Phase 1 Single Ascending Dose Study

NCT06934941 | Recruiting Phase 1

• 2 other identifiers: NM-101-01NM-101
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Keywords

Single Ascending Dose study

Outcome Measures

Primary Outcomes (7)

• To determine the pharmacokinetic profile of NM-101 after a single iv infusion

  Peak plasma drug concentration (Cmax)

  Pre-dose, 0, 0.5, 1, 2, 4, 6, 8, 12hour post-dose at Day 1 and Day 2, 3, 4, 8, 15, 22, 29 and week 6, 8, 12

• To determine the pharmacokinetic profile of NM-101 after a single iv infusion

  Area under the plasma concentration versus time curve (AUC) at steady-state and until last observation

  Pre-dose, 0, 0.5, 1, 2, 4, 6, 8, 12hour post-dose at Day 1 and Day 2, 3, 4, 8, 15, 22, 29 and week 6, 8, 12

• To determine the pharmacokinetic profile of NM-101 after a single iv infusion

  Concentration at trough

  Pre-dose, 0, 0.5, 1, 2, 4, 6, 8, 12hour post-dose at Day 1 and Day 2, 3, 4, 8, 15, 22, 29 and week 6, 8, 12

• To determine the pharmacokinetic profile of NM-101 after a single iv infusion

  Time to maximum drug concentration

  Pre-dose, 0, 0.5, 1, 2, 4, 6, 8, 12hour post-dose at Day 1 and Day 2, 3, 4, 8, 15, 22, 29 and week 6, 8, 12

• To determine the pharmacokinetic profile of NM-101 after a single iv infusion

  half-life of drug

  Pre-dose, 0, 0.5, 1, 2, 4, 6, 8, 12hour post-dose at Day 1 and Day 2, 3, 4, 8, 15, 22, 29 and week 6, 8, 12

• To determine the pharmacokinetic profile of NM-101 after a single iv infusion

  Volume distribution of drug

  Pre-dose, 0, 0.5, 1, 2, 4, 6, 8, 12hour post-dose at Day 1 and Day 2, 3, 4, 8, 15, 22, 29 and week 6, 8, 12

• To determine the pharmacokinetic profile of NM-101 after a single iv infusion

  Clearance rate of drug

  Pre-dose, 0, 0.5, 1, 2, 4, 6, 8, 12hour post-dose at Day 1 and Day 2, 3, 4, 8, 15, 22, 29 and week 6, 8, 12

Study Arms (2)

NM-101

EXPERIMENTAL

NM-101 iv

Drug: NM-101

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

NM-101 DRUG

NM-101 IV versus placebo

Also known as: Placebo

NM-101

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Body weight≥ 45kg and body mass index between 18 - 30 kg/m2
• 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
• Baseline QTc must be \<450msec for men and \<470msec for women
• Normal 12-lead electrocardiogram at screening
• No clinically significant abnormal laboratory test values at screening
• No clinically significant findings on the clinical neurological and ophthalmic examinations at screening and at baseline
• Good venous access in both arms
• 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
• 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.

You may not qualify if:

• History of serious adverse reaction or hypersensitivity to biological agents including immunoglobulins
• 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.
• History of autoimmune or inflammatory disease
• 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.
• History of cerebral vascular accident or stroke. Subjects having high risk of developing a stroke are also excluded.
• History or positive test results at screening for human immunodeficiency virus (HIV), hepatitis B, hepatitis C
• Positive in tuberculosis screening test (Quantiferon test)
• Active infection within 4 weeks from screening and body temperature \>38℃
• Active immunization within 3 months prior to dosing of NM-101
• History or clinically significant evidence of cardiovascular, endocrine (e.g. diabetes mellitus), respiratory, renal, hepatic, gastrointestinal, haematological neurologic, psychiatric or other disease
• Chronic symptoms of pronounced constipation or diarrhoea or conditions associated with total or partial obstruction of the urinary track
• 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
• 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
• Loss of \>500mL blood including blood donation within 12 weeks prior to screening visit
• Intake more than 24 units of alcohol per week (1 unit=250mL of beer, 100mL of wine or 35mL of spirits)

Sponsors & Collaborators

• Neuramedy Co. Ltd.: lead
• Seoul National University Hospital: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 18, 2025
• Study Start: November 25, 2024
• Primary Completion: October 30, 2025
• Study Completion: March 30, 2026
• Last Updated: April 18, 2025

Record last verified: 2025-04

Locations

KR (1)