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Recruiting NCT07422207

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ME3241 Administered Intravenously in Healthy Adult Participants

Phase I Interventional Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ME3241, Placebo.
Who it may be relevant to
Registry conditions: Healthy Volunteers. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ME3241 Administered Intravenously in Healthy Adult Participants

Interventions

  • Biological ME3241
    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.
  • Other Placebo
    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.

Primary outcome measures

  • Incidence and severity of AEs and SAEs [Time frame: From baseline to 12 weeks after the last administration]
  • Changes in vital signs [Time frame: From baseline to 12 weeks after the last administration]
  • Changes in physical examinations [Time frame: From baseline to 12 weeks after the last administration]
  • Changes in 12-lead ECGs [Time frame: From baseline to 12 weeks after the last administration]
  • Changes in laboratory parameters [Time frame: From baseline to 12 weeks after the last administration]
  • Maximum observed serum concentration (Cmax) [Time frame: From baseline to 12 weeks after the last administration]
  • Area under the curve from time zero to the last quantifiable concentration (AUClast) [Time frame: From baseline to 12 weeks after the last administration]
  • Area under the curve from time zero extrapolated to infinity (AUC0-∞) [Time frame: From baseline to 12 weeks after the last administration]
  • Area under the curve over the dosing interval after multiple dose administration (AUCtau) [Time frame: From baseline to 12 weeks after the last administration]
  • Apparent terminal elimination half-life (t1/2) [Time frame: From baseline to 12 weeks after the last administration]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Quadruple blind
Primary purpose
Basic science

Study locations

Australia · 1 center
  • Scientia Clinical Reserch Ltd — Sydney

Identifiers

NCT: NCT07422207 · ME3241-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗