A Study of FB1003 in Healthy Subject

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Escalating Single and Multiple Doses of FB1003 in the Healthy Subjects

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06343714
• Other study ID #: FB1003-04-101
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 3, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2024
• Source: 4B Technologies Limited
• Contact: Study Director
• Phone: +86 10 53650709
• Email: quan.q.pan[@]4btechnologies.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate safety and tolerability of FB1003 when given subcutaneously to healthy participants. Blood tests will be done to examine blood exposure, concentration and half-life of FB1003 following administrations. For each participant, the study will last up to about 12 weeks for single ascending dose part, and 18 weeks for multiple ascending dose part, including screening.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Male or female subjects who, at the time of signing the informed consent form (ICF), are between 18 and 55 years of age (inclusive).

• The subject is capable of understanding and complying with protocol requirements

• Subjects in good health based on pre-study medical history, physical examinations, vital signs, abdominal ultrasound, 12-lead ECGs, clinical laboratory tests.

• The subject weighs at least 45 kg and has a body mass index between 18 and 32 kg/m2 (inclusive).

• Must be capable of giving signed informed consent as described which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

• Women not of childbearing potential. OR must agree to use a double barrier highly effective method of contraception from the beginning of screening until at least 90 days after the last dose of study intervention.

Exclusion Criteria:

• Active or history of serious mental illness or psychiatric disorder, including but not limited to schizophrenia, bipolar disorder, or major depressive disorder, which require current medical intervention.

• Subject has abnormal screening or Check-in (D-1) laboratory values that suggest a clinically significant underlying disease or subject has the following lab abnormalities: alanine transferase (ALT) and/or aspartate transaminase (AST) >1.5 upper limit of normal (ULN).

• History of autonomic neuropathy, or diabetic neuropathy, or evidence of autonomic neuropathy, or presence of clinically relevant peripheral neuropathy.

• Resting heart rate of <50 or >100 beats per minute (not on ECG).

• History or evidence at screening of heart block.

• History of myocardial infarction, acute coronary syndromes, or cerebrovascular accident within 12 months prior to the screening visit.

• Human immunodeficiency virus (HIV), hepatitis B, or hepatitis C positive by serological testing at the screening visit.

• History or presence of malignancy within 5 years prior to screening, except subjects who have been treated successfully with no recurrence of basal or squamous cell carcinoma of the skin (<1 year), in situ cervical cancer, or in situ ductal breast cancer.

• Women of reproductive potential who have a positive serum pregnancy test result at the screening visit, or a positive urine pregnancy test result at the baseline visit (D-1), or who do not have their pregnancy test results on D-1.

• Subject has donated or lost 400 mL or more of his or her blood volume (including plasmapheresis) or had a transfusion of any blood product within 30 days prior to first dose of study intervention.

• Clinically significant illness within seven days before the first dose of the study intervention.

• History of multiple drug allergies or history of allergic reaction to the monoclonal antibody.

• History of severe intolerance to SC injection (minor reactions are permitted, e.g., localized swelling or redness).

• Significant concomitant illness or any medical or surgical condition, such as, but not limited to, cardiac, renal, neurological, endocrinological, gastrointestinal, hepatic, metabolic or lymphatic disease that would adversely affect the subject's participation in this study or interpretation of safety/PK data.

• Dosing with another investigational drug or therapy within 30 days or at least 5 half-lives of the investigational drug, whichever is longer.

• Systolic blood pressure (SBP) >140 mmHg and/or diastolic blood pressure (DBP) >90 mmHg after 5 minutes of resting in a seated position, unless determined by the Investigator to be not clinically relevant and well controlled with medications.

• Pregnant or breast-feeding women.

• Any conditions which would make the subject unsuitable for enrollment or could interfere with the subject's participation in or completion of the study in the opinion of the Investigator.

• Consume more than 14 (female) or 21 (male) units of alcohol per week (unit: 1 glass of wine (125 mL) = 1 measure of spirits = ½ pint of beer) within the 12 months before screening or positive screen for alcohol abuse.

• Smoking >4 cigarettes (or an equivalent amount of any other nicotine-containing product) per day within 30 days before screening.

• History or clinical evidence of drug abuse within the 12 months before screening or positive screen for drug abuse. Drug abuse is defined as compulsive, repetitive, and/or chronic use of drugs or other substances with or without problems related to their use and/or when stopping or a dose reduction will lead to withdrawal symptoms.

• Have received a live and/or non-live vaccine (including COVID) within 28 days prior to dosing or intend to receive a vaccine during the study period or at least 56 days after the last dose of IP.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• FB1003
Subcutaneous (SC) injection
• Placebo
Subcutaneous (SC) injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
4B Technologies Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint in the study is the incidence and severity of treatment emergent adverse events (TEAEs) in participants treated with FB1003 or placebo.	The percentages of subjects experiencing AEs will be calculated.	Baseline to end of study, SAD up to 56 days and MAD up to 84 days.
Secondary	FB1003 serum concentrations over time	The concentration of FB1003 will be evaluated.	Baseline to end of study, SAD up to 56 days and MAD up to 84 days.
Secondary	PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC0-8) of FB1003	AUC0-8 of FB1003 will be evaluated. The unit of measure is hour*microgram per milliliter (hr*mcg/mL).	Baseline to end of study, SAD up to 56 days and MAD up to 84 days.
Secondary	Presence of anti-FB1003 antibodies over time	The percentage of subjects testing positive for ADA will be calculated.	Baseline to end of study, SAD up to 56 days and MAD up to 84 days)