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Can a new biosimilar match Neulasta's power to rebuild white blood cells?

NCT ID NCT07738991

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 31, 2026 · Last updated Jul 31, 2026

Summary

This trial is testing whether an experimental drug called NKF-PEG works in the same way as the approved medicine Neulasta. Both are designed to help the body produce more white blood cells, which are important for fighting infection. Healthy adult male volunteers will receive a single injection of each drug at different times, and researchers will compare how the drugs are absorbed and how strongly they stimulate white blood cell production. The goal is to see if NKF-PEG could be a similar, potentially more affordable alternative to Neulasta.

What this could mean

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

Active substance
NKF-PEG (a pegfilgrastim biosimilar candidate) compared to US-Neulasta (pegfilgrastim)
What this could lead to
If NKF-PEG proves similar to Neulasta, it could become a more affordable option to help cancer patients recover white blood cell counts after chemotherapy.
What could go wrong
This is an early-stage trial in healthy volunteers, so results may not predict real-world effectiveness in patients. There are also risks like bone pain and allergic reactions.
Why investors are watching

Nanjing King-Friend Biochemical Pharmaceutical is testing NKF-PEG, its version of the cancer-support drug Neulasta, in a Phase 1 trial with 202 healthy volunteers. The trial checks whether NKF-PEG works in the body the same way as the US-approved Neulasta and is safe. For a small company, this readout matters because it is the first step toward showing its drug can compete with a major existing product.

If it works: If the trial shows NKF-PEG matches Neulasta in how the body absorbs and responds to it, the company could move to larger studies and eventually seek approval to sell its own version. That would give it a product to market in a field with established demand.

If it fails: Phase 1 trials often fail to show the expected similarity or reveal safety problems, which would force the company to redesign or abandon the drug. A delay in results could also slow the company's progress and raise costs without any guarantee of success.

AI-written from the trial record. Speculative, and not investment advice.

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 202 people

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

Started

Jul 2026

Expected to finish

Apr 2027

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 55 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. Participant must be 18 to 55 years of age, at the time of signing the informed consent. 2. Body weight ≥ 50 kg and body mass index (BMI) within the range 18.5-30.0 kg/m2 (inclusive). 3. Male assigned at birth, inclusive of all gender identities. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. a. Male participants: Participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: •Refrain from donating sperm PLUS, either: Be abstinent from intercourse where pregnancy can occur (abstinent on a long term and persistent basis) and agree to remain abstinent. OR Must agree to use contraception as detailed below: Agree to use birth control (2 highly effective methods of contraception including 1 barrier method) when having sexual intercourse with a partner able to give birth who is not currently pregnant. 4. Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 5. Willingness to follow protocol defined restrictions and Investigator/staff instructions and protocol procedures. Exclusion Criteria: 1. Sensitivity to any of the study interventions, or components thereof including E. coli derived proteins, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study. 2. With any clinically significant abnormalities identified during screening in physical examination, vital signs, laboratory tests, or 12-lead ECG. 3. History or presence of cardiovascular, respiratory, psychiatric, metabolic, hepatic, renal, gastrointestinal, endocrinological, hematological, oncological, or neurological disorders determined to be clinically significant by the Investigator. 4. Evidence of active infection, including chronic or localized infections, by history, physical examination findings, or laboratory data, as determined by the Investigator within 1 week prior to Day 1. 5. Rash, scarring, dermatological condition, or tattoo in the area of the injection site that could interfere with the injection or injection site assessment. 6. History or presence of any condition that in the opinion of the Investigator would constitute a risk when taking the study intervention or interfere with the interpretation of data. 7. A history of alcohol abuse within 3 months prior to screening (alcohol consumption of more than 14 units per week: 1 unit of alcohol = 285 mL beer, or 25 mL spirits, or 100 mL wine).

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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

    1 site. 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

  • Ethics Committee of Hopeshine-Minsheng Hospital of Xinzheng, Zhengzhou,

    RECRUITING

    Zhengzhou, China

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