A CLINICAL PHARMACOLOGY STUDY TO EVALUATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF NXT007 WITH A NEW PREPARATION METHOD IN HEALTHY JAPANESE MALE ADULTS

JRCT ID: jRCT2031220050

Registered date:29/04/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Hemophilia A
• Date of first enrollment: 31/05/2022
• Target sample size: 30
• Study type: Interventional
• Intervention(s): NXT007 with a new preparation method: Single subcutaneous administration of several dose of NXT007 with a new preparation method

Outcome(s)

Primary Outcome

Safety, Phamacokinetics, Phamacodynamics
Pharmacokinetic endpoints
Plasma NXT007 levels

Pharmacodynamic endpoints
- Activated partial thromboplastin time (aPTT)
- Thrombin generation
- Plasma blood coagulation factor IX (FIX) levels.
- Plasma blood coagulation factor X (FX) levels.

Safety end point
- Frequency and Severity of Adverse Events Including Serious Adverse Events
- Incidence of laboratory abnormalities
- Frequency of abnormal vital signs and abnormal ECG parameters
- Cytokine

Secondary Outcome

Other
Immunogenicity endpoint: Frequency of occurrence of anti-drug Abs (ADAs) against NXT007 with a new preparation method

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 44age old
• Gender: Male

Include criteria

Signed ICF
Able to comply with the study protocol, in the investigators judgment
Male sex
For men who are not surgically sterile: agreement to remain abstinent (refrain from heterosexual intercourse) or use condoms, and agreement to refrain from donating sperm, as defined below:
- With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 5 half-lives or 12 months after the last dose of NXT007, whichever is longer to avoid exposing the embryo. Men must refrain from donating sperm during this same period.
-The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the HV/patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception
Japanese race/ethnicity
Japanese race/ethnicity
Age =>20 and <45 years
BMI at screening: (Body weight [kg]/height [m]2) =>18.5 to <25.0
Absence of evidence of any active or chronic disease following a detailed medical and surgical history and complete physical examination, vital signs, 12-lead ECG, and laboratory tests

Exclude criteria

Previous or current history of drug- or alcohol-dependence
Previous or concomitant TE disease such as DVT, or signs of TE disease or TMA
Protein C activity (chromogenic assay), protein S free antigen, or antithrombin III activity levels below the lower limit of the reference range at screening
History of clinically significant allergy (anaphylactic shock or anaphylactoid symptoms)
Previous or concomitant autoimmune or connective tissue disease
Previous or concomitant malignancy or leukemia
History of hypersensitivity associated with globulin preparations
Received or planned to receive a live vaccine within 4 weeks before the start of the study drug administration
Planned surgery (including tooth extraction) during the study period
Participated in another clinical study within 4 weeks before screening, or within 5 half-lives of the investigational product, whichever is longer
Clinically significant ECG abnormalities at screening such as the following:
-The average QT interval with Fridericias correction of triplicate-measurements in supine position at 10-minute rest >450 msec.
-Bradycardia at rest (average heart rate < 40 bpm)
-Tachycardia at rest (average heart rate >100 bpm)
-Other clinically significant abnormalities in ECG
Any family history of congenital long QT syndrome or known congenital arrhythmiarespiratory, circulatory, endocrine, hematological, gastrointestinal, immune, psychological/nervous system, renal, hepatic, or allergic disorder
Family history of TE disorder such as serious DVT
Use or planned use of other drugs (i.e., prescription or over-the-counter drugs) within 2 weeks before the start of study drug administration (provided, however, that non-systemic topical antiseptics and ophthalmic solutions not affecting the PK or safety of the study drug will be permitted)
Blood draw of 200 mL within 4 weeks or 400 mL within 12 weeks prior to screening (e.g., blood donations), annual total blood draw volume (including blood drawn for this study) exceeding 1200 mL, or blood component donation within 2 weeks prior to screening
FVIII activity=>120 IU/dL at screening
Positive screening result for HIV antigen/antibodies, HBs antigen, or HCV antibodies. HVs who showed HBs antigen positive due to vaccination against hepatitis B are eligible
Evidence of infection at screening
Abnormal clinical findings at screening
Prior treatment with antibody preparations (commercially available or investigational)
Any other reason that, in the judgment of the investigator, would render the subject unsuitable for study participation

Related Information

• Primary Sponsor: Takehiko Sambe