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

Zhejiang Echon Biopharm

Status and phase: Active, not recruiting; Phase 1

Conditions: Healthy

Treatments: Drug: GB001 recombinant peptide spray; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05125211

YK2019L01P-Ⅰ

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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91 participants in 3 patient groups

Single dose-escalation of GB001 recombinant peptide spray

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: GB001 recombinant peptide spray

Oral retention time test for a single dose

Experimental group

Description:

Each subject will receive one single administration of GB001 recombinant peptide. The dosage of the group is 0.108mg.

Treatment:

Drug: GB001 recombinant peptide spray

Multiple Ascending Dose of GB001 recombinant peptide spray

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: GB001 recombinant peptide spray