AzTrials
AzTrials

Atopic DermatitisPhase 1NCT05952986

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

A Phase 1 study testing FB825 in intravenous route in people with Atopic Dermatitis, run by Oneness Biotech Co., Ltd. at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Atopic Dermatitis
What is being tested?
FB825 in intravenous route
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
22 participants
Where
1 siteUnited States
Study dates
3 May 2023to 26 Mar 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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:
Show all 20Show fewer
  • 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;
  • simultaneous use of condom and a diaphragm or cervical cap with spermicide for the female partner;
  • or total abstinence from heterosexual intercourse.
  • Male subjects (including men who have had a vasectomy) with a pregnant partner must agree to use a condom for 167 days after dosing.
  • Male subjects must be willing not to donate sperm for 167 days after dosing.
  • Able to understand the study procedures and provide signed informed consent form (ICF) to participate in the study.

Who cannot join

  • 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
Show all 27Show fewer
  • 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.
  • History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 7 units for women or 14 units for men of alcohol per week (1 unit = 340 mL of beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%).
  • The subject lives in, has recently (within 6 months of screening) lived in or traveled to, or is planning to travel to, an area where parasitic infections are endemic. In cases of uncertainty, it can be judged by the Investigator prior to enrolling the subject in the study.
  • The subject has clinically relevant, currently active or underlying gastrointestinal, cardiovascular, nervous system, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, immunological, endocrine, or infectious disease. This includes subjects with asthma, eosinophilic disease of any origin, IgE abnormalities, or urticaria of all types.
  • The subject has a clinically significant history, as determined by the Investigator, of drug allergies or hypersensitivity such as, but not limited to, sulfonamides and penicillins, or a drug allergy witnessed in a previous study with experimental drugs.
  • The subject has any history of a previous anaphylactic reaction.
  • The subject has used a concomitant medication, including over-the-counter (OTC) products, herbal medications, dietary supplements, and vitamin supplements within 14 days before Day -1.
  • The subject has received any immunoglobulin products or blood products within 6 months of Day -1 or has any previous participation in a clinical research study involving the administration of FB825.
  • Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days (or 5 half-lives, whichever is longer) prior to Day -1, administration of a biological product in the context of a clinical research study within 90 days prior to Day -1, or concomitant participation in an investigational study involving no drug or device administration.
  • Donation of plasma within 2 months prior to dosing or donation or loss of 500 mL or more of whole blood within 2 months prior to dosing.
  • Subject has the presence of tattoos, sunburn, or other skin disturbances on injection/infusion site which may interfere with a medical assessment of the injection/infusion site both prior to and following dosing.
  • The subject is a member of the site study team.
  • The subject has any condition that, in the opinion of the Investigator, would compromise the study or the well-being of the subject or prevent the subject from meeting or performing study requirements.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Phase I center

    Anaheim, California, 92801

Other trials in United States

About this study

Official title: A Randomized, Placebo-Controlled, Double-Blind, Phase I Study to Evaluate the Safety and Bridging Pharmacokinetics Profile of FB825 for Single Subcutaneous Administration in Healthy Adults

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.

Being tested
FB825 or Placebo in subcutaneous route, FB825 in intravenous route
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FB825 or Placebo in subcutaneous routeDrug

    FB825 or placebo solution for SC injection

  • FB825 in intravenous routeDrug

    FB825 solution for IV infusion

Study groups in NCT05952986
Study groupRoleWhat they receive
cohort 1ExperimentalFB825 300 mg or placebo with single SC administration in 3:1 ratio
Receives: Drug: FB825 or Placebo in subcutaneous route
cohort 2ExperimentalFB825 450 mg or placebo with single SC administration in 3:1 ratio
Receives: Drug: FB825 or Placebo in subcutaneous route
cohort 3Experimental300 mg single IV administration
Receives: Drug: FB825 in intravenous route

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 24 months

  2. AUC0-inf

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

    Measured: 19 months

  3. AUC0-t

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

    Measured: 19 months

  4. Cmax

    Maximal observed concentration will be assessed

    Measured: 19 months

Secondary outcomes (10)

  1. absolute bioavailability factor

    Absolute bioavailability factor will be assessed

    Measured: 19 months

  2. Tmax

    Time of observed Cmax will be assessed

    Measured: 19 months

  3. T½ el

    Elimination half-life will be assessed

    Measured: 19 months

  4. Kel

    Elimination rate constant will be assessed

    Measured: 19 months

  5. CL/F

    Apparent clearance (for SC administration) will be assessed

    Measured: 19 months

  6. Vd/F

    Apparent volume of distribution (for SC administration) will be assessed

    Measured: 19 months

  7. CL

    Total body clearance (for IV infusion) will be assessed

    Measured: 19 months

  8. Vd

    Volume of distribution (for IV infusion) will be assessed

    Measured: 19 months

  9. Residual area

    Calculated as 100*(1- (AUC0-last / AUC0-inf))

    Measured: 19 months

  10. The effect of FB825 in immunogenicity

    Immunogenicity will be reported based on anti-drug antibody concentration.

    Measured: 19 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2023
  2. Study start3 May 2023
  3. Primary completion26 Mar 2024 (estimated)
  4. Study completion26 Mar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05952986
Sponsor's protocol ID
FB825CLPK01
Status last verified
Jul 2023
First submitted
3 Jul 2023
Last updated
26 Jan 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FB825 in intravenous route in people with Atopic Dermatitis, run by Oneness Biotech Co., Ltd. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse event (time frame: 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05952986.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in