Healthy SubjectsPhase 1NCT06934941
Phase 1 Single Ascending Dose Study
A Phase 1 study testing NM-101 in people with Healthy Subjects, run by Neuramedy Co. Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- NM-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Nov 2024to 30 Mar 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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
Show all 23Show fewer
- 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)
- 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.
- 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.
- 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
- Surgery other than minor cosmetic surgery and minor dental surgery within 3 months from the screening visit
- History of lumbar surgery for any reasons (e.g., herniated disc) or other contraindications to having al lumbar puncture (LP)
- Vigorous physical exercise 48 hours prior to screening
- Women with a positive pregnancy test at screening
- Women who are breast feeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Seung Hwan Lee, MD, PhD, 82-2-2072-1441, leejh413@snu.ac.kr
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of NM-101
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.
Read the 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
- Being tested
- NM-101, Placebo
- Keywords
- Single Ascending Dose study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NM-101Drug
Also called Placebo
NM-101 IV versus placebo
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| NM-101 | Experimental | NM-101 iv Receives: Drug: NM-101 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the pharmacokinetic profile of NM-101 after a single iv infusion
Peak plasma drug concentration (Cmax)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start25 Nov 2024
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuramedy Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Seoul National University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934941
- Sponsor's protocol ID
- NM-101-01
- Other IDs
- NM-101
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of NM-101
- ClinicalTrials.gov ID
- NCT06934941
- Acronym / sponsor ID
- NM-101-01
- Conditions
- Healthy Subjects
- Keywords
- Single Ascending Dose study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Neuramedy Co. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Seoul National University Hospital
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NM-101 | Experimental | Drug: NM-101NM-101 iv |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NM-101Also: PlaceboNM-101 IV versus placebo | Drug | NM-101 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
To determine the pharmacokinetic profile of NM-101 after a single iv infusion
Time frame: 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
Peak plasma drug concentration (Cmax)
To determine the pharmacokinetic profile of NM-101 after a single iv infusion
Time frame: 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
Area under the plasma concentration versus time curve (AUC) at steady-state and until last observation
To determine the pharmacokinetic profile of NM-101 after a single iv infusion
Time frame: 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
Concentration at trough
To determine the pharmacokinetic profile of NM-101 after a single iv infusion
Time frame: 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
Time to maximum drug concentration
To determine the pharmacokinetic profile of NM-101 after a single iv infusion
Time frame: 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
half-life of drug
To determine the pharmacokinetic profile of NM-101 after a single iv infusion
Time frame: 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
Volume distribution of drug
To determine the pharmacokinetic profile of NM-101 after a single iv infusion
Time frame: 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
Clearance rate of drug
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Healthy Subjects
Not yet recruitingPhase 1
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
Healthy Participants
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
Active, not recruitingPhase 1
A Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283
Asthma
RecruitingPhase 4
Testing Healthy Participants for Drowsiness After Single Dosing of Two Different Doses of Muscle Relaxer
Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NM-101 in people with Healthy Subjects, run by Neuramedy Co. Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the pharmacokinetic profile of NM-101 after a single iv infusion (time frame: 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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.