Phase 1 Single Ascending Dose Study

NCT ID: NCT06934941

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-25
• Study Completion Date: 2026-03-30

Brief Summary

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.

Detailed Description

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

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

NM-101

NM-101 iv

Group Type: EXPERIMENTAL

NM-101

Intervention Type: DRUG

NM-101 IV versus placebo

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

NM-101

NM-101 IV versus placebo

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

Placebo

Eligibility Criteria

Inclusion Criteria

1. Male Healthy subjects, 18 to 60 years of age and in good health with no clinically significant abnormality identified on the medical history, physical examination or laboratory evaluation at screening

2. Body weight≥ 45kg and body mass index between 18 - 30 kg/m2

3. Normal blood pressure (systolic >90 and <140 mmHg, diastolic >40 and <90mmHg) and pulse rate 40-100bpm at screening visit. Blood pressure and pulse are measured after 3 minutes in supine position

4. Baseline QTc must be <450msec for men and <470msec for women

5. Normal 12-lead electrocardiogram at screening

6. No clinically significant abnormal laboratory test values at screening

7. No clinically significant findings on the clinical neurological and ophthalmic examinations at screening and at baseline

8. Good venous access in both arms

9. Willing to consent to participate in study prior to study specific screening procedures with the understanding that the subject has the right to withdraw from the study at any time without prejudice

10. Female subject who is surgically sterile, is postmenopausal, or agrees to use a highly effective method of birth control (2 methods strongly recommended) during the study and for 6 months after the dosing of NM-101.

Exclusion Criteria

1. History of serious adverse reaction or hypersensitivity to biological agents including immunoglobulins

2. Presence or history of any allergy requiring acute or chronic treatment; seasonal allergic rhinitis can be permitted unless the subject is taking systemic medication (nasal spray or local treatments permitted). Subjects having clinically significant drug or food allergies are also excluded.

3. History of autoimmune or inflammatory disease

4. Clinically significant (i.e., active) cardiovascular disease (e.g., hypertension, arrhythmia, myocardial infarction, heart failure, long QT syndrome or other conditions causing prolongation of the QT/QT interval corrected with Fridericia's formula [QTcF]) prior to screening.

5. History of cerebral vascular accident or stroke. Subjects having high risk of developing a stroke are also excluded.

6. History or positive test results at screening for human immunodeficiency virus (HIV), hepatitis B, hepatitis C

7. Positive in tuberculosis screening test (Quantiferon test)

8. Active infection within 4 weeks from screening and body temperature >38℃

9. Active immunization within 3 months prior to dosing of NM-101

10. History or clinically significant evidence of cardiovascular, endocrine (e.g. diabetes mellitus), respiratory, renal, hepatic, gastrointestinal, haematological neurologic, psychiatric or other disease

11. Chronic symptoms of pronounced constipation or diarrhoea or conditions associated with total or partial obstruction of the urinary track

12. History or presence of malignancy including solid tumors and hematologic malignancies except for basal cell and squamous cell carcinoma of the skin that had been completely excised and were considered cured with no evidence of disease ≥ 3 years

13. Participation in a clinical study during the previous 24 weeks i.e. from completion of the previous study to the planned first administration of the current study

14. Loss of >500mL blood including blood donation within 12 weeks prior to screening visit

15. Intake more than 24 units of alcohol per week (1 unit=250mL of beer, 100mL of wine or 35mL of spirits)

16. Smokers >5 cigarettes or the equivalent in tobacco daily. Must have been willing to abstain from using tobacco and tobacco-containing products for 72 hours prior to the dosing of NM-101 and during the inpatient monitoring period.

17. Treatment with any prescription medication and/or over-the-counter products (excluding acetaminophen, hormone replacement therapy (HRT) and birth control) within 30 days prior to dosing of NM-101. Routine vitamin therapy is allowed.

18. History of drug or alcohol abuse within the past 5 years, a positive urine drug test and/or a positive alcohol urine test at Screening visit

19. Surgery other than minor cosmetic surgery and minor dental surgery within 3 months from the screening visit

20. History of lumbar surgery for any reasons (e.g., herniated disc) or other contraindications to having al lumbar puncture (LP)

21. Vigorous physical exercise 48 hours prior to screening

22. Women with a positive pregnancy test at screening

23. Women who are breast feeding

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: collaborator

Neuramedy Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Seoul National University Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Facility Contacts

Seung Hwan Lee, MD, PhD

Role: primary

leejh413@snu.ac.kr

82-2-2072-1441

Other Identifiers

NM-101

Identifier Type: OTHER

Identifier Source: secondary_id

NM-101-01

Identifier Type: -

Identifier Source: org_study_id