Safety,Tolerability,and Pharmacokinetics Profiles of GB001 Recombinant Peptide Spray in Healthy Subjects

Healthy Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05125211
• Other study ID #: YK2019L01P-?
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: August 8, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: December 2022
• Source: Zhejiang Echon Biopharm Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: April 1, 2023
• Est. primary completion date: November 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• GB001 recombinant peptide spray
administrated oral spray
• Placebo
administrated oral spray

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanjing medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Echon Biopharm Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Oral retention time	Oral retention time	Up to 120 minute after first dose
Primary	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	Through the study completion, an average of 2 weeks
Secondary	Pharmacokinetics Characteristics, t½ of GB001 recombinant peptide	Apparent terminal phase half-life	Up to 240 minutes after last dose
Secondary	Pharmacokinetics Characteristics , Cmax of GB001 recombinant peptide	Maximum plasma concentration	Up to 240 minutes after last dose
Secondary	Pharmacokinetics Characteristics , Tmax of GB001 recombinant peptide	Time of maximum plasma concentration	Up to 240 minutes after last dose
Secondary	Pharmacokinetics Characteristics , AUC of GB001 recombinant peptide	Area under the plasma concentration versus time curve	Up to 240 minutes after last dose
Secondary	Pharmacokinetics Characteristics , Vd of GB001 recombinant peptide	Apparent distribution volume	Up to 240 minutes after last dose
Secondary	Pharmacokinetics Characteristics , Ctrough of GB001 recombinant peptide	Trough plasma concentration	Up to 240 minutes after last dose