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

NCT05125211 | Active Not Recruiting Phase 1

• 1 other identifier: YK2019L01P-Ⅰ
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Pharmacokinetics Characteristics， t½ of GB001 recombinant peptide

  Up to 240 minutes after last dose

• Pharmacokinetics Characteristics , Cmax of GB001 recombinant peptide

  Up to 240 minutes after last dose

• Pharmacokinetics Characteristics , Tmax of GB001 recombinant peptide

  Up to 240 minutes after last dose

• Pharmacokinetics Characteristics , AUC of GB001 recombinant peptide

  Up to 240 minutes after last dose

• Pharmacokinetics Characteristics , Vd of GB001 recombinant peptide

  Up to 240 minutes after last dose

Other Outcomes (1)

• Oral retention time

  Up to 120 minute after first dose

Study Arms (3)

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.

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.

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.

Drug: GB001 recombinant peptide spray; Drug: Placebo

Interventions

GB001 recombinant peptide spray DRUG

administrated oral spray

Multiple Ascending Dose of GB001 recombinant peptide spray; Oral retention time test for a single dose; Single dose-escalation of GB001 recombinant peptide spray

Placebo DRUG

administrated oral spray

Multiple Ascending Dose of GB001 recombinant peptide spray; Single dose-escalation of GB001 recombinant peptide spray

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Those allergic to GB001 peptide or any other drugs, or suffered from allergic disease or allergic constitution.
• 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.
• 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.

Sponsors & Collaborators

• Zhejiang Echon Biopharm Limited: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing medical University

Nanjing, Jiangsu, 210029, China

Location

Study Officials

• Feng Shao, MD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2021
• First Posted: November 18, 2021
• Study Start: August 8, 2022
• Primary Completion: November 18, 2022
• Study Completion (Estimated): May 29, 2026
• Last Updated: April 9, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)