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

Sponsor
Zhejiang Echon Biopharm Limited (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05125211
Collaborator
(none)
90
Enrollment
1
Location
3
Arms
5
Anticipated Duration (Months)
18.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: GB001 recombinant peptide spray
  • Drug: Placebo
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Nov 20, 2021
Anticipated Primary Completion Date :
Apr 20, 2022
Anticipated Study Completion Date :
Apr 20, 2022

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. Incidence of adverse events [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

Secondary Outcome Measures

  1. Pharmacokinetics Characteristics, t½ of GB001 recombinant peptide [Up to 240 minutes after last dose]

    Apparent terminal phase half-life

  2. Pharmacokinetics Characteristics , Cmax of GB001 recombinant peptide [Up to 240 minutes after last dose]

    Maximum plasma concentration

  3. Pharmacokinetics Characteristics , Tmax of GB001 recombinant peptide [Up to 240 minutes after last dose]

    Time of maximum plasma concentration

  4. Pharmacokinetics Characteristics , AUC of GB001 recombinant peptide [Up to 240 minutes after last dose]

    Area under the plasma concentration versus time curve

  5. Pharmacokinetics Characteristics , Vd of GB001 recombinant peptide [Up to 240 minutes after last dose]

    Apparent distribution volume

  6. Pharmacokinetics Characteristics , Ctrough of GB001 recombinant peptide [Up to 240 minutes after last dose]

    Trough plasma concentration

Other Outcome Measures

  1. Oral retention time [Up to 120 minute after first dose]

    Oral retention time

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1The First Affiliated Hospital of Nanjing medical UniversityNanjingJiangsuChina210029

Sponsors and Collaborators

  • Zhejiang Echon Biopharm Limited

Investigators

  • Principal Investigator: Feng Shao, MD, The First Affiliated Hospital with Nanjing Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhejiang Echon Biopharm Limited
ClinicalTrials.gov Identifier:
NCT05125211
Other Study ID Numbers:
  • YK2019L01P-Ⅰ
First Posted:
Nov 18, 2021
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 18, 2021