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Healthy volunteers test two versions of Immune-Boosting drug

NCT ID NCT07416955

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested two different ways to give the same drug (pegfilgrastim) to 180 healthy adults. One version uses a pre-filled syringe, the other an auto-injector. The goal was to see if the body absorbs and handles them the same way, and to check for side effects. No treatment was given for any disease—this was purely to compare the two delivery methods.

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

180 people

The number who actually took part.

Started

Apr 2025

Finished

Oct 2025

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 55 years

Sex

Anyone

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. Age: 18 to 55 years of age, both inclusive, at the time of consent. 2. Gender: Male and/or non-pregnant, non-lactating female. 3. Willing to provide written informed consent to participate in the study. 4. Able to communicate effectively with study personnel. 5. Subject having weight greater than or equal to 50 kg 6. BMI: 19.0 to 30.0 kg/m2, both inclusive 7. Non-smoker and non-tobacco/non-nicotine user (i.e., having no past history of smoking and tobacco/nicotine consuming for at least one year prior to screening). 8. Alcohol breathalyzer test result must be negative during screening and prior to Period 1 dosing. 9. Negative urine drug screen including amphetamine/methamphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiates, methadone and phencyclidine during screening and prior to Period 1 dosing. 10. The subject has a normal ECG (12 leads) as per the investigator judgement, at screening and on admission day (before admission) of period 1. 11. Subject complies with injection site evaluation at screening and on admission day (before admission) of period 1. 12. The subject result of hemoglobin is within normal range or ± 5% of medical lab reference range at screening Exclusion Criteria: 1. History of antibodies or allergic responses to pegfilgrastim, filgrastim or other GCSF stimulant medications or other related drugs, or any of its formulation ingredients. 2. Any infection, cough or fever or suffered an acute illness within 1 week prior to first study drug administration. 3. Subject having hematologic laboratory abnormalities 4. The subject has been hospitalized within three months before the study or during the study 5. The subject has been participating in any clinical study (e.g., pharmacokinetics, bioavailability and bioequivalence studies) within the last 30 days prior to the present study 6. Clinically significant vital sign abnormalities 7. Positive hepatitis screen (includes subtypes B \& C) and/or a positive test result for HIV antibody. 8. Study participants who have received a known investigational drug within 30 days or within seven elimination half-lives of the administered drug prior to the initial dose of study drug, whichever is greater. 9. Study participant who has donated blood and/or had a blood loss of approximately 1 unit or 450 mL within 90 days prior to the initial dosing of the study drug and/or study participant who had blood loss, excluding volume drawn at screening for this study, prior to initial dosing of study drug, whichever is greater 10. Study participant who has a condition or is taking or has taken a medication that, in the Investigator's judgment, makes the study participant ineligible or places the study participant at undue risk 11. Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, could contraindicate the study participant's participation in this study. 12. Unavailable for any confinement days or scheduled visits.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Cliantha Research

    St. Petersburg, Florida, 33714, United States

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