Clinical trial NCT05125211: Safety,Tolerability,and Pharmacokinetics Profiles of GB001 Recombinant Peptide Spray in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Zhejiang Echon Biopharm Limited
Sponsor class: INDUSTRY
First posted: 2021-11-18
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. 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).
2. 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.
3. 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.
4. 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.

Exclusion Criteria:

1. Those allergic to GB001 peptide or any other drugs, or suffered from allergic disease or allergic constitution.
2. 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.
3. Subjects has obvious oral lesions or diseases, such as erosion of oral mucosa, ulcer or obvious periodontitis.
4. 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.
5. Subject who smoke more than 10 cigarettes per day or is unwilling to stop smoking whenever required for the trial procedure.
6. Subject with a history of drug abuse, or those with positive urine screening test for drug abuse.
7. 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.
8. Blood loss or blood donation more than 400 mL within 90 days prior to screening.
9. Received major surgery within 90 days prior to screening, or participated in any other drug/device clinical trial.
10. Pregnant or lactating women; or female subject of childbearing age have a positive serum pregnancy test result during the screening.
11. Subject with dizzy needle or difficulty in venous blood collection.
12. Subject unsuitable for the trial in the judgement of the investigator.

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Through the study completion, an average of 2 weeks
Secondary outcomes:
measure: Pharmacokinetics Characteristics， t½ of GB001 recombinant peptide
timeFrame: Up to 240 minutes after last dose
measure: Pharmacokinetics Characteristics , Cmax of GB001 recombinant peptide
timeFrame: Up to 240 minutes after last dose
measure: Pharmacokinetics Characteristics , Tmax of GB001 recombinant peptide
timeFrame: Up to 240 minutes after last dose
measure: Pharmacokinetics Characteristics , AUC of GB001 recombinant peptide
timeFrame: Up to 240 minutes after last dose
measure: Pharmacokinetics Characteristics , Vd of GB001 recombinant peptide
timeFrame: Up to 240 minutes after last dose
measure: Pharmacokinetics Characteristics , Ctrough of GB001 recombinant peptide
timeFrame: Up to 240 minutes after last dose
Other outcomes:
measure: Oral retention time
timeFrame: Up to 120 minute after first dose
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Feng Shao, MD
role: PRINCIPAL_INVESTIGATOR
References: