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Myocardial InfarctionPhase 1NCT05387499

A Study of NP-011 in Healthy Volunteers

A Phase 1 study testing NP-011 (Single Ascending Dose Phase) and NP-011 (Multiple Ascending Dose Phase) in people with Myocardial Infarction, run by Nexel Co., Ltd. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase 1, randomised, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study to evaluate the safety, tolerability, and pharmacokinetic of NP-011 in healthy volunteers. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Myocardial Infarction
What is being tested?
NP-011 (Single Ascending Dose Phase) and NP-011 (Multiple Ascending Dose Phase)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
64 participants
Where
1 siteAustralia
Study dates
10 Jun 2022to 26 May 2023
Phase
Phase 1
Are there results?
None posted in the registry

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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Normal healthy volunteers with an age of 18 to 65 years inclusive at the time of informed consent.
  • Participants can be of any ethnicity or race, excluding Asian by self-declaration. For the purposes of this protocol, Asian is defined as a person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent, including for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, Philippines, Thailand, and Vietnam. If an individual identifies as mixed race, exclusion will occur if the proportion of self-declaration as Asian exceeds 25%.
  • Participants must be in good general health, in the opinion of the Investigator, with no significant medical history (ie, history of childhood asthma [resolved] is acceptable; history of depression [non-hospitalised, medicated] or migraines is not acceptable), and no clinically significant abnormalities on physical examination at Screening and/or before administration of the initial dose of IP.
  • Participants must have documented evidence of receipt of licensed COVID-19 vaccinations as per the current Australian Technical Advisory Group on Immunisation (ATAGI) guidelines and be fully vaccinated as per local guidelines.
  • Participants must have a BMI between > 18.0 and < 32.0 kg/m2 at Screening.
  • Participants must have clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the Investigator or delegate. A single repeat test can be performed for clinically significant abnormal values, at the discretion of the Investigator.
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  • Participants must be a non-smoker and must not have used any tobacco products within 2 months prior to Screening, or if a smoker, they must smoke no more than 2 cigarettes or equivalent per week.
  • Participants must have no relevant dietary restrictions (restrictions that would prevent consumption of the standard meals to be provided), and be willing to consume standard meals provided.
  • Females must be non-pregnant and non-lactating, and must use an acceptable, highly effective double contraception from Screening until 30 days after last dose of IP, including the follow-up period. Double contraception is defined as a condom AND one other form of the following:
  • Established hormonal contraception (with approved oral contraceptive pills [OCPs], long-acting implantable hormones, injectable hormones);
  • A vaginal ring or an intrauterine device (IUD);
  • Documented evidence of surgical sterilisation at least 6 months prior to Screening (eg, tubal occlusion, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy for women or vasectomy for men, provided the male partner is a sole partner).
  • Women not of childbearing potential must be post-menopausal for ≥ 12 months. Post-menopausal status will be confirmed through testing of follicle-stimulating hormone (FSH) levels ≥ 40 IU/L at Screening for amenorrhoeic female participants. Females who are abstinent from heterosexual intercourse will also be eligible.
  • Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not considered highly effective methods of birth control. Participant complete abstinence for the duration of the study and for 1 month after the last study treatment is acceptable.
  • Female participants who are in exclusively same-sex relationships are not required to use contraception.
  • Woman of childbearing potential (WOCBP) must have a negative pregnancy test at Screening and Day 1 and be willing to have additional pregnancy tests as required throughout the study.
  • Males must be surgically sterile (> 30 days since vasectomy with no viable sperm), abstinent, or if engaged in sexual relations with a WOCBP, the participant and his partner must be surgically sterile (eg, tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or using an acceptable, highly effective contraceptive method from Screening until study completion, including the follow-up period, and for at least 90 days post final dose. Acceptable methods of contraception include the use of condoms and the use of an effective contraceptive for the female partner that includes: OCPs, long-acting implantable hormones, injectable hormones, a vaginal ring, or an IUD. Participants with same-sex partners (abstinence from penile-vaginal intercourse) are eligible when this is their preferred and usual lifestyle.
  • Male participants must not donate sperm for at least 90 days after the last dose of IP, and female participants must not donate ovum for at least 30 days after the last dose of IP.

Who cannot join

  • Use of any IP or investigational medicinal device within 30 days prior to treatment, or 5 half-lives of the product, whichever is the longest.
  • Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the Investigator's opinion, could adversely affect the safety of the participant or confound treatment assessment.
  • Allergy or hypersensitivity to the IP or any of its constituents.
  • History of allergic or anaphylactic reactions that are considered severe in the opinion of the Investigator (with the allowance of well-managed allergies such as allergic rhinitis, eczema, stinging insect allergies, and pollen allergies).
  • Any history of cardiac disease.
  • Abnormal ECG findings at Screening that are considered by the Investigator to be clinically significant.
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  • Use of or anticipated use of any prescription drugs (other than hormonal contraception; OCPs, long-acting implantable hormones, injectable hormones, a vaginal ring, or an IUD), over-the-counter (OTC) medication, herbal remedies, supplements, or vitamins 2 weeks prior to dosing and during course of study without prior approval of the Investigator and MM. Simple analgesics (paracetamol, nonsteroidal anti-inflammatory drugs [NSAIDs]) are permitted at 1 or 2 therapeutic doses per week at the discretion of the Investigator.
  • Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period.
  • Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the participant will comply with the protocol or complete the study per protocol.
  • Blood donation or significant blood loss within 60 days prior to the first IP administration.
  • Plasma donation within 7 days prior to the first IP administration.
  • Fever (body temperature > 38°C) or symptomatic viral or bacterial infection within 2 weeks prior to Screening.
  • History of malignancy, except for non-melanoma skin cancer, excised more than 2 years ago and cervical intraepithelial neoplasia that has been successfully cured more than 5 years prior to Screening.
  • History or presence of a condition associated with significant immunosuppression (significant in the opinion of the Investigator).
  • History of life-threatening infection (eg, meningitis).

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • CMAX Clinical Research Pty Ltd

    Adelaide, South Australia, 5063

Other trials in Australia

About this study

Official title: A Phase 1, Randomised, Double-blind, Placebo-Controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of NP-011 in Healthy Volunteers

This is a Phase 1, randomised, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study to evaluate the safety, tolerability, and pharmacokinetic of NP-011 in healthy volunteers.

Read the detailed description

NP-011 is a truncated form of human MFG-E8 recombinant protein. NP-011 placebo has an identical formulation to the NP-011 drug product, prepared without the active pharmaceutical ingredient.

The study will be conducted in 2 parts:

Single Ascending Dose (SAD): The participants will be randomized to receive NP-011 (n= 6 per cohort) or placebo (n= 2 per cohort) on Day 1.

For all Part 1 cohorts, 2 sentinel participants will receive the first dose of IP (1 to receive NP-011, 1 to receive placebo) on Day 1. If dosing of the sentinel participants proceeds without clinically significant adverse events over 24 hours, the remaining participants in the cohort will be dosed at the discretion of the Principal Investigator (PI), according to the randomization schedule.

There are total five cohorts in Part 1 Cohort 1A: NP-011 250 μg or placebo (6:2) Cohort 1B: NP-011 500 μg or placebo (6:2) Cohort 1C: NP-011 1000 μg or placebo (6:2) Cohort 1D: NP-011 2000 μg or placebo (6:2) Cohort 1E: NP-011 4000 μg or placebo (6:2)

Multiple Ascending Dose (MAD): The part 2 progress after the completion of Day 8 assessments in Cohort 1E upon satisfactory review of all available safety data by the SMC.

Participants will be enrolled into 3 sequential cohorts in Part 2. Dose levels for Part 2 cohorts may be revised by agreement with the SMC and based on emerging safety and PK data.

Cohort 2A: NP-011 1000 μg or placebo (6:2) Cohort 2B: NP-011 2000 μg or placebo (6:2) Cohort 2C: NP-011 4000 μg or placebo (6:2)

The participants will be randomized to receive the NP-011 (n= 6 per cohort) or placebo (n=2 per cohort)

The safety and pharmacokinetic data will be reviewed by SMC in both the parts (SAD and MAD) prior to the decision to increase or decrease the dose level for the next cohort or expand the number of participants in a cohort (to a maximum of an additional 8 participants at a given dose level).

Being tested
NP-011 (Single Ascending Dose Phase), NP-011 (Multiple Ascending Dose Phase), NP-011 (Placebo)
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NP-011 (Single Ascending Dose Phase)Drug

    The participants will receive assigned single dose of NP-011 after a minimum 8 hour fast on Day 1

  • NP-011 (Multiple Ascending Dose Phase)Drug

    The participants will receive assigned dose of NP-011 after a minimum 8 hour fast once daily for 7 days

  • NP-011 (Placebo)Other

    The participants will receive single dose of NP-011 after a minimum 8 hour fast on Day 1 in Single Ascending Dose part and will receive once daily for 7 days after a minimum 8 hour fast in Multiple Ascending dose part of the study

Study groups in NCT05387499
Study groupRoleWhat they receive
Single Ascending Dose PhaseExperimentalDrug: NP-011 Dosage: 250μg, 500μg, 1000μg, 2000μg, 4000μg Dosage Form: Liquid for IV injection Route of Administration: Intravenous
Receives: Drug: NP-011 (Single Ascending Dose Phase)
Multiple Ascending Dose PhaseExperimentalDrug: NP-011 Dosage: 1000μg, 2000μg, 4000μg Dosage Form: Liquid for IV injection Route of Administration: Intravenous
Receives: Drug: NP-011 (Multiple Ascending Dose Phase)
PlaceboPlacebo comparatorDosage Form: Liquid for IV injection Route of Administration: Intravenous
Receives: Other: NP-011 (Placebo)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The safety and tolerability of single and multiple doses of NP-011 through the incidence, nature and severity of adverse events

    Adverse Events will be coded using the most current version of the MedDRA®

    Measured: Screening to end of the follow up period; up to 36 and 56 days for Single Ascending Dose and Multiple Ascending Dose

Secondary outcomes (4)

  1. To characterize the plasma pharmacokinetics (PK) of NP-011 in healthy volunteers

    Parameter: maximum concentration (Cmax)

    Measured: Screening to end of the follow up period; up to 36 and 56 days for Single Ascending Dose and Multiple Ascending Dose

  2. To characterize the plasma pharmacokinetics (PK) of NP-011 in healthy volunteers

    Parameter: time to maximum concentration (Tmax)

    Measured: Screening to end of the follow up period; up to 36 and 56 days for Single Ascending Dose and Multiple Ascending Dose

  3. To characterize the plasma pharmacokinetics (PK) of NP-011 in healthy volunteers

    Parameter: area under the concentration-time curve (AUC)

    Measured: Screening to end of the follow up period; up to 36 and 56 days for Single Ascending Dose and Multiple Ascending Dose

  4. To characterize the immunogenicity of NP-011 in healthy volunteers by assessing the development of anti-drug-antibodies (ADA) through change from baseline in neutralizing antibody titers for NP-011 after single and multiple doses.

    Measured: Screening to end of the follow up period; up to 36 and 56 days for Single Ascending Dose and Multiple Ascending Dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2022
  2. Study start10 Jun 2022
  3. Primary completion7 Mar 2023
  4. Study completion26 May 2023

Resources

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
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05387499
Sponsor's protocol ID
NP-011-001
Status last verified
Mar 2023
First submitted
4 May 2022
Last updated
3 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lee H, Tran QT, Tham BT, Kim MK, Yun HY, Chae JW, Park JH, Lee S. Population Pharmacokinetics and Extrapolation of NP-011 from Animal to Humans: A Novel Therapeutic Candidate Protein for Metabolic Dysfunction-Associated Steatohepatitis. Pharmaceutics. 2026 Sep 21;18(9):1194. doi: 10.3390/pharmaceutics18091194.

    PubMed 42797369

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NP-011 (Single Ascending Dose Phase) and NP-011 (Multiple Ascending Dose Phase) in people with Myocardial Infarction, run by Nexel Co., Ltd. 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 18 inclusion and 15 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: finished, as of the sponsor's last update on 3 Aug 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The safety and tolerability of single and multiple doses of NP-011 through the incidence, nature and severity of adverse events (time frame: Screening to end of the follow up period; up to 36 and 56 days for Single Ascending Dose and Multiple Ascending Dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05387499, which also lists 1 linked publication.

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 3 Aug 2023.

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