Phase I SCO-240 single dose study

A Randomized, Single-Center, Double-Blind, Placebo-Controlled, Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of SCO-240 in Healthy Adult Subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2051210027

Enrollment

Registered

2021-05-19

Start date

2021-05-23

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholelithiasis

Interventions

[Dose Ascending Part] Single oral dose of SCO-240 1mg, 3mg, 20mg, 40mg, 80mg, 160mg or placebo with fasted condition [Racial Difference Effect Part] Single oral dose of SCO-240 20mg or placebo with

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Gender: Male - Race: Healthy Japanese adults: The subject's parents and grand parents are Japanese Healthy Caucasian adults: The subject's parents and grandparents are Caucasian - Age: Subjects are between 20 and 45 years, inclusive, at the time of informed consent - Weight at screening: Healthy Japanese adults: >=50 kg, body mass index (BMI) >=18.5 kg/m2 and ==50 kg, BMI >=18.5 kg/m2 and =<30.0 kg/m2

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
-Safety, pharmacokinetics and pharmacodynamics	—

Contacts

Public ContactClinical Development Division

SCOHIA PHARMA, Inc.

info@scohia.com+81-466-322-1592

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026