New drug A-005 tested in healthy people for first time
NCT ID NCT07442149
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested the safety and how the body processes a new drug called A-005 in 135 healthy adults. Participants received either single or multiple doses of A-005 or a placebo. The goal was to check for side effects and measure drug levels in the blood and spinal fluid, not to treat any disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A-005
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
135 people
The number who actually took part.
- Started
-
Apr 2024
- Finished
-
Dec 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
19 to 55 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Healthy, adult, male or female 19-55 years of age, inclusive, at the screening visit. * Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit. * Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, and vital signs * No ECG findings of clinical significance * Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol. Exclusion Criteria: * History or evidence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or major surgery. * Current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications. * Creatinine phosphokinase levels \> ULN at the screening visit. * Clinically significant laboratory abnormalities in white blood cell count, absolute neutrophil count, or absolute lymphocyte count at the screening visit. * Triglyceride levels \> ULN at the screening visit. * Clinically significant abnormalities on urinalysis at the screening visit. * Any history of malignant disease excluding surgically resected skin squamous cell or basal cell carcinoma. * Presence of clinically relevant immunosuppression from immunodeficiency conditions such as common variable hypogammaglobulinemia. * Presence or evidence of recent sunburn, scar tissue, tattoo (more than 25% of body area), open sore, or branding that, in the opinion of the PI or designee, would interfere with interpretation of skin adverse reaction assessments, and, for Part C only, with the lumbar puncture. * Positive test results for active human immunodeficiency virus (HIV-1 and HIV-2), hepatitis B surface antigen (HBsAg), hepatitis B virus core antibody (HBcAb), or hepatitis C virus (HCV) antibodies at the screening visit. * Any positive responses within the past 12 months and in the opinion of the PI or designee on the C-SSRS at the screening visit or at first check-in (Day -1). * Presence or having sequelae of gastrointestinal, liver (including Gilbert's syndrome), kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs. Exception: cholecystectomy is allowed. * Use of any vaccinations, other than the COVID-19 vaccination, within 30 days prior to the first dosing. For the COVID-19 vaccination, the first or second vaccination must be received at least 15 days prior to the dosing. * Participation in another investigational clinical trial within 30 days (or 5 half-lives of the investigational agent) (whichever is longer) for small molecules and within 60 days for biologic compounds (or for the anticipated duration of the biologic compound's PD effects, whichever is longer), prior to the first dosing. * Any other condition or prior therapy that in the opinion of the PI or designee would make the subject unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements. * For Part C only: Subjects with bleeding disorders, relevant lab abnormalities (Screening international normalized ratio greater than 1.4, platelets less than 50), prior intolerance of lumbar puncture, anatomical reasons preventing safe or successful collection of fluid (skin infection at site of puncture, relevant spine surgery, spinal deformity, etc.), known intracranial space-occupying lesions with mass effect, posterior fossa masses, or relevant brain malformations (Arnold-Chiari malformation, etc.), exam findings suggestive of increased intracranial pressure, or known allergy/sensitivity to lidocaine or its derivatives will not be eligible.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Celerion
Lincoln, Nebraska, 68502, United States
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