Healthy ParticipantsPhase 1DF5112NCT07232121
A Study to Evaluate the Safety of Increasing Doses of DF5112 in Healthy Adults
A Phase 1 study testing DF5112 in people with Healthy Participants and Healthy Adult Females, run by Dragonfly Therapeutics at 1 site in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Healthy Adult Females, Healthy Adult Male
- What is being tested?
- DF5112
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteAustralia
- Study dates
- 12 Jan 2026to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Scientia Clinical Research Ltd
Sydney, New South Wales, 2031
Christopher Argent
About this study
Official title: 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 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. Additional cohorts at intermediate dose levels may be evaluated. Each cohort will include 8 healthy participants randomized to receive DF5112 or placebo through intravenous (IV) or subcutaneous (SC) administration. Following dose administration participants will be confined at the clinical research unit for observation for approximately 1 week and then will return for subsequent pre-identified follow up visits through Day 29.
- Being tested
- DF5112, Placebo
- Keywords
- Healthy Volunteer, Healthy Participant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DF5112Drug
DF5112 administered IV or SC
PlaceboOther
Placebo administered IV or SC.
| Study group | Role | What they receive |
|---|---|---|
| DF5112 | Experimental | Single dose of DF5112 administered either via IV or SC Receives: Drug: DF5112 |
| Placebo | Placebo comparator | Single dose of placebo administered either via IV or SC Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Treatment Emergent Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: From Day 1 dosing to end of study at Day 29
Secondary outcomes (2)
To evaluate the PK of single ascending doses of DF5112 administered by IV or SC injection
PK parameter: Area Under the Concentration Curve (AUC)
Measured: From Day 1 dosing to end of study at Day 29
Incidence and titer of Anti-Drug Antibodies
Measured: From Day 1 dosing to end of study at Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start12 Jan 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dragonfly Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232121
- Sponsor's protocol ID
- DF5112-001
- Acronym
- DF5112
- Status last verified
- Mar 2026
- First submitted
- 13 Nov 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07232121
- Acronym / sponsor ID
- DF5112 / DF5112-001
- Keywords
- Healthy Volunteer, Healthy Participant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Dragonfly TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Additional cohorts at intermediate dose levels may be evaluated. Each cohort will include 8 healthy participants randomized to receive DF5112 or placebo through intravenous (IV) or subcutaneous (SC) administration. Following dose administration participants will be confined at the clinical research unit for observation for approximately 1 week and then will return for subsequent pre-identified follow up visits through Day 29.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DF5112 | Experimental | Drug: DF5112Single dose of DF5112 administered either via IV or SC |
| Placebo | Placebo comparator | Other: PlaceboSingle dose of placebo administered either via IV or SC |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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 (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DF5112DF5112 administered IV or SC | Drug | DF5112 |
| PlaceboPlacebo administered IV or SC. | Other | Placebo |
Primary outcome
Number of participants with Treatment Emergent Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: From Day 1 dosing to end of study at Day 29
2 secondary outcomes
To evaluate the PK of single ascending doses of DF5112 administered by IV or SC injection
Time frame: From Day 1 dosing to end of study at Day 29
Incidence and titer of Anti-Drug Antibodies
Time frame: From Day 1 dosing to end of study at Day 29
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DF5112 in people with Healthy Participants and Healthy Adult Females, run by Dragonfly Therapeutics at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Argent (+61 2 9382 5844, christopher.argent@scientiaclinicalresearch.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Treatment Emergent Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (time frame: From Day 1 dosing to end of study at Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.