Healthy VolunteersPhase 1NCT07422207
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ME3241 Administered Intravenously in Healthy Adult Participants
A Phase 1 study testing ME3241 in people with Healthy Volunteers, run by Meiji Pharma USA Inc. at 1 site in Australia.
Trial summary
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ME3241 Administered Intravenously in Healthy Adult Participants Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ME3241
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteAustralia
- Study dates
- 23 Mar 2026to Jul 2027
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent.
- Participant must be in good general health as determined by the investigator based on medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests.
- Participant must have body weight > 45 kg at the Screening Visit.
- Participant must have a body mass index (BMI) between 18.0 and 30.0 kg/m^2 at the Screening Visit. BMI = body weight (kg)/(height [m])^2.
Who cannot join
- Participant with concurrent or history of potentially fatal infections such as opportunistic infections, including sepsis and systemic fungal infection.
- Participant with history of pulmonary infiltrates or pneumonia within 6 months prior to the Screening Visit.
- Participant with concurrent or history of autoimmune, cardiac, hepatic, renal, gastrointestinal, respiratory, endocrine, neurological, central nervous, mental disorders, and/or hematological function disorders, which, in the judgment of the investigator, may affect participation in this clinical study.
- Participant with history and/or presence of malignancy of any organ system (including basal cell carcinoma of the skin), treated or untreated.
- Other protocol defined inclusion/exclusion criteria could apply.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Scientia Clinical Reserch Ltd
Sydney, New South Wales, 2031
Dr Christopher Argent, +61 2 9382 5800, christopher.argent@scientiaclinicalresearch.com.au
About this study
Official title: A Phase 1, First-in-Human, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ME3241 Administered Intravenously in Healthy Adult Participants
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ME3241 Administered Intravenously in Healthy Adult Participants
- Conditions
- Healthy Volunteers
- Being tested
- ME3241, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ME3241Biological
Part 1 (single ascending dose):
Participants will receive a single infusion of ME3241.
Part 2 (multiple ascending dose):
Participants will receive multiple infusions of ME3241.
Part 3 (single dose for Japanese participants):
Japanese participants will receive a single infusion of ME3241.
PlaceboOther
Part 1 (single ascending dose):
Participants will receive a single infusion of placebo.
Part 2 (multiple ascending dose):
Participants will receive multiple infusions of placebo.
Part 3 (single dose for Japanese participants):
Japanese participants will receive a single infusion of placebo.
| Study group | Role | What they receive |
|---|---|---|
| ME3241 | Experimental | Not described Receives: Biological: ME3241 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of AEs and SAEs
Evaluation of the number and percentage of participants with AEs, treatment-emergent adverse events (TEAEs), and the number of TEAEs
Measured: From baseline to 12 weeks after the last administration
Changes in vital signs
Evaluation of body temperature, blood pressure, and pulse
Measured: From baseline to 12 weeks after the last administration
Changes in physical examinations
Evaluation of the number and percentage of participants with normal/non-clinically significant abnormal or clinically significant abnormal results in physical examination
Measured: From baseline to 12 weeks after the last administration
Changes in 12-lead ECGs
Evaluation of PR, QRSd, and QT/QTcF intervals
Measured: From baseline to 12 weeks after the last administration
Changes in laboratory parameters
Evaluation of Hematology, Clinical chemistry, Coagulation, and Urinalysis parameters
Measured: From baseline to 12 weeks after the last administration
Maximum observed serum concentration (Cmax)
Evaluation of the maximum observed serum concentration of ME3241
Measured: From baseline to 12 weeks after the last administration
Area under the curve from time zero to the last quantifiable concentration (AUClast)
Evaluation of the area under the curve from time zero to the last quantifiable concentration
Measured: From baseline to 12 weeks after the last administration
Area under the curve from time zero extrapolated to infinity (AUC0-∞)
Evaluation of the area under the curve from time zero extrapolated to infinity
Measured: From baseline to 12 weeks after the last administration
Area under the curve over the dosing interval after multiple dose administration (AUCtau)
Evaluation of the area under the curve over the dosing interval after multiple dose administration
Measured: From baseline to 12 weeks after the last administration
Apparent terminal elimination half-life (t1/2)
Evaluation of the apparent terminal elimination half-life
Measured: From baseline to 12 weeks after the last administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start23 Mar 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meiji Pharma USA Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422207
- Sponsor's protocol ID
- ME3241-1
- Status last verified
- Mar 2026
- First submitted
- 4 Feb 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-Human, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ME3241 Administered Intravenously in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07422207
- Acronym / sponsor ID
- ME3241-1
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Meiji Pharma USA Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 19 Feb 2026 (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.
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ME3241 Administered Intravenously in Healthy Adult Participants
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ME3241 | Experimental | Biological: ME3241 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent.
- Participant must be in good general health as determined by the investigator based on medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests.
- Participant must have body weight > 45 kg at the Screening Visit.
- Participant must have a body mass index (BMI) between 18.0 and 30.0 kg/m^2 at the Screening Visit. BMI = body weight (kg)/(height [m])^2.
Key exclusion criteria (5 listed)
- Participant with concurrent or history of potentially fatal infections such as opportunistic infections, including sepsis and systemic fungal infection.
- Participant with history of pulmonary infiltrates or pneumonia within 6 months prior to the Screening Visit.
- Participant with concurrent or history of autoimmune, cardiac, hepatic, renal, gastrointestinal, respiratory, endocrine, neurological, central nervous, mental disorders, and/or hematological function disorders, which, in the judgment of the investigator, may affect participation in this clinical study.
- Participant with history and/or presence of malignancy of any organ system (including basal cell carcinoma of the skin), treated or untreated.
- Other protocol defined inclusion/exclusion criteria could apply.
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 |
|---|---|---|
| ME3241Part 1 (single ascending dose): Participants will receive a single infusion of ME3241. Part 2 (multiple ascending dose): Participants will receive multiple infusions of ME3241. Part 3 (single dose for Japanese participants): Japanese participants will receive a single infusion of ME3241. | Biological | ME3241 |
| PlaceboPart 1 (single ascending dose): Participants will receive a single infusion of placebo. Part 2 (multiple ascending dose): Participants will receive multiple infusions of placebo. Part 3 (single dose for Japanese participants): Japanese participants will receive a single infusion of placebo. | Other | Placebo |
Primary outcome
Incidence and severity of AEs and SAEs
Time frame: From baseline to 12 weeks after the last administration
Evaluation of the number and percentage of participants with AEs, treatment-emergent adverse events (TEAEs), and the number of TEAEs
Changes in vital signs
Time frame: From baseline to 12 weeks after the last administration
Evaluation of body temperature, blood pressure, and pulse
Changes in physical examinations
Time frame: From baseline to 12 weeks after the last administration
Evaluation of the number and percentage of participants with normal/non-clinically significant abnormal or clinically significant abnormal results in physical examination
Changes in 12-lead ECGs
Time frame: From baseline to 12 weeks after the last administration
Evaluation of PR, QRSd, and QT/QTcF intervals
Changes in laboratory parameters
Time frame: From baseline to 12 weeks after the last administration
Evaluation of Hematology, Clinical chemistry, Coagulation, and Urinalysis parameters
Maximum observed serum concentration (Cmax)
Time frame: From baseline to 12 weeks after the last administration
Evaluation of the maximum observed serum concentration of ME3241
Area under the curve from time zero to the last quantifiable concentration (AUClast)
Time frame: From baseline to 12 weeks after the last administration
Evaluation of the area under the curve from time zero to the last quantifiable concentration
Area under the curve from time zero extrapolated to infinity (AUC0-∞)
Time frame: From baseline to 12 weeks after the last administration
Evaluation of the area under the curve from time zero extrapolated to infinity
Area under the curve over the dosing interval after multiple dose administration (AUCtau)
Time frame: From baseline to 12 weeks after the last administration
Evaluation of the area under the curve over the dosing interval after multiple dose administration
Apparent terminal elimination half-life (t1/2)
Time frame: From baseline to 12 weeks after the last administration
Evaluation of the apparent terminal elimination half-life
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 6 Apr 2026.
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Screening Protocol
Pain
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 ME3241 in people with Healthy Volunteers, run by Meiji Pharma USA Inc. at 1 site in Australia.
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 4 inclusion and 5 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 6 Apr 2026. 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 Australia. 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?
Contact Meiji Pharma USA Inc. Study Lead (+1 201-777-7133, mpu.clinical@meiji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of AEs and SAEs (time frame: From baseline to 12 weeks after the last administration). The study lists 10 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 6 Apr 2026.