A Bridging Study of FB2001 in Healthy Subjects

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

In the first human clinical trial conducted in the United States, single and multiple dosing of FB2001 in multiple dose groups was partially completed，and FB2001 demonstrated good safety and tolerability. The bridge study of FB2001 will be conducted in China to evaluated the safety and PK of FB2001 in healthy Chinese population. This is a randomized, double-blind, placebo-controlled study of single and multiple dosing, with multiple dosing once daily for 5 days.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Frontier Biotechnologies Inc.

Criteria

Inclusion Criteria:

1. Male or female adults who are between 18 and 60 years old inclusive

2. Weigh at least 45kg, with a BMI of 19 to 30 kg/m2 inclusive

3. No serious underlying disease which would adversely affect the study conduct and data interpretation per the investigator

4. Subjects should have normal (or abnormal but not clinically significant) laboratory results per the PI's judgement, including complete blood count, biochemistry, coagulation indices and urinalysis

5. Subjects should have a normal (or abnormal but not clinically significant) ECG and chest X-ray at screening

6. Current non-smokers and those who have not smoked within the last 6 months. This includes the use of cigarettes, e-cigarettes, and nicotine replacement products.

7. Female subjects should have negative results in serum pregnancy test at screening and negative urine pregnancy test at admission.

8. Subjects of reproductive age and their partners agree to take effective contraceptive measures within 3 months after administration. Note:

• No sex life,

• Female barrier method: cervical cap or cervical cap with spermicide

• Tubal sterilization

• Male subject or partner undergo vasectomy

• Hormonal contraceptives

• Levonorgestrel implants

• Progesterone injection

• Oral contraceptives (combination or progesterone alone)

• Vaginal contraceptive ring

• Transdermal contraceptive patch

9. Willing to cooperate and be able to participate in the study, comply with all requirements of the program, and sign informed consent. .

Exclusion Criteria:

1. HIV antibody positive;

2. HBsAg positive;

3. HCV antibody positive;

4. Treponema pallidum antibody is positive;

5. History of tuberculosis or lung disease;

6. The subject has severe cardiovascular disease, neurological disease, hematological disease, infectious disease, mental disorder, liver disease, gastrointestinal disease, lung disease, endocrine disease, immune disease or kidney disease, or has a history of the above diseases, or other symptoms known to interfere with the absorption, distribution, metabolism, or excretion of the medicine, or other conditions that the investigator believes will increase the risk of the subject and might interfere with the study conduct and results interpretation;

7. Female subjects who are pregnant, lactating or have pregnancy plans in the 3 months after their study completion;

8. Subjects who participated in any other clinical study within 3 months prior to screening;

9. Subjects with known allergic reactions to the study drug or its excipients;

10. Blood donation or blood loss ≥400mL within 3 months prior to drug administration, or blood transfusion; Blood donation (including component blood donation) or blood loss ≥200mL within 1 month before drug administration;

11. Any drugs that inhibit or induce drug metabolism enzymes in the liver (e.g., inducers -- barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; Inhibitors - SSRI antidepressants, cimetidine, diltiazem macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines); Or any prescription, over-the-counter, or herbal medicines other than those mentioned above within 14 days prior to the administration of the study drug;

12. Alcoholics or regular drinkers in the 3 months prior to the study，or a positive screen for alcohol or drugs of abuse at screening or admission

13. Use of any medication, including prescription or over the counter, vitamins, herbal and/or mineral supplements, dietary supplements (and/or grape fruit juice) within 14 days prior to the first treatment or during the trial, which in the opinion of the investigator may influence the trial results or the safety of the subjects

14. Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.