Phase 1 Single Ascending Dose Study

Last updated: April 10, 2025
Sponsor: Neuramedy Co. Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Healthy Volunteers

Treatment

Placebo

NM-101

Clinical Study ID

NCT06934941
NM-101-01
NM-101
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male Healthy subjects, 18 to 60 years of age and in good health with no clinicallysignificant abnormality identified on the medical history, physical examination orlaboratory 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) andpulse 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 ophthalmicexaminations at screening and at baseline

  8. Good venous access in both arms

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

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

Exclusion

Exclusion Criteria:

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

  2. Presence or history of any allergy requiring acute or chronic treatment; seasonalallergic rhinitis can be permitted unless the subject is taking systemic medication (nasal spray or local treatments permitted). Subjects having clinically significantdrug 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 otherconditions causing prolongation of the QT/QT interval corrected with Fridericia'sformula [QTcF]) prior to screening.

  5. History of cerebral vascular accident or stroke. Subjects having high risk ofdeveloping 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, haematologicalneurologic, psychiatric or other disease

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

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

  13. Participation in a clinical study during the previous 24 weeks i.e. from completionof 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 screeningvisit

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

  16. Smokers >5 cigarettes or the equivalent in tobacco daily. Must have been willing toabstain from using tobacco and tobacco-containing products for 72 hours prior to thedosing 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 testand/or a positive alcohol urine test at Screening visit

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

  20. History of lumbar surgery for any reasons (e.g., herniated disc) or othercontraindications 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

Study Design

Total Participants: 36
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
November 25, 2024
Estimated Completion Date:
March 30, 2026

Study 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.

Connect with a study center

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

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