Phase 1 study of ALC919

JRCT ID: jRCT2011220042

Registered date:03/03/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Alzheimers disease
• Date of first enrollment: 03/03/2023
• Target sample size: 40
• Study type: Interventional

Intervention(s)

(Single administration part)
Once a day, use a microporation device (Passport System porator and applicator) on the upper arm of the subject disinfected with alcohol swabs, etc., and after creating micropores in the skin, apply the dose set for each cohort. ALC919 or placebo formulation will be applied based on the results of randomization.
(Repeated administration part)
The above administration method is continued once a day for 7 days. The application site should be changed each time so that the application sites do not overlap each time.

Outcome(s)

Primary Outcome

safety
Presence or absence of adverse events, medically significant changes (vital signs), and laboratory test results (hematologic tests, Blood biochemical examination, urinalysis), skin findings, etc. will be evaluated by comparing the baseline (before administration of the study drug or the day before administration) and between groups.

Secondary Outcome

Pharmacokinetics
Evaluate changes in blood p3-Alcbeta9-19 concentration before and after administration of ALC919. Also estimate the maximum plasma concentration (Cmax), time to reach maximum plasma concentration (Tmax), area under the plasma concentration-time curve (AUC) and elimination half-life (t1/2) of p3-Alcbeta9-19.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 50age old
• Gender: Male

Include criteria

(1) Japanese healthy male volunteers
(2) Subjects with a weight of 50 kg or more and less than 85 kg and a BMI of 18.5 or more and less than 25.0 at the time of screening
(3) Those who are able to participate in all scheduled examinations of this clinical trial and complete the clinical trial
(4) Subjects who have received a sufficient explanation about the contents of this clinical trial and who have obtained their written consent
(5) Those who are 20 to 50 years old at the time of obtaining consent

Exclude criteria

(1) Subjects who have skin diseases (dermatitis, pigmentation abnormality, trauma, etc.) or skin abnormalities (eruption, atrophic skin, fragile skin, abnormally dry skin, etc.) that interfere with evaluation on the planned application site (upper arm) of the investigational drug
(2) Subjects who cannot secure the site where the investigational drug is to be applied due to body hair, subjects who have a tattoo or nevus on the site where the investigational drug is to be applied, or subjects whose skin findings may be difficult to evaluate due to sunburn, etc.
(3) Those who are suffering from atopic dermatitis or have a history of it
(4) Subjects who are known to have skin hypersensitivity to topical agents (including over-the-counter drugs) and tapes such as bandages
(5) Psychiatric, gastrointestinal, hepatic, renal, respiratory, endocrine, hematological, nervous, cardiovascular, congenital metabolic disorders, etc. that affect drug evaluation within 4 weeks prior to study drug administration Those with possible diseases
(6) Subjects who have a history of surgical treatment that may affect the pharmacokinetics of the study drug (e.g., liver resection, nephrectomy, resection of the gastrointestinal tract, etc.)
(7) Patients with a clinically significant disease requiring treatment within 8 weeks prior to study drug administration, or a history of clinically significant infection within 4 weeks prior to study drug administration
(8) Those who are currently participating in other clinical trials or those who have participated in other clinical trials and used investigational drugs or investigational devices within 3 months before obtaining informed consent
(9) Subjects who have used drugs within 14 days before administration of the study drug and who are judged by the investigator or subinvestigator to be unsuitable for this study, or who are expected to use drugs by the end of the last observation day
(10) Blood pressure, pulse rate, body temperature, or 12-lead electrocardiogram at the time of screening examination deviated from the reference range, and the investigator judged that the subject was clinically inappropriate for this study (orthostatic blood pressure, equal or more than 90 mmHg and equal or less than 140 mmHg. Diastolic, equal or more than 40 mmHg and equal or less than 90 mmHg. Orthopedic pulse rate, equal or more than 40 bpm and equal or less than 90 bpm. Axillary temperature, equal or more than 35.0 degreesand equal or less than 37.0 degrees. 12-lead ECG, Normal or clinical minor anomalies)
(11) Subjects who meet any of the following criteria in the clinical examination at the time of screening examination, and who are judged clinically unsuitable for this study by the investigator. In addition, the reference range of various tests shall be the reference range of the conducting medical institution or testing/measurement institution.
1) Hematological test: Those who deviate from the upper and lower limits of the reference range plus or minus 20 percent. However, as long as the white blood cell count is within the standard value, the individual value of the fraction does not matter
2) Blood biochemistry test: AST, ALT, creatinine (Cre) and serum electrolytes (Na, K, Cl, Ca, P) deviate from the reference range
For items other than the above, those who deviate from the upper and lower limits of the reference range plus or minus20 percent. However, items for which deviation from the lower limit is considered to be clinically insignificant (AST, ALT, gamma-GTP, T-Bil, ALP, LDH, BUN, Cre, UA, total cholesterol (T-Cho), neutral fat (TG)) does not set a lower limit.
3) Urinalysis: Those who deviate from the reference range for each qualitative test item
(12) Those with a history of drug or alcohol dependence or abuse. And those who have a positive drug test at screening
(13) Those who answered yes to question 4 or 5 regarding suicidal ideation on the Columbia Suicide Rating Scale (C-SSRS) at screening. or history of suicidal behavior at baseline within 6 months prior to screening.
(14) Those with a positive human immunodeficiency virus (HIV) test at screening
(15) Those who are positive for hepatitis B virus surface (HBs) antigen, hepatitis C virus (HCV) antibody, and syphilis qualitative reaction by screening test
(16) Subjects with a history of hypersensitivity to drugs, food allergies, or alcohol that may affect the conduct of the study
(17) Subjects who have difficulty in contraception from the administration of the study drug to the 28th day of administration of the study drug.
(18) Subjects who received a blood transfusion within 12 weeks before administration of the study drug, subjects who collected 400 mL or more of whole blood within 12 weeks, subjects who collected 200 mL or more of whole blood within 4 weeks, or blood component donation within 2 weeks. who went
(19) Employees of the medical institution, their family members, or persons in a dependent relationship with employees of the medical institution involved in the conduct of this study (e.g., spouses, parents, children, brothers and sisters), or compulsory consent who are likely to
(20) Others who are judged by the investigator, etc., to be unsuitable for this clinical trial

Related Information

• Primary Sponsor: Amano Toraji
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development