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Tests treatment safety and results for Healthy Participants
Official title A Study to Evaluate the Safety of Increasing Doses of DF5112 in Healthy Adults
ClinicalTrials.gov ID: NCT07232121
What this study is testing
What is DF5112?
DF5112 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for healthy participants.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a double-blind, randomized, placebo-controlled, single ascending dose (SAD) study to evaluate safety, tolerability, pharmacokinetics (PK), immunogenicity and pharmacodynamics (PD) of DF5112 in healthy adult participants. A total of 48 participants are planned to be randomized into 6 cohorts.
- Phase 1: an early, usually small safety study
- Time commitment: about 1 week
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the PI or...
You likely can't join if
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders...
- History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5...
- History of or evidence of recurrent or chronic bacterial or fungal infections including those of the skin, vagina, oral cavity, etc., or systemic...
- 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.
See the full eligibility 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...
- Clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the PI or designee. Key
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Sydney, New South Wales, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 week per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sydney, New South Wales, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.