New drug DF5112 put to the test in healthy volunteers
NCT ID NCT07232121
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests a new drug, DF5112, in 48 healthy adults to see if it is safe and how the body handles it. Participants receive a single dose of the drug or a placebo and are monitored for about a week in a clinic, with follow-up visits for a month. The goal is to gather information on side effects, drug levels in the blood, and immune reactions.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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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.
Key Inclusion Criteria: * Male or female participants aged 18 to 55 years (inclusive) at the time of informed consent. * Body mass index (BMI) between ≥ 18.0 and ≤ 32.0 kg/m2 and body weight ≥ 45 kg. * At the discretion of the Principal Investigator (PI) or designee, in good general health, with no significant medical history, and have no clinically significant abnormalities on physical examination at Screening and/or before the first administration of IP. * Clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the PI or designee. Key Exclusion Criteria: * History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders that, in the opinion of the PI or designee, are capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data. * History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases (except for squamous and basal cell carcinoma of the skin or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed). * History of or evidence of recurrent or chronic bacterial or fungal infections including those of the skin, vagina, oral cavity, etc., or systemic fungal infection. * History of unexplained, recurrent infection, or infection requiring treatment with systemic antibiotics within 90 days prior to dosing on Day 1. * Active oral infection. * Acute illness (e.g. common cold) within 2 weeks prior to Screening, or seasonal influenza or COVID within 4 weeks prior to Screening. * History of latent or active tuberculosis that has not been adequately treated, at the discretion of the PI or designee. * Positive or inconclusive hepatitis B or hepatitis C based antibody tests at Screening. * Positive human immunodeficiency virus (HIV) antibody test at Screening. * History of severe allergy, hypersensitivity reaction, or anaphylaxis to drugs or human proteins or components of the study drug formulation used in this study. * Any vaccination within 1 month of Day 1 and planned within 1 month post Day 1. Any live or attenuated vaccine within 1 month prior to Day 1 and planned within 3 months post Day 1.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Scientia Clinical Research Ltd
RECRUITINGSydney, New South Wales, 2031, Australia
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