臨床研究等提出・公開システム

A phase I trial to evaluate the safety, tolerability and pharmacokinetics of RBM-007 administered subcutaneously in healthy volunteers

A Phase I trial in healthy adult volunteers

24

Healthy adult male

The investigational product was administered to 24 enrolled subjects, and 24 subjects completed the study.

One SAE (acute anaphylactic reaction) occurred in 1 subject who received RBM-007 at a single dose of 1.0 mg/kg, but the SAE resolved with proper medication.

The safety and tolerability of subcutaneous administration of RBM-007 at doses ranging from 0.1 to 0.6 mg/kg up to twice at weekly or biweekly intervals were not of particular concern.

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In a phase I study of RBM-007 in healthy adult males, the safety and tolerability of subcutaneous administration of RBM-007 at doses ranging from 0.1 to 0.6 mg/kg up to twice at weekly or biweekly intervals were not of particular concern, and pharmacokinetic data for Phase II study were obtained in this study.

No

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RIBOMIC Inc.

3-16-13 Shirokanedai, Minato-ku, Tokyo

n.ikegami@ribomic.com

RIBOMIC Inc.

3-16-13 Shirokanedai, Minato-ku, Tokyo

+81-3-3440-3303

n.ikegami@ribomic.com

completed

July. 01, 2020

Interventional

This is a open label, unblinded, non-comparative Phase I study.

other

1

(1)
Is willing and able to provide written and signed informed consent by himself, after receiving explanation of the purpose and contents of this study in writing
(2)
Is healthy male Japanese aged 20 to 45 years old, both inclusive
(3)
Has a body weight of 50 kg or above
(4)
Has body mass index (BMI) between 18.5 to 25.0 kg/m2, exclusive of 25.0
(5)
Is in generally good health based on medical history, physical examination, clinical laboratory tests and so on
(6)
Has azoospermia, vasectomized or consented to use appropriate contraception methods (combination of 2 methods, such as use of condoms and spermicides) during the period pre-specified in this trial
(7)
Is capable of understanding the trial, and complying with the requirements for the protocol, judged by the Investigator

(1)
Has poorly controlled and clinically significant disorder in neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, endocrine, hematological, immunological, dermatological or psychiatric system, or has a medical history of aforementioned them, which gives possibly impact to the study results
(2)
Has a history of recurrent or severe allergies to food, medicine, latex, etc, or a history of either anaphylactic reactions or serious intolerance against prescribed medicine, over-the-counter medicine or food
(3)
Has clinically significant abnormalities in vital signs, clinical laboratory tests or 12-lead ECG at screening test or a period prior to IP administration
(4)
Has disorder of clinical laboratory tests for hepatic function [alanine aminotransferase (ALT), aspartate aminotransferase (AST)] or renal function [urea nitrogen (BUN), serum creatinine], exceeding upper limit of normal range at screening test or prior to IP administration
(5)
Has a positive test result for hepatitis, HIV or syphilis at screening test
(6)
Has history of treatment with growth hormone
(7)
Has had acute disease associated with dehydration (e.g., nausea, vomiting, diarrhea) within 90 days prior to IP administration
(8)
Has used prescribed medicine, over-the-counter medicine or dietary supplement, which could affect safety or PK of IP within 10 days prior to IP administration
(9)
Has used any other investigational product or investigational medical device within 90 days prior to IP administration
(10)
Consumes 14 units or more of alcohol per week (one unit corresponds to 360 mL of beer, 100 mL of wine or 35 mL of spirits), or has history of alcoholism or drug/chemical abuse
(11)
Consumes 6 or more cups of caffeinated beverages (approx. 720 mg of caffeine) per day, such as coffee, tea, cola, energy drink or any other
(12)
Has had 400 mL or more of blood drawing (including blood donation) within 90 days prior to IP administration, or had 200 mL or more of blood drawing (including blood donation) within 30 days prior to IP administration, or donated blood component (plasma or platelet) within 14 days prior to IP administration
(13)
Has a positive urine test for drug abuse at screening test or prior to IP administration
(14)
Consumes smokes more than 10 cigarettes per day, or uses equivalent or more amount of the following nicotine-containing products: snuff tobacco, chewing tobacco, cigars, pipes, nicotine pads and nicotine substitutes
(15)
Has any condition that in the view of the Investigator, places the subject at high risk place of not completing the study
(16)
Is employed by the study site, or is a family member of such employee, or has a dependency relationship with such employee (e.g., spouse, parent, child, sibling), or may consent under duress
(17)
Is considered by the Investigator as an inadequate subject for this study due to any other reasons than above

Male

Healthy adult

investigational material(s)
Generic name etc : RBM-007
INN of investigational material : -
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigational material : single or two times subcutaneous administration, dose-escalating with sequential cohorts of 0.1 mg/kg, 0.3 mg/kg and 1.0 mg/kg. For the single-dose cohorts, each cohort is to be divided into two steps (one subject will receive the investigational product as the first step, then other three subjects will receive it as the next step).

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

safety
pharmacokinetics
Safety and tolerability:
treatment-emergent adverse events

Pharmacokinetics:
Cmax, Cmin, tmax, t1/2, AUC0-t, AUC0-inf, Vd/F, CL/F, MRT, etc

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+81-92-283-7701

May. 29, 2020