JRCT ID: jRCTs031250659
Registered date:20/01/2026
28-day Repeated-dose Study of SCO-240
Basic Information
| Recruitment status | Not Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Pediatric growth hormone deficiency |
| Date of first enrollment | 03/02/2026 |
| Target sample size | 18 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | Administer SCO-240 1 mg or 10 mg once daily for 28 days |
Outcome(s)
| Primary Outcome | Safety, Tolerability, and Pharmacodynamic |
|---|---|
| Secondary Outcome | NA |
Key inclusion & exclusion criteria
| Age minimum | >= 18age old |
|---|---|
| Age maximum | < 75age old |
| Gender | Male |
| Include criteria | - Gender: Male - At the time of informed consent, subjects in young adult group are aged >=18 and <65 and subject in older adult group are aged >=65 and <75. - Weight at screening: >=50 kg, body mass index (BMI) >=18.5 kg/m2 and =<25.0 kg/m2 |
| Exclude criteria | - Subjects who have a present illness such as cardiovascular disease, central nervous system disease, gastrointestinal disease, hematopoietic disease, renal failure, metabolic or endocrine disorder, serious allergy, asthma, hypoxemia, hypertension, convulsion or allergic rash. For older adult group, conditions with mild severity and no anticipated changes in medications are acceptable. |
Related Information
| Primary Sponsor | Watanabe Masanori |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Harunobu Nishizaki |
| Address | 26-1, Muraokahigashi 2-chome, Fujisawa, Kanagawa Kanagawa Japan 251-8555 |
| Telephone | +81-466-27-3205 |
| harunobu.nishizaki@scohia.com | |
| Affiliation | SCOHIA PHARMA, Inc. |
| Scientific contact | |
| Name | Masanori Watanabe |
| Address | 26-1, Muraokahigashi 2-chome, Fujisawa, Kanagawa Kanagawa Japan 251-8555 |
| Telephone | +81-466-27-3205 |
| info@scohia.com | |
| Affiliation | |