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Administration study of long-acting growth hormone preparations in healthy adults

Administration study of long-acting growth hormone preparations in healthy adults

12

In this study, healthy adults aged 20 to 35 years, 6 males with a BMI of 18.5 to 25.0 and 6 females with a BMI of 17.6 to 26.4 were selected as subjects.

Consent forms were obtained from 43 healthy adults, and 6 of them (3 males and 3 females) received 1.5 mg of Somapacitan (Product name: Sogroya® Subcutaneous Injection) and the other 6 subjects (3 males and 3 females) received 0.66 mg/kg of Somatrogon (Product name: Ngenla Inj. 60 mg Pens) on the second day of admission. All steps of the test including sampling were completed.

No adverse event was observed in the administration study.

Administration study of Long-Acting Growth Hormone Preparations was conducted with 12 healthy adult subjects. Sogroya Subcutaneous Injection (1.5 mg of Somapacitan) were administered to 6 subjects (3 males and 3 females) and Ngenla Inj. 60 mg Pens (0.66 mg/kg of Somatrogon) were administered to the other 6 subjects (3 males and 3 females). After the administration, all of the subject's urine were collected from the day before administration to 60 hours (discharge) and thereafter, their spot urine samples were collected at 96 hours. Blood samples were also collected from the subject's brachial median mesothelial vein and fingertip capillary at a total of 22 predetermined times according to the study plan. The biological samples were consequently obtained in order to evaluate the detection period of the unchanged drug and metabolites, the effect of different blood collection methods on detection, and the evaluation of analytical methods.

Administration study of Long-Acting Growth Hormone Preparations (Sogroya® Subcutaneous Injection and Ngenla Inj. 60 mg Pens) was conducted in which urine and blood samples were consequently collected from 12 healthy adult subjects in order to confirm the detection period of the unchanged drug and metabolites of Somapacitan and Somatrogon, the effect of different blood collection methods on detection, and to evaluate our analytical methods.

No

https://jrct.mhlw.go.jp/latest-detail/jRCT1001220001

Yonemura Takuma

Souseikai Sumida Hospital

Souseikai Sumida Hospital 1-29-1, Honjo, Sumida-ku, Tokyo 130-0004, Japan

takuma-yonemura@lta-med.com

Sato Mitsuhiko

LSI Medience Corporation

1-15-10 Shimura Itabashi-ku, Tokyo, Japan

+81-7055705211

satou.mitsuhiko@ma.medience.co.jp

Complete

Nov. 04, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

other

1) Men BMI18.5 or more but less than 25.0 at the time of prior examination.
2) Women: BMI 17.6 or more and less than 26.4 at the time of prior examination.
Person who is judged by Principal investigator or Sub-investigator that there is no problem with participation in the test.

1) Subjects who have had allergic symptoms due to drugs
2) Subjects who are being treated for some disease or who may receive treatment during the study period
3) Those who are suspected of suffering from or have a history of the following diseases
Test drug-1
benign intracranial hypertension, hypoadrenocorticism, diabetes, diabetic complications, brain tumor,
Heart disease, renal dysfunction, liver dysfunction
Test drug-2
malignant tumor, hypothyroidism, hypoadrenocorticism, diabetes, brain tumor, heart disease,
renal dysfunction
4) Subjects who are alcoholic or drug dependent, or have a history of depression.
5) Subjects who used ethical drugs or over-the-counter drugs within 2 weeks of the scheduled administration of the study drug
6)Subjects who took supplements, foods containing St. John's wort, grapefruit, or processed products thereof within 1 week of scheduled administration of the study drug
7) Subjects who received another investigational drug or investigational drug within 16 weeks of the scheduled administration date of the investigational drug, or an investigational drug or investigational drug containing an approved ingredient within 12 weeks
8) Subjects who received 200 mL or more of blood within 30 days of the scheduled administration of the study drug, 400 mL or more of blood within 90 days, and those who received component blood donation within 14 days of the scheduled administration of the study drug.
9) Subjects weighing less than 40kg and 90kg or more at the time of pre-examination
10) Those who are suspected of having a new coronavirus infection
11) Lactating women, pregnant women, and those who may become pregnant during the study period
12) Subjects who are judged inappropriate for participation in this study by the principal investigator or subinvestigator

Both

Healty adult subjects
Sample collection for evaluating analysis and sampling methods in antidoping

The candidate subject is hospitalized and biological samples (urine / blood) collection are started the next day. The study drug (Sogroya Subcutaneous(Somapacitan) or Njenla Inj.(Somatrogon) or is injected on the second day of hospitalization. The samples will be continuously collected from the subject based on the test protocol.

The evaluation on analysis method by examining the detectable period of the unchanged drug and the metabolite of the test drug

The confirmarion of the influence of the use of the test drug on biological marker variation

+81-922837701

Sept. 16, 2022

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