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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: GB001 recombinant peptide spray; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single dose-escalation of GB001 recombinant peptide spray; 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.	Drug: GB001 recombinant peptide spray; administrated oral spray; Drug: Placebo; administrated oral spray
Experimental: Oral retention time test for a single dose; Each subject will receive one single administration of GB001 recombinant peptide. The dosage of the group is 0.108mg.	Drug: GB001 recombinant peptide spray; administrated oral spray
Experimental: Multiple Ascending Dose of GB001 recombinant peptide spray; 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.	Drug: GB001 recombinant peptide spray; administrated oral spray; Drug: Placebo; administrated oral spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics Characteristics， t½ of GB001 recombinant peptide	Apparent terminal phase half-life	Up to 240 minutes after last dose
Pharmacokinetics Characteristics , Cmax of GB001 recombinant peptide	Maximum plasma concentration	Up to 240 minutes after last dose
Pharmacokinetics Characteristics , Tmax of GB001 recombinant peptide	Time of maximum plasma concentration	Up to 240 minutes after last dose
Pharmacokinetics Characteristics , AUC of GB001 recombinant peptide	Area under the plasma concentration versus time curve	Up to 240 minutes after last dose
Pharmacokinetics Characteristics , Vd of GB001 recombinant peptide	Apparent distribution volume	Up to 240 minutes after last dose
Pharmacokinetics Characteristics , Ctrough of GB001 recombinant peptide	Trough plasma concentration	Up to 240 minutes after last dose

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral retention time	Oral retention time	Up to 120 minute after first dose

Collaborators and Investigators

• Sponsor: Zhejiang Echon Biopharm Limited
• Investigators: Principal Investigator: Feng Shao, MD, The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2022
• Primary Completion (Actual): November 18, 2022
• Study Completion (Estimated): May 29, 2026

Study Registration Dates

• First Submitted: October 24, 2021
• First Submitted That Met QC Criteria: November 7, 2021
• First Posted (Actual): November 18, 2021

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: YK2019L01P-Ⅰ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No