Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Can a prefilled pen match a syringe for this biosimilar?

NCT ID NCT07744828

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time

Summary

This study compares two ways of giving the same experimental biosimilar drug, DRL_AB, which is designed to work like abatacept for autoimmune conditions. Healthy male volunteers receive a single dose either through an autoinjector or a prefilled syringe. Researchers measure how much drug reaches the blood and how the body handles it, to see if both devices deliver the medicine equally well and safely.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
DRL_AB, a proposed biosimilar of abatacept, given as a subcutaneous injection
What this could lead to
If the two injection methods deliver the drug similarly, it could support a more convenient autoinjector option for patients who need abatacept.
What could go wrong
This is an early-stage study in healthy volunteers, not patients, so results may not predict real-world effectiveness. Injection-site reactions or other side effects are possible.

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

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

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

18 to 50 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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: 1. Healthy male volunteers aged 18 to 50 years (both inclusive) at the time of signing informed consent form. 2. Ability and amenability to provide written informed consent to participate in the study and adhere to study requirements. 3. Body mass index in the range 18.5-30.0 kilogram per meter square (kg/m\^2) (both inclusive) and body weight of 60.0-100.0 kilogram (kg) (both inclusive). 4. General good health as determined by a qualified physician based on a comprehensive medical history, physical examination, vital signs, clinical laboratory tests (hematology, biochemistry, and urinalysis), and 12-lead electrocardiogram (ECG) during screening. 5. Vital signs, physical examination, clinical laboratory tests, and 12-lead ECG results within normal range, or if outside the normal range, then assessed as clinically non-significant by the investigator (unless the value constitutes an explicit exclusion criterion). 6. Willingness to use or with female partners (women of childbearing potential \[WOCBP\]) willing to use at least one highly effective method of contraception as described below up to at least 3 months from the time of study intervention administration. Note: Highly effective birth control measures per Clinical Trials Facilitation and Coordination Group (CTCG) guidelines 202414 include the following: For a male participant: * Permanently sterile by bilateral orchidectomy * Vasectomy * Maintaining sexual abstinence\*. For the female partner of a male participant: * Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation - oral, intravaginal, injectable, and transdermal. * Progestogen-only hormonal contraception associated with inhibition of ovulation - oral, injectable, and implantable. * Intrauterine device * Intrauterine hormone-releasing system * Bilateral tubal occlusion Sexual abstinence defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. \[Note: The reliability of sexual abstinence needs to be evaluated as per investigator's judgement in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. It should be considered as true abstinence only; and not periodic abstinence (such as calendar, symptothermal, post-ovulation methods)\]. 7. Willingness to abide by study restrictions for the entire study duration. Exclusion Criteria: 1. Positive or 2 successive indeterminate test results for Quantiferon-tuberculosis (TB) Gold test. 2. Positive results for syphilis, hepatitis B (HBsAg, HBsAb, HBcAb), hepatitis C, or human immunodeficiency virus (HIV)-1 or 2. 3. Any prior exposure to abatacept or any other agent directly acting on CTLA4 or the CD28-CD80 co-stimulation pathway \[e.g., pembrolizumab, ipilimumab, nivolumab, and atezolizumab\] including investigational products. 4. Vaccination with live vaccines within 3 months prior to screening or intention to receive live vaccines during the trial or up to 3 months after the administration of the study intervention. Participants who have been administered non-live vaccines at least more than a week prior to study intervention administration may be included. 5. History of immunodeficiency or other clinically significant immunological disorders, autoimmune disorders, or ongoing or frequent/recurring infections defined as \>3 infections per year requiring treatment, participants with prior herpes zoster infection not fully healed (including the post-herpetic neuralgia period if present) within one year prior to randomization, or participants with history of systemic fungal infection within the 6 months prior to screening. 6. Allergy or hypersensitivity to any recombinant human or humanized antibodies, other therapeutic proteins or any excipients (dibasic sodium phosphate anhydrous, monobasic sodium phosphate monohydrate, L-histidine, sodium chloride, poloxamer and sucrose) of the study interventions. 7. History and/or current manifestations of clinically significant (in the opinion of the investigator) atopic allergy (e.g., asthma including childhood asthma currently showing clinical manifestations, urticaria, angioedema, eczematous dermatitis), hypersensitivity, or allergic reactions or any history or presence of vasculitis or psoriasis. 8. Skin not suitable for dosing or post-dosing evaluations on the upper arm for any reasons (including presence of tattoos, skin pigmentation disorders, scarring etc., which may obscure the injection site). 9. Participation in blood donation or in any study requiring repeated blood sampling, hemorrhage requiring treatment, any transfusion in the past 3 months, or plasma donation within the 14 days prior to screening. 10. Systolic blood pressure \>140 millimeter of mercury (mm Hg) or diastolic blood pressure \>90 mm Hg when measured in the sitting position after 5 minutes rest, or current use of antihypertensive drugs. Participants may be enrolled if blood pressure measurement is repeated up to 2 times on same or different days and if the mean of the measurements is within the above limits. 11. History of relevant orthostatic hypotension, fainting spells, or blackouts as well as history of difficulties with blood sampling that may potentially interfere with the study objectives and be deemed in the opinion of the investigator to pose clinical risk to the participants. 12. QTc (Fridericia correction) longer than 450 milliseconds or other clinically relevant ECG abnormalities such as atrial fibrillation, atrial flutter, Wolf-Parkinson-White syndrome, or presence of a cardiac pacemaker as found relevant clinically by the investigator. 13. History or presence of any clinically relevant nervous system disease including, but not restricted to stroke, transient ischemic attack, or seizures other than febrile seizures before the age of 5 years. 14. History of and/or current gastrointestinal, renal, endocrine, pulmonary, hepatic, cardiovascular (including history of or presence of angina, exertional dyspnea, orthopnea, congestive heart failure or myocardial infarction and thrombotic or embolic episode requiring treatment), hematological (including pancytopenia, aplastic anemia or blood dyscrasia and coagulopathies, or an international normalized ratio (INR) \>1.5), or metabolic disorders (including known diabetes mellitus) considered significant by the investigator. This criterion includes any disorder or condition that in the investigator's opinion may interfere with the safety of the participant, the study evaluations, or the participant's compliance to the study procedures and limitations. 15. Impaired hepatic function (alanine transaminase \[ALT\] or aspartate transaminase \[AST\] level \>1.5× times upper limit of normal \[ULN\] and/or serum total bilirubin 1.5× ULN at screening). A single repeat test on a different day is allowed. Participants with documented evidence of presence of Gilbert's disease may be included if total bilirubin is 80% of the total bilirubin as per laboratory test. 16. Participants with HbA1c \>= 6.5%, indicative of diabetes mellitus 17. Presence of any active infection assessed by the investigator even if minor and ongoing at the time of screening or on check-in day or presence of any non-healed wound or bone fracture of a clinically relevant size in the investigator's opinion. 18. Participation in an interventional or phase 1 study in the last 3 months before enrollment, participation in more than 3 studies on experimental drug products in the past 12 months, intake of an investigational drug in a clinical trial setting within 3 months or 5 half-lives (whichever is longer) prior to intake of study drug in this trial, planned intake of an investigational drug with follow up visit scheduled during the course of this trial, or intake for any reason in the last 6 months of some specific long-body residence drugs such as any immunoglobulin or antibody. 19. History of any cancer, including carcinoma in situ, lymphoma, or leukemia. 20. Major surgery within the past 6 months or any surgery including dental interventions within 3 months before study enrollment. 21. Intake of any medication including herbal products, vaccines, or immunomodulators within 3 weeks prior to study intervention administration other than nonsteroidal anti-inflammatory drugs (NSAIDs). If any other drugs have been used, there should not be any evidence of potential drug-drug interaction with abatacept. 22. Current smokers or those who have given up smoking including use of alternative tobacco products such as chewing tobacco and vaping \<=2 weeks prior to screening, or participants with positive urine cotinine test at screening or check-in. 23. Positive alcohol breath test or positive urine test for drugs of abuse (including benzodiazepines, amphetamines, barbiturates, cocaine, methadone, phencyclidine, 3,4-methylenedioxymethamphetamine, tetrahydrocannabinol, and opiates) at screening or at check-in.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Healthy volunteers are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

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.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Momentum Clinical Research

    Auckland, New Zealand

  • New Zealand Clinical Research

    Auckland, New Zealand

  • New Zealand Clinical Research

    Christchurch, New Zealand

More trials for these conditions

Other studies related to the condition(s) this trial covers.