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Healthy Adult VolunteersPhase 1NCT06681389

A Study of NP-201 Acetate Injection in Healthy Adult Volunteers and in Patients With Mild-To-Moderate Active Ulcerative Colitis

A Phase 1 study testing NP-201 acetate injection (Part A) in people with Healthy Adult Volunteers and Active Ulcerative Colitis, run by NIBEC Co., Ltd. at 1 site in Australia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This Phase 1b/2a clinical development plan is focused on the use of NP-201 acetate injection to investigate the pharmacokinetics (PK), safety, efficacy, PD (pharmacodynamic) markers (Phase 1b) and tolerability of NP-201 acetate injection after subcutaneous (SC) injection of multiple doses in healthy adults and in the… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
What is being tested?
NP-201 acetate injection (Part A)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
35 participants
Where
1 siteAustralia
Study dates
25 Nov 2024to 4 Sep 2025
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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy males and females, between 18 to 60 years inclusive, at the time of Screening.
  • Body mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2(inclusive), at Screening, with a minimum body weight of 50 kg
  • In good health based on the results of medical history, physical examinations, 12-lead ECG, vital signs measurement, and clinical laboratory evaluations at Screening, as assessed by the PI or designee.
  • All female participants of childbearing potential with male sexual partners and male participants with female sexual partners of childbearing potential must consent to use two highly effective methods of contraception from start of study and for at least 90 days (male and female participants) following the EOS visit or last dose of study treatment, whichever is later. Male participants must refrain from sperm donation from start of study and for 90 days after last dose of IP; female participants must refrain from donation of ova from start of study and for 30 days after last dose of IP. WOCBP must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Screening, and be willing to undergo additional pregnancy tests, as required, throughout the study. Women not of childbearing potential must be postmenopausal (defined as cessation of regular menstrual periods for at least 12 months without an alternative medical cause), confirmed by follicle-stimulating hormone (FSH) level >40 IU/mL at Screening.
  • Participants whose smoking habit in the last 3 months prior to Screening included no more than 14 cigarettes per week (includes e-cigarettes and other nicotine and tobacco products) can be included in the study but must be willing to abstain from smoking from Screening until completion of the EOS visit (Part A only).
  • Ability and willingness to restrict the use of alcohol to ≤ 21 units per week for males and ≤ 14 units per week for females. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits. Participants must have negative alcohol breath tests at Screening and Day -1 visits.
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  • Participants who are able to receive SC injections specifically participants who have scars or tattoos in the area of concern.
  • Participants must participate voluntarily, sign the ICF, have good compliance, be able and willing to attend the necessary site visits and be willing to cooperate with follow-up visits.
  • No history of severe allergic or anaphylactic reactions, including known allergies or hypersensitivities to NP-201 acetate or its excipients.

Who cannot join

  • Have a clinically significant medical history or surgical history and have at least one of the following findings:
  • Have skin diseases that may affect the absorption of the IP (eg, psoriasis, contact dermatitis), scars, tattoos, and skin abnormalities that may interfere with SC injections, or a history of surgery within 60 days of Screening (except for simple appendectomy or hernia repair, as assessed by the PI or designee).
  • Have a recent significant history of kidney diseases, pancreatitis and/ or nephrolithiasis.
  • Participants with liver cirrhosis accompanying edema and/or ascites.
  • Have known clinically significant allergies as assessed by the PI or designee, diseases of either/or the cardiovascular system, peripheral vascular system, skin, mucous membranes, eyes, respiratory system, musculoskeletal system, and/or any other diseases that may pose a problem with the PK evaluation. History of childhood asthma can be included at the discretion of the PI or designee.
  • Presence of any underlying physical, or psychological medical condition that, in the opinion of the PI or designee, will make it unlikely that the participant will comply with the protocol, or complete the study per the protocol.
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  • Pregnant or lactating at Screening or planning to become pregnant at any time during the study, including the follow-up period.
  • Have a clinically relevant history of hypersensitivity reactions or allergic reactions to drugs (such as aspirin and antibiotics), or known drug allergies (eg, to aspirin, nonsteroidal anti-inflammatory drugs [NSAIDs], antibiotics, iodine, anesthetics, other monoclonal antibodies, etc.).
  • Participants who have donated whole blood within 60 days prior to Screening or blood components within 30 days or received blood transfusion within 60 days.
  • Have received an IP or bioequivalence IP in another clinical study or bioequivalence study within 30 days prior to Screening or five half-lives prior to Screening.
  • Use of any prescription drugs within 14 days prior to dosing or non-prescription medications/products, including vitamins, minerals, and phyto-therapeutic/herbal/plant-derived preparations, alternative medicines, or dietary supplements within 7days prior to dosing (at the discretion of the PI or designee). The occasional use of paracetamol(up to 2g/day) is permitted.
  • History of alcoholism, substance or drug abuse-related disorders deemed significant by the PI or designee.
  • Participants with a positive toxicology screening panel. Positive test may be repeated once at the discretion of the investigator.
  • Have positive serology test (hepatitis B surface antigen [HBsAg], or hepatitis C virus antibody [anti-HCV], human immunodeficiency virus [HIV] test,) at Screening.
  • Active infection requiring medical treatment and/or isolation at the time of Screening.
  • Alanine transaminase (ALT), alkaline phosphatase (ALP), aspartate transaminase (AST) > 2.0 × upper limit of normal (ULN).
  • Bilirubin > 1.5 × ULN (isolated bilirubin > 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%).
  • QTcF > 450 msec for male participants or QTcF > 470 msec for female participants. The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF).
  • Participants with corrected calcium (Ca) > ULN, uric acid > ULN, and/or estimated glomerular filtration rate < 90 mL/min, calculated using Cockroft Gault formula.
  • Others who are ineligible to participate in this clinical study as determined by the PI or designee.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • CMAX Clinical Research Pty Ltd

    Adelaide, South Australia, 5000

Other trials in Australia

About this study

Official title: A Randomized, Double-Blind Phase1b/2a Clinical Study to Evaluate Efficacy, Safety and Tolerability of Subcutaneous Administration of NP-201 Acetate Injection in Healthy Adult Volunteers and in Patients With Mild-To-Moderate Active Ulcerative Colitis

This Phase 1b/2a clinical development plan is focused on the use of NP-201 acetate injection to investigate the pharmacokinetics (PK), safety, efficacy, PD (pharmacodynamic) markers (Phase 1b) and tolerability of NP-201 acetate injection after subcutaneous (SC) injection of multiple doses in healthy adults and in the ulcerative colitis (UC) patient population.

Read the detailed description

This Phase 1b/2a randomized, double-blinded study will be conducted in two parts - Phase 1b (Part A) in healthy volunteers and Phase 2a (Part B) in UC patients. This record relates only to Part A/Phase 1b study. This will be updated once Part A is complete.

Part A (Multiple Ascending Doses-MAD): Up to a total of 32 healthy participants will be enrolled into four sequential cohorts (MAD1, MAD2, MAD3 and MAD4) and randomized 6:2 to receive either two dosing regimens of NP-201 acetate injection or placebo daily for 5 days or for MAD cohort 4 will be randomized 6:2 to receive 4 weekly doses of NP-201 acetate injection or placebo.

Being tested
NP-201 acetate injection (Part A), Placebo
Keywords
Mild-To-Moderate Active Ulcerative Colitis, Ulcerative Colitis, Active Ulcerative Colitis, active ulcerative colitis (UC)
Medical subject headings
Colitis, Ulcerative

What participants receive

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

  • NP-201 acetate injection (Part A)Drug

    Route of administration- Sub cutaneous. Dosage interval and frequency: MAD1-200mg daily for 5 days; MAD2- 300mg daily for 5 days, MAD3- 400mg daily for 5 days, MAD4- 400mg administered 4 weekly doses.

  • PlaceboDrug

    Matching placebo administered across Part A and Part B

Study groups in NCT06681389
Study groupRoleWhat they receive
NP-201 Acetate Injection- Part AExperimental32 healthy participants across 4 cohorts will receive NP-201 acetate injection
Receives: Drug: NP-201 acetate injection (Part A)
PlaceboPlacebo comparatorMatching placebo
Receives: Drug: Placebo

What is being measured

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

  1. Safety of NP-201 acetate injection in Healthy Volunteers. To evaluate the safety of NP-201 acetate injection by incidence, relationship and severity of adverse events (AE), serious adverse events and Treatment emergent AE

    Measured: Part A-Screening to Day 12 post first dose administration

  2. Safety of NP-201 acetate injection in Healthy Volunteers. To evaluate the safety of NP-201 acetate injection by changes in baseline Laboratory values

    Measured: Part A-Screening to Day 12 post first dose administration

  3. Part A-Plasma PK parameters following multiple doses of NP-201 acetate injection- AUC from time 0 to 24 (AUC24)

    Measured: Part A-Samples collected on Day 1, Day 2, Day 5 and Day 6 post first dose administration

  4. Part A-Plasma PK parameters following multiple doses of NP-201 acetate injection- AUC over the dosing interval (AUCtau)

    Measured: Part A-Samples collected on Day 1, Day 2, Day 5 and Day 6 post first dose administration

  5. Part A-Plasma PK parameters following multiple doses of NP-201 acetate injection- Area under curve from 0 to last AUC(0-last)

    Measured: Part A-Samples collected on Day 1, Day 2, Day 5 and Day 6 post first dose administration

  6. Part A-Plasma PK parameters following multiple doses of NP-201 acetate injection- Maximum plasma concentration at steadystate (Cmax,ss)

    Measured: Part A-Samples collected on Day 1, Day 2, Day 5 and Day 6 post first dose administration

  7. Part A-Plasma PK parameters following multiple doses of NP-201 acetate injection- time to Cmax,ss (tmax,ss)

    Measured: Part A-Samples collected on Day 1, Day 2, Day 5 and Day 6 post first dose administration

  8. Part A-Plasma PK parameters following multiple doses of NP-201 acetate injection- Apparent oral body clearance at steady-state (CL/Fss)

    Measured: Part A-Samples collected on Day 1, Day 2, Day 5 and Day 6 post first dose administration

  9. Part A-Plasma PK parameters following multiple doses of NP-201 acetate injection- Apparent volume of distribution at steady-state (Vd/Fss)

    Measured: Part A- Samples collected on Day 1, Day 2, Day 5 and Day 6 post first dose administration

  10. Part A-Plasma PK parameters following multiple doses of NP-201 acetate injection-Terminal half life (t1/2)

    Measured: Part A-Samples collected on Day 1, Day 2, Day 5 and Day 6 post first dose administration

  11. Part A-Urine PK parameters of NP-201 acetate injection after multiple doses- cumulative amount of drug excreted in urine (Ae)

    Measured: Part A-Samples collected on Day 1 and Day 5 post first dose administration

  12. Part A-Urine PK parameters of NP-201 acetate injection after multiple doses- percent fraction of drug recovered in urine (Fe)

    Measured: Part A-Samples collected on Day 1 and Day 5 post first dose adminstration

  13. Part A-Urine PK parameters of NP-201 acetate injection after multiple doses- Renal clearance (CLr)

    Measured: Part A-Samples collected on Day 1 and Day 5 post first dose adminstration

  14. Area Under the Plasma Concentration-Time Curve (AUC)

    Area under the plasma concentration-time curve (AUC) of NP-201 following subcutaneous administration at multiple dose levels.

    Measured: Day 1, Day 8, Day 15, Day 22, Day 29, Day 30 (24 hours post-dose), Day 43

  15. Peak Plasma Concentration (Cmax)

    Maximum observed plasma concentration (Cmax) of NP-201 following subcutaneous administration at multiple dose levels.

    Measured: Day 1, Day 8, Day 15, Day 22, Day 29, Day 30 (24 hours post-dose), Day 43

  16. Time to Reach Maximum Plasma Concentration (Tmax)

    Time to reach maximum plasma concentration (Tmax) of NP-201 following subcutaneous administration at multiple dose levels

    Measured: Day 1, Day 8, Day 15, Day 22, Day 29

  17. Apparent Clearance (CL/F)

    Apparent clearance (CL/F) of NP-201 following subcutaneous administration at multiple dose levels.

    Measured: Day 30, Day 43

  18. Apparent Volume of Distribution (Vd/F)

    Apparent volume of distribution (Vd/F) of NP-201 following subcutaneous administration at multiple dose levels

    Measured: Day 30, Day 43

  19. Terminal Half-life (t½)

    Terminal elimination half-life (t½) of NP-201 following subcutaneous administration at multiple dose levels.

    Measured: Day 30, Day 43

  20. Renal Clearance (Clr)

    Renal clearance (Clr) of NP-201 following subcutaneous administration at multiple dose levels.

    Measured: Day 1 and Day 29

  21. Amount Excreted in Urine (Ae)

    Total amount of NP-201 excreted in urine following subcutaneous administration at multiple dose levels.

    Measured: Day 1 and Day 29

  22. Fraction of Dose Excreted in Urine (Fe)

    Fraction of administered dose excreted in urine (Fe) following subcutaneous administration at multiple dose levels.

    Measured: Day 1 and Day 29

  23. Part A-Immunogenicity (ADA) in Cohort MAD4

    To assess presence of anti-drug antibodies following repeated weekly SC injections.

    Measured: Day 1 (pre-dose), Day 15, Day 29, and Day 43

Secondary outcomes (13)

  1. Part A- PK of NP-201 acetate injection metabolite- AUC from time 0 to 24 (AUC24)

    Plasma Pharmacokinetics in Healthy Volunteers following administration of multiple doses of NP-201 acetate injection by measuring the NP-201 acetate injection metabolite Area under the concentration- time curve from 0 to 24hrs (AUC24)

    Measured: Part A- Samples collected on Day 1, Day 2, Day 5 and Day 6 post first dose administration

  2. Part A- PK of NP-201 acetate injection metabolite- AUC over the dosing interval (AUCtau)

    Plasma Pharmacokinetics in Healthy Volunteers following administration of multiple doses of NP-201 acetate injection by measuring the NP-201 acetate injection metabolite Area under the concentration- time curve over the dosing interval (AUCtau)

    Measured: Part A- Samples collected on Day 1, Day 2, Day 5 and Day 6 post first dose administration

  3. Part A-PK of NP-201 acetate injection metabolite- Maximum plasma concentration at steady state (Cmax,ss)

    Plasma Pharmacokinetics in Healthy Volunteers following administration of multiple doses of NP-201 acetate injection by measuring the NP-201 acetate injection metabolite maximum plasma concentration at steady state (CMAX, ss)

    Measured: Part A- Samples collected on Day 1, Day 2, Day 5 and Day 6 post first dose administration

  4. Part A- PK of NP-201 acetate Injection metabolite- Time to Cmax,ss (tmax,ss)

    Plasma Pharmacokinetics in Healthy Volunteers following administration of multiple doses of NP-201 acetate injection by measuring the NP-201 acetate injection metabolite time to CMAX, ss (tmax, ss)

    Measured: Part A- Samples collected on Day 1, Day 2, Day 5 and Day 6 post first dose administration

  5. Part A-PK of NP-201 acetate injection metabolite- Apparent oral body clearance at steady state (CL/Fss)

    Plasma Pharmacokinetics in Healthy Volunteers following administration of multiple doses of NP-201 acetate injection by measuring the NP-201 acetate injection metabolite apparent oral body clearance at steady state (CL/Fss)

    Measured: Part A- Samples collected on Day 1, Day 2, Day 5 and Day 6 post first dose administration

  6. Part A- PK of NP-201 acetate injection metabolite- Apparent volume of distribution at steady-state (Vd/Fss),

    Plasma Pharmacokinetics in Healthy Volunteers following administration of multiple doses of NP-201 acetate injection by measuring the NP-201 acetate injection metabolite apparent volume distribution at steady state (Vd/Fss)

    Measured: Part A- Samples collected on Day 1, Day 2, Day 5 and Day 6 post first dose administration

  7. Part A-PK of NP-201 acetate Injection metabolite- terminal half-life (T1/2)

    Plasma Pharmacokinetics in Healthy Volunteers following administration of multiple doses of NP-201 acetate injection by measuring the NP-201 acetate injection metabolite terminal half-life (t1/2)

    Measured: Part A- Samples collected on Day 1, Day 2, Day 5 and Day 6 post first dose administration

  8. Part A-Metabolite PK parameters in Cohort MAD4-t½

    To evaluate metabolite t½ (Apparent terminal half-life)

    Measured: Part A-Day 1, Day 8, Day 15, Day 22, Day 29, Day 30, Day 43

  9. Part A-Metabolite PK parameters in Cohort MAD4-AUC

    To evaluate metabolite AUC (Area under the plasma concentration versus time curve)

    Measured: Part A-Day 1, Day 8, Day 15, Day 22, Day 29, Day 30, Day 43

  10. Part A-Metabolite PK parameters in Cohort MAD4- Cmax

    To evaluate metabolite Cmax (Peak Plasma Concentration)

    Measured: Part A-Day 1, Day 8, Day 15, Day 22, Day 29, Day 30, Day 43

  11. Part A-Metabolite PK parameters in Cohort MAD4- Tmax

    To evaluate metabolite Tmax (Time to maximum concentration)

    Measured: Part A-Day 1, Day 8, Day 15, Day 22, Day 29, Day 30, Day 43

  12. Part A-Metabolite PK parameters in Cohort MAD4- CL/Fss

    To evaluate metabolite CL/Fss (Apparent clearance)

    Measured: Part A-Day 1, Day 8, Day 15, Day 22, Day 29, Day 30, Day 43

  13. Part A-Metabolite PK parameters in Cohort MAD4- Vd/Fss

    To evaluate metabolite Vd/Fss (Apparent terminal volume of distribution)

    Measured: Part A-Day 1, Day 8, Day 15, Day 22, Day 29, Day 30, Day 43

Timeline

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

  1. First posted8 Nov 2024
  2. Study start25 Nov 2024
  3. Primary completion18 Jul 2025
  4. Study completion4 Sep 2025

Why it stopped: Study was terminated at the end of Part A for strategic reasons (not due to lack of efficacy or safety issues

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
Double blind
Who is masked
Participant, Investigator
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06681389
Sponsor's protocol ID
NIB-IBD-201
Status last verified
Jun 2026
First submitted
30 Oct 2024
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NP-201 acetate injection (Part A) in people with Healthy Adult Volunteers and Active Ulcerative Colitis, run by NIBEC 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 9 inclusion and 20 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: stopped early, as of the sponsor's last update on 23 Jun 2026. 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 was stopped early (reason given: Study was terminated at the end of Part A for strategic reasons (not due to lack of efficacy or safety issues). Results are not available in the source record.

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?

Safety of NP-201 acetate injection in Healthy Volunteers. To evaluate the safety of NP-201 acetate injection by incidence, relationship and severity of adverse events (AE), serious adverse events and Treatment emergent AE (time frame: Part A-Screening to Day 12 post first dose administration). The study lists 23 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 NCT06681389.

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 23 Jun 2026.

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