Actively Recruiting
Phase 1 Single Ascending Dose Study
Led by Neuramedy Co. Ltd. · Updated on 2025-04-18
36
Participants Needed
1
Research Sites
70 weeks
Total Duration
On this page
Sponsors
N
Neuramedy Co. Ltd.
Lead Sponsor
S
Seoul National University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Phase 1, double-blind, placebo-controlled, single-centre, single ascending dose escalation study to assess safety and tolerability of a monoclonal antibody, NM-101 in healthy volunteer subject and multiple system atrophy (MSA) patients.
CONDITIONS
Official Title
Phase 1 Single Ascending Dose Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male healthy subjects aged 18 to 60 years in good health with no significant abnormalities on medical history, physical exam, or lab tests
- Body weight 45 kg or more and body mass index between 18 and 30 kg/m2
- Normal blood pressure (systolic >90 and <140 mmHg, diastolic >40 and <90 mmHg) and pulse rate between 40 and 100 bpm at screening
- Baseline QTc less than 450 msec for men and less than 470 msec for women
- Normal 12-lead electrocardiogram at screening
- No clinically significant abnormal laboratory test values at screening
- No significant findings on neurological and ophthalmic exams at screening and baseline
- Good venous access in both arms
- Willingness to provide informed consent and understanding of the right to withdraw at any time
- Female subjects must be surgically sterile, postmenopausal, or agree to use highly effective birth control (two methods strongly recommended) during the study and for 6 months after dosing
You will not qualify if you...
- History of serious adverse reactions or hypersensitivity to biological agents including immunoglobulins
- Presence or history of allergies requiring acute or chronic treatment; seasonal allergic rhinitis allowed if no systemic medication used
- History of autoimmune or inflammatory disease
- Active cardiovascular disease including hypertension, arrhythmia, myocardial infarction, heart failure, long QT syndrome, or other QT prolonging conditions
- History of stroke or cerebral vascular accident or high risk for stroke
- Positive tests for HIV, hepatitis B, or hepatitis C
- Positive tuberculosis screening test
- Active infection within 4 weeks before screening with body temperature over 38°C
- Active immunization within 3 months prior to dosing
- History or evidence of significant cardiovascular, endocrine, respiratory, renal, hepatic, gastrointestinal, hematologic, neurologic, psychiatric or other diseases
- Chronic constipation or diarrhea or urinary tract obstruction
- History or presence of malignancy except cured basal or squamous cell skin cancer for at least 3 years
- Participation in another clinical study within 24 weeks prior to dosing
- Blood loss over 500 mL or blood donation within 12 weeks prior to screening
- Alcohol intake exceeding 24 units per week
- Smoking more than 5 cigarettes or equivalent tobacco daily; must abstain 72 hours before dosing and during inpatient monitoring
- Use of prescription or over-the-counter medications (excluding acetaminophen, HRT, or birth control) within 30 days prior to dosing
- History of drug or alcohol abuse within 5 years or positive urine drug/alcohol test at screening
- Surgery other than minor cosmetic or dental surgery within 3 months prior to screening
- History of lumbar surgery or contraindication to lumbar puncture
- Vigorous physical exercise within 48 hours prior to screening
- Positive pregnancy test or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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