A PHASE I, TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND IMMUNOGENICITY OF RAY121 IN HEALTHY VOLUNTEERS

A PHASE I, RANDOMIZED, DOUBLE-BLIND ,PLACEBO-CONTROLLED, DOSE ASCENDING, SINGLE DOSE STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND IMMUNOGENICITY OF RAY121 IN HEALTHY VOLUNTEERS

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071220036

Enrollment

Registered

2022-08-04

Start date

2022-10-24

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

Healthy Volunteer

Interventions

RAY121: RAY121 is administered as a intravenously or subcutaneously at the prescribed dose.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Signed ICF - Able to comply with the study protocol, in the investigators judgment - BMI at screening: (Body weight [kg]/height [m]2) =>18.5 to <25.0 - Absence of evidence of any active or chronic disease following a detailed medical and surgical history and complete physical examination, vital signs, 12-lead ECG, and laboratory tests

Exclusion criteria

Exclusion criteria: - Clinically significant ECG abnormalities at screening - known congenital arrhythmiarespiratory, circulatory, endocrine, hematological, gastrointestinal, immune, psychological/nervous system, renal, hepatic, or allergic disorder

Design outcomes

Primary

Measure	Time frame
Safety Frequency, severity and causal reletionship of AE and SAE with RAY121 Changes in Lab value,Vital, and ECG parameters from Baseline	—

Secondary

Measure	Time frame
Phamacokinetics, Phamacodynamics	—

Contacts

Public ContactClinical trials information

Chugai Pharmaceutical Co., Ltd.

clinical-trials@chugai-pharm.co.jp+81-120-189-706

Outcome results

None listed

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