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Healthy Adult ParticipantsPhase 1NCT07921966

Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants

A Phase 1 study testing NRL-1004 2.5 mg, ZYPREXA IM 10mg and NRL-1004 5.0 mg in people with Healthy Adult Participants, run by Neurelis, Inc..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a Phase 1, open-label, 5-period, 2-sequence, single ascending dose study designed to assess the pharmacokinetics, dose proportionality, safety, and tolerability of NRL-1004 (olanzapine nasal spray), and to assess the relative bioavailability of NRL-1004, compared to olanzapine intramuscular injection (ZYPREXA… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Adult Participants
What is being tested?
NRL-1004 2.5 mg, ZYPREXA IM 10mg and NRL-1004 5.0 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
No sites listed yet
Study dates
16 Oct 2026to 14 Jan 2027
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • A participant will be eligible for study participation if the participant meets all of the following criteria:
  • Male and female participants aged between 18 to 65 years, inclusive.
  • Body weight ≥50 kg and body mass index (BMI) within the range of 18.0 to 30.0 kg/m2 (inclusive).
  • Participants must be healthy and without clinically significant abnormalities as assessed at screening and at first CRU admission visit.
  • No clinically significant abnormality on 12-lead ECG.
  • Normal blood pressures and pulse rate at screening and at first CRU admission visit.
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  • If male, meets one of the following criteria:
  • Is able to procreate and agrees to use one of the accepted contraceptive regimens and not to donate sperm from the first study drug administration to at least 90 days after the last drug administration.
  • Is unable to procreate; defined as surgically sterile
  • If female, meets one of the following criteria:
  • Is of childbearing potential and agrees to use an acceptable contraceptive method.
  • Is of non-childbearing potential, defined as surgically sterile or is in a postmenopausal state.

Who cannot join

  • A participant will be excluded from the study if the participant meets any of the following criteria:
  • Female who is pregnant or plans to become pregnant, or who is lactating or plans to be lactating during the study.
  • Clinically significant cardiac, cardio- or cerebrovascular, respiratory, gastrointestinal, endocrine, hematologic, psychiatric, renal, hepatic, pulmonary, immunologic, dermatologic or nervous system disorders.
  • History of or current postural orthostatic tachycardia syndrome, or orthostatic hypotension at screening and at first CRU admission.
  • Current or history of psychiatric or psychotic diagnosis.
  • Evidence or history of suicidal ideation as per the C-SSRS administered at screening and at first CRU admission, violence, or homicidality.
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  • Major surgery or open biopsy within 90 days prior to screening or expected/scheduled to have such procedure(s) performed during the study.
  • Any other conditions or unstable diseases/disorders which may affect the ability of the participant to comply with the protocol requirements, jeopardize the safety of the participant, or impact the interpretation of the study results.
  • Any clinical or laboratory measurements assessed by the Investigator as clinically relevant.
  • Positive blood screen for human immunodeficiency virus (HIV-1/2), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (HCV Ab) at screening.
  • History of drug abuse or alcohol abuse within 12 months prior to Screening, and/or unwilling to refrain from such use throughout the study.
  • History of smoking or use of tobacco or other nicotine-containing products within 3 months prior to screening and unwilling to refrain throughout the study.
  • Use of medical or recreational cannabinoid use and unwilling to refrain throughout the study.
  • Positive drug screen for alcohol, cotinine, or illicit drug/substance of abuse.
  • Presence of acute conditions that could interfere with IN administration and drug absorption.
  • National Institute of Health (NIH) Toolbox Odor Identification test score of 0 at screening.
  • Current use of any drugs that may affect the absorption, metabolism, or elimination of study drugs, and that such treatment cannot be discontinued at least 4 weeks prior to screening and throughout the study.
  • Unwilling to refrain from intake of food or consumption of caffeine-containing drinks that affect CYP1A2 activity throughout the course of the study.
  • Use of any prescription medication within 14 days or 5 half-lives prior to the first dose of study drug or during the study unless approved by the Investigator. (Hormonal contraceptives or hormone replacement therapy are allowed.)
  • Use of any over-the-counter medications within 14 days or 5 half lives prior to Screening and throughout the study unless approved by the Investigator.
  • History of hypersensitivity or anaphylactic reactions to the active ingredient or any excipients of study drugs.
  • Received an investigational drug within 30 days or within 5 half-lives or twice the duration of the biological effect of the investigational drug in previous study prior to screening.
  • Inadequate or difficult venous access.
  • Donation of plasma in the 7 days prior to the first study drug administration, or donation of 500 mL or more of blood in the 56 days prior to the first study drug administration.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Stella Ngo, PhD contact

(908) 499-2326

sngo@neurelis.com

About this study

Official title: A Phase 1, Open-Label, Two-Sequence, Five-Period, Single Ascending Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Intranasal Olanzapine and Relative Bioavailability Compared to Olanzapine Intramuscular Injection in Healthy Adult Participants

This is a Phase 1, open-label, 5-period, 2-sequence, single ascending dose study designed to assess the pharmacokinetics, dose proportionality, safety, and tolerability of NRL-1004 (olanzapine nasal spray), and to assess the relative bioavailability of NRL-1004, compared to olanzapine intramuscular injection (ZYPREXA IM), in healthy adult participants. The study will be conducted in a single clinical research unit (CRU).

Being tested
NRL-1004 2.5 mg, ZYPREXA IM 10mg, NRL-1004 5.0 mg, NRL-1004 7.5 mg, NRL-1004 10.0 mg
Keywords
Agitation, Bipolar mania, Bipolar disorder, antipsychotic, Bipolar I, Schizoaffective disorder, Schizophrenia, psychomotor
Medical subject headings
Psychomotor Agitation, Bipolar Disorder, Psychotic Disorders, Schizophrenia

What participants receive

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

  • NRL-1004 2.5 mgDrug

    Olanzapine nasal spray

  • ZYPREXA IM 10mgDrug

    Olanzapine IM injection

  • NRL-1004 5.0 mgDrug

    Olanzapine nasal spray

  • NRL-1004 7.5 mgDrug

    Olanzapine nasal spray

  • NRL-1004 10.0 mgDrug

    Olanzapine nasal spray

Study groups in NCT07921966
Study groupRoleWhat they receive
NRL 1004 25 mg/mL solutionExperimentalNRL-1004 (olanzapine nasal spray), 25 mg/mL solution
Receives: Drug: NRL-1004 2.5 mg
NRL-1004 50 mg/mL solutionExperimentalNRL-1004 (olanzapine nasal spray), 50 mg/mL solution
Receives: Drug: NRL-1004 5.0 mg
NRL-1004 75 mg/mL solutionExperimentalNRL-1004 (olanzapine nasal spray), 75 mg/mL solution
Receives: Drug: NRL-1004 7.5 mg
NRL-1004 100 mg/mL solutionExperimentalNRL-1004 (olanzapine nasal spray), 100 mg/mL solution
Receives: Drug: NRL-1004 10.0 mg
ZYPREXA IM 10mg/vialActive comparatorZYPREXA IntraMuscular (olanzapine) Injection, Powder, for Solution for Intramuscular use, 10 mg/vial
Receives: Drug: ZYPREXA IM 10mg

What is being measured

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

  1. Pharmacokinetic parameters of olanzapine in plasma

    Maximum observed plasma concentration (Cmax)

    Measured: Time zero to 14 days postdose

  2. Pharmacokinetic parameters of olanzapine in plasma

    Time to maximum plasma concentration (Tmax)

    Measured: Time zero to 14 days postdose

  3. Pharmacokinetic parameters of olanzapine in plasma

    Area under the plasma concentration time curve (AUC) from time zero to the last quantifiable concentration (AUC0-t)

    Measured: Time zero to 14 days postdose

  4. Pharmacokinetic parameters of olanzapine in plasma

    AUC from time zero extrapolated to infinity (AUC0-inf)

    Measured: Time zero to 14 days postdose

  5. Pharmacokinetic parameters of olanzapine in plasma

    Partial AUC from time zero to 2 hours postdose (AUC0-2 h)

    Measured: Time zero to 14 days postdose

  6. Pharmacokinetic parameters of olanzapine in plasma

    Partial AUC from time zero to 24 hours postdose (AUC0-24 h)

    Measured: Time zero to 14 days postdose

  7. Pharmacokinetic parameters of olanzapine in plasma

    Terminal phase half-life (t½)

    Measured: Time zero to 14 days postdose

  8. Pharmacokinetic parameters of olanzapine in plasma

    Terminal phase rate constant (λz)

    Measured: Time zero to 14 days postdose

  9. Pharmacokinetic parameters of olanzapine in plasma

    Apparent clearance (CL/F)

    Measured: Time zero to 14 days postdose

  10. Pharmacokinetic parameters of olanzapine in plasma

    Apparent volume of distribution (Vz/F)

    Measured: Time zero to 14 days postdose

  11. Pharmacokinetic parameters of olanzapine in plasma

    Relative bioavailability (Frel)

    Measured: Time zero to 14 days postdose

Timeline

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

  1. First posted6 Nov 2026
  2. Study start16 Oct 2026 (estimated)
  3. Primary completion14 Jan 2027 (estimated)
  4. Study completion14 Jan 2027 (estimated)

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
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07921966
Sponsor's protocol ID
OLAN.001.02
Status last verified
Nov 2026
First submitted
26 Oct 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NRL-1004 2.5 mg, ZYPREXA IM 10mg and NRL-1004 5.0 mg in people with Healthy Adult Participants, run by Neurelis, Inc..

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 12 inclusion and 24 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: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 Stella Ngo, PhD ((908) 499-2326, sngo@neurelis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetic parameters of olanzapine in plasma (time frame: Time zero to 14 days postdose). The study lists 11 primary outcomes in all. 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 NCT07921966.

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 6 Nov 2026.

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