A Study to Evaluate the Safety and Bridging PK Profile of FB825 for Single Subcutaneous Administration in Healthy Adults

NCT05952986 | Unknown Phase 1 FDA Drug

• 1 other identifier: FB825CLPK01
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, placebo-controlled, and double-blind study to evaluate the safety and bridging PK profile of FB825 for single SC administration in healthy adults.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (4)

• Incidence of adverse event

  Safety will be reported based on Protocol defined AEs. For the purpose of this protocol, an AE will be defined as any untoward medical occurrence in a subject during the study.

  24 months

• AUC0-inf

  Area under the concentration-time curve from time zero to infinity, (extrapolated) will be assessed

  19 months

• AUC0-t

  Area under the concentration-time curve from time zero until the last observed concentration will be assessed

  19 months

• Cmax

  Maximal observed concentration will be assessed

  19 months

Secondary Outcomes (10)

• absolute bioavailability factor

  19 months

• Tmax

  19 months

• T½ el

  19 months

• Kel

  19 months

• CL/F

  19 months

Study Arms (3)

cohort 1

EXPERIMENTAL

FB825 300 mg or placebo with single SC administration in 3:1 ratio

Drug: FB825 or Placebo in subcutaneous route

cohort 2

EXPERIMENTAL

FB825 450 mg or placebo with single SC administration in 3:1 ratio

Drug: FB825 or Placebo in subcutaneous route

cohort 3

EXPERIMENTAL

300 mg single IV administration

Drug: FB825 in intravenous route

Interventions

FB825 or Placebo in subcutaneous route DRUG

FB825 or placebo solution for SC injection

cohort 1; cohort 2

FB825 in intravenous route DRUG

FB825 solution for IV infusion

cohort 3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, nonsmoker (no use of tobacco or nicotine products within 3 months prior to screening), ≥18 and ≤55 years of age, with body mass index (BMI) ≥18.5 and ≤30.0 kg/m2 and body weight ≥50.0 kg.
• Healthy as defined by:
• the absence of clinically significant illness and surgery within 4 weeks prior to dosing.
• the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
• the Investigator judgment, based on clinical laboratory test results performed at screening.
• Female subjects of non-childbearing potential must be:
• post-menopausal (spontaneous amenorrhea for at least 12 months prior to dosing) with follicle-stimulating hormone (FSH) levels per laboratory standard; or
• surgically sterile at least 3 months prior to dosing.
• Sexually active female subjects of childbearing potential and non-sterile male subjects must be willing to use an acceptable contraceptive method for 167 days after dosing.
• Female subjects of childbearing potential who are sexually active with a non-sterile male partner (sterile male partners are defined as men vasectomized for at least 3 months prior to dosing) must be willing to use one of the following acceptable contraceptive methods for 167 days after dosing:
• simultaneous use of hormonal contraceptive or non-hormonal intrauterine device used for at least 4 weeks prior to dosing (must agree to use the same contraceptive for 167 days after dosing) and condom for the male partner;
• simultaneous use of diaphragm or cervical cap with spermicide and condom for the male partner, started at least 21 days prior to dosing;
• or total abstinence from heterosexual intercourse.
• Male subjects who are not vasectomized for at least 3 months prior to dosing and who are sexually active with a female partner of childbearing potential must be willing to use one of the following acceptable contraceptive methods for 167 days after dosing:
• simultaneous use of condom and hormonal contraceptive or non-hormonal intrauterine device used for at least 4 weeks prior to sexual intercourse for the female partner;

You may not qualify if:

• Any clinically significant abnormal finding at physical examination at screening.
• Clinically significant abnormal laboratory test results or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) types 1 and 2 antibodies at screening.
• The subject has one or more of the following laboratory abnormalities at screening:
• Hemoglobin ≤10.5 g/dL
• Platelet count ≤99999 /mm3
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 2 × upper limit of normal \[ULN\] or higher
• Lipase 1.5 × ULN or higher
• Serum creatinine 1.5 × ULN or higher
• Any other clinically significant laboratory abnormality as judged by the Investigator
• Positive pregnancy test or lactating female subject.
• Positive urine drug screen, urine cotinine test, or alcohol breath test on Day -1.
• Known allergic reactions to FB825 or other related drugs, or to any excipient in the formulation.
• Clinically significant ECG abnormalities or vital signs abnormalities at screening.
• History of risk factors for torsade de pointes syndrome.
• History of drug abuse within 1 year prior to screening or recreational use of soft drugs within 1 month or hard drugs within 3 months prior to screening.

Sponsors & Collaborators

• Oneness Biotech Co., Ltd.: lead

Study Sites (1)

Phase I center

Anaheim, California, 92801, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Injections, Subcutaneous

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

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: July 3, 2023
• First Posted: July 19, 2023
• Study Start: May 3, 2023
• Primary Completion: March 26, 2024
• Study Completion: March 26, 2024
• Last Updated: January 26, 2024

Record last verified: 2023-07

Locations

US (1)