Increasing doses of DF5112 in healthy adults

A Phase 1 Double-Blind, Randomized, Placebo-Controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity and Pharmacodynamics of DF5112 in Healthy Adult Participants

This trial tests different single doses of DF5112 given by IV or subcutaneous injection to see if they are safe and to measure how the body handles the drug in healthy adults aged 18–55.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Dragonfly Therapeutics (Industry-sponsored)
• Locations: 1 site (Sydney, New South Wales)
• Trial ID: NCT07232121 on ClinicalTrials.gov

What this trial studies

This is a double-blind, randomized, placebo-controlled single-ascending-dose study in healthy adult volunteers. Up to 48 participants are planned across six cohorts (8 per cohort), with the possibility of additional intermediate dose cohorts. Participants receive DF5112 or placebo by IV or subcutaneous administration, remain in the clinic for about one week for observation, and return for follow-up visits through Day 29. The study will collect safety, tolerability, pharmacokinetic, pharmacodynamic, and immunogenicity data.

Who should consider this trial

Good fit: Healthy adults aged 18–55 with BMI 18.0–32.0 kg/m2, weight ≥45 kg, no significant medical history, and normal screening labs who can stay confined in the clinic for about one week and attend follow-ups.

Not a fit: People with active medical conditions, abnormal screening labs, BMI or weight outside the allowed range, or on medications affecting drug metabolism, and those seeking direct therapeutic benefit, are unlikely to receive clinical benefit from participation.

Why it matters

Potential benefit: If successful, the study could identify safe single-dose levels and early PK/PD information needed to advance DF5112 into patient studies.

How similar studies have performed: Single-ascending-dose, randomized, placebo-controlled Phase 1 studies are a standard first step that have guided development of many drugs, but DF5112 itself has no public efficacy data available yet.

Eligibility criteria

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.

Where this trial is running

Sydney, New South Wales

• Scientia Clinical Research Ltd — Sydney, New South Wales, Australia (Recruiting)

Study contacts

• Study coordinator: Christopher Argent

Conditions Healthy Participants; Healthy Adult Females; Healthy Adult Male; Healthy; Volunteer; Healthy Volunteer; Healthy Participant