins, minerals and nutritional supplements.
- Blood loss or blood donation more than 400 mL within 90 days prior to screening.
- Received major surgery within 90 days prior to screening, or participated in any other drug/device clinical trial.
- Pregnant or lactating women; or female subject of childbearing age have a positive serum pregnancy test result during the screening.
- Subject with dizzy needle or difficulty in venous blood collection.
- Subject unsuitable for the trial in the judgement of the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Nanjing medical University
Nanjing, Jiangsu, 210029
About this study
Official title: A PhaseⅠRandomised, Double-blind, Placebo-controlled, Study to Evaluate the Safety, Tolerability, and Pharmacokinetics Characteristics of the Oral Topical Use of GB001 Recombinant Peptide Spray in Chinese Healthy Adult Subjects
This trial is conducted in China. The aim of this clinical trial is to assess the safety , tolerability and pharmacokinetics profiles of GB001 by single ascending dose and multiple ascending doses in healthy subjects after topical buccal delivery.
- Conditions
- Healthy
- Being tested
- GB001 recombinant peptide spray, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB001 recombinant peptide sprayDrug
administrated oral spray
PlaceboDrug
administrated oral spray
| Study group | Role | What they receive |
|---|---|---|
| Single dose-escalation of GB001 recombinant peptide spray | Experimental | Each subject will receive one single administration of GB001 recombinant peptide. The dosage of each group is 0.054mg, 0.108mg, 0.216mg, 0.432mg and 0.864mg, respectively. Receives: Drug: GB001 recombinant peptide spray; Drug: Placebo |
| Oral retention time test for a single dose | Experimental | Each subject will receive one single administration of GB001 recombinant peptide. The dosage of the group is 0.108mg. Receives: Drug: GB001 recombinant peptide spray |
| Multiple Ascending Dose of GB001 recombinant peptide spray | Experimental | Each subject will be dosed with oral spray of GB001 recombinant peptide ten times per day for four days. GB001 recombinant peptide will be administrated, and the dosage of each group is 0.108mg, 0.216mg and 0.432mg, respectively. Receives: Drug: GB001 recombinant peptide spray; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
The number and the incidence of serious and non-serious adverse events observed in each treatment will be used to assess the safety and tolerability
Measured: Through the study completion, an average of 2 weeks
Secondary outcomes (6)
Pharmacokinetics Characteristics， t½ of GB001 recombinant peptide
Apparent terminal phase half-life
Measured: Up to 240 minutes after last dose
Pharmacokinetics Characteristics , Cmax of GB001 recombinant peptide
Maximum plasma concentration
Measured: Up to 240 minutes after last dose
Pharmacokinetics Characteristics , Tmax of GB001 recombinant peptide
Time of maximum plasma concentration
Measured: Up to 240 minutes after last dose
Pharmacokinetics Characteristics , AUC of GB001 recombinant peptide
Area under the plasma concentration versus time curve
Measured: Up to 240 minutes after last dose
Pharmacokinetics Characteristics , Vd of GB001 recombinant peptide
Apparent distribution volume
Measured: Up to 240 minutes after last dose
Pharmacokinetics Characteristics , Ctrough of GB001 recombinant peptide
Trough plasma concentration
Measured: Up to 240 minutes after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start8 Aug 2022
- Primary completion18 Nov 2022
- Study completion29 May 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
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Echon Biopharm Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Feng Shao, MD, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125211
- Sponsor's protocol ID
- YK2019L01P-Ⅰ
- Status last verified
- Apr 2024
- First submitted
- 24 Oct 2021
- 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
- A PhaseⅠRandomised, Double-blind, Placebo-controlled, Study to Evaluate the Safety, Tolerability, and Pharmacokinetics Characteristics of the Oral Topical Use of GB001 Recombinant Peptide Spray in Chinese Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05125211
- Acronym / sponsor ID
- YK2019L01P-Ⅰ
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Zhejiang Echon Biopharm LimitedIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 18 Nov 2022 (actual)
- Study completion
- 29 May 2026 (estimated)
- First posted
- 18 Nov 2021 (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 aim of this clinical trial is to assess the safety , tolerability and pharmacokinetics profiles of GB001 by single ascending dose and multiple ascending doses in healthy subjects after topical buccal delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single dose-escalation of GB001 recombinant peptide spray | Experimental | Drug: GB001 recombinant peptide spray, Drug: PlaceboEach subject will receive one single administration of GB001 recombinant peptide. The dosage of each group is 0.054mg, 0.108mg, 0.216mg, 0.432mg and 0.864mg, respectively. |
| Oral retention time test for a single dose | Experimental | Drug: GB001 recombinant peptide sprayEach subject will receive one single administration of GB001 recombinant peptide. The dosage of the group is 0.108mg. |
| Multiple Ascending Dose of GB001 recombinant peptide spray | Experimental | Drug: GB001 recombinant peptide spray, Drug: PlaceboEach subject will be dosed with oral spray of GB001 recombinant peptide ten times per day for four days. GB001 recombinant peptide will be administrated, and the dosage of each group is 0.108mg, 0.216mg and 0.432mg, respectively. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males or females aged 18 to 45 years, with a body mass index(BMI) 19-26kg/m2 and body weight no less than 45 kg (female) or 50 kg (male).
- The results in the screening examinations (including general physical examination, vital signs, laboratory examinations, electrocardiogram, chest radiograph, etc.) are in the normal range, or are abnormal without clinical significance assessed by the investigator.
- Subjects and their sexual partners agree to take effective contraceptive measures during the study period and at least 3 days after the end of the study.
- Understanding and willing to comply strictly with the clinical trial protocol, complete all test procedures required in this trial, understand and sign informed consent form.
Key exclusion criteria (12 listed)
- Those allergic to GB001 peptide or any other drugs, or suffered from allergic disease or allergic constitution.
- Any obvious clinical symptoms or abnormal test results with clinical significance suggested organ or system illness, unsuitable for inclusion in this trial in the investigator's judgement.
- Subjects has obvious oral lesions or diseases, such as erosion of oral mucosa, ulcer or obvious periodontitis.
- The weekly alcohol intake in 90 days before screening is more than 21 units (male) and more than 14 units (female) , or the subject is unwilling to stop drinking whenever required for the trial procedure.
- Subject who smoke more than 10 cigarettes per day or is unwilling to stop smoking whenever required for the trial procedure.
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 |
|---|---|---|
| GB001 recombinant peptide sprayadministrated oral spray | Drug | Multiple Ascending Dose of GB001 recombinant peptide spray, Oral retention time test for a single dose, Single dose-escalation of GB001 recombinant peptide spray |
| Placeboadministrated oral spray | Drug | Multiple Ascending Dose of GB001 recombinant peptide spray, Single dose-escalation of GB001 recombinant peptide spray |
Primary outcome
Incidence of adverse events
Time frame: Through the study completion, an average of 2 weeks
The number and the incidence of serious and non-serious adverse events observed in each treatment will be used to assess the safety and tolerability
6 secondary outcomes
Pharmacokinetics Characteristics， t½ of GB001 recombinant peptide
Time frame: Up to 240 minutes after last dose
Pharmacokinetics Characteristics , Cmax of GB001 recombinant peptide
Time frame: Up to 240 minutes after last dose
Pharmacokinetics Characteristics , Tmax of GB001 recombinant peptide
Time frame: Up to 240 minutes after last dose
Pharmacokinetics Characteristics , AUC of GB001 recombinant peptide
Time frame: Up to 240 minutes after last dose
Pharmacokinetics Characteristics , Vd of GB001 recombinant peptide
Time frame: Up to 240 minutes after last dose
Pharmacokinetics Characteristics , Ctrough of GB001 recombinant peptide
Time frame: Up to 240 minutes after last dose
Results and safety
Results are not available in the source record.
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.
Feng Shao, MD principal investigator
The First Affiliated Hospital with Nanjing Medical University
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 GB001 recombinant peptide spray 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 12 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: status not confirmed, 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?
Results are not available in the source record.
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?
Incidence of adverse events (time frame: Through the study completion, an average of 2 weeks). 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.