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NOV-001 for Healthy Subjects

Phase 1 & 2
Waitlist Available
Research Sponsored by Novome Biotechnologies Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up stage 2; 28 days
Awards & highlights

Study Summary

This trial is evaluating the safety and tolerability of NOV-001, as well as its effects on patients with enteric hyperoxaluria.

Eligible Conditions
  • Healthy Subjects
  • Enteric Hyperoxaluria

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~stage 2; 28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and stage 2; 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Other outcome measures
Absolute change from baseline in 24-hour urinary oxalate (UOx) excretion (mg/mL), NOV-001 compared to placebo.
Fecal shedding of NB1000S strain as measured by qPCR determination of concentration of NB1000S strain genomic copies (cells/mL), during treatment and follow-up periods.
NB1000S engraftment as measured by quantitative Polymerase Chain Reaction (qPCR) determination of concentration of NB1000S strain genomic copies (cells/mL) in stool, change from baseline.
+4 more

Trial Design

8Treatment groups
Experimental Treatment
Placebo Group
Group I: Stage 2 NOV-001 at dose determined in Stage 1Experimental Treatment1 Intervention
In Stage 2, subjects will be randomized (3:1, NOV-001:placebo) to receive NOV-001 (consisting of NB1000S and NB2000P at a dose and regimen determined in Stage 1) for 28 days.
Group II: Stage 1 NB2000P at a dose to be determinedExperimental Treatment1 Intervention
Group III: Stage 1 NB1000S 10^9 CFU one time on Day 1 and NB2000P 10g/dayExperimental Treatment1 Intervention
Group IV: Stage 1 NB1000S 10^9 CFU one time on Day 1 and NB2000P 0.5g/dayExperimental Treatment1 Intervention
Group V: Stage 1 NB1000S 10^9 CFU one time on Day 1Experimental Treatment1 Intervention
Group VI: (Optional) Stage 1 variable doses of NB1000S and NB2000P at varying dosing regimens.Experimental Treatment1 Intervention
Adaptive trial design supports the enrollment of additional arms with variable doses of NB1000S, NB2000P, at varying frequencies of NB1000S and NB2000P administrations.
Group VII: Stage 1 placebo armPlacebo Group1 Intervention
Group VIII: Stage 2 placebo armPlacebo Group1 Intervention
In Stage 2, subjects will be randomized (3:1, NOV-001:placebo) to receive placebo for 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NB2000P
2021
Completed Phase 2
~120
NOV-001
2021
Completed Phase 2
~120
NB1000S
2021
Completed Phase 2
~120

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Novome Biotechnologies IncLead Sponsor
Lachy McLean, MB ChB, PhDStudy DirectorNovome Biotechnologies Inc

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to partake in this clinical investigation?

"To qualify for the trial, applicants must illustrate healthy subjectivity (HS) and fall within the 18 - 65 age bracket. A total of 115 participants are being recruited."

Answered by AI

Are there any available openings in this experimentation for volunteers?

"Clinicaltrials.gov specifies that this clinical trial is actively seeking participants, with the initial post being published on June 2nd 2021 and a recent update occurring on November 11th 2022."

Answered by AI

How many healthcare centers are partaking in this research endeavor?

"Patients can be recruited from Chesapeake Urology Associates in Hanover, Maryland, University of Iowa Hospitals and Clincs in Iowa City, Iowa, Idaho Urologic Institute in Meridian, Idaho among 20 other sites."

Answered by AI

How many individuals have volunteered for this research initiative?

"Yes, the research hosted on clinicaltrials.gov reveals that this trial is currently accepting participants. It was initially published on June 2nd 2021 and its parameters were changed as recently as November 11th 2022. This medical experiment requires 115 individuals to be recruited from 19 distinct sites."

Answered by AI

Is the enrollment criteria for this clinical trial inclusive of persons aged 60 and over?

"As specified in the qualification parameters of this clinical trial, patient must be no younger than 18 and not older than 65 years old."

Answered by AI

Who else is applying?

What state do they live in?
New York
Ohio
North Carolina
Other
How old are they?
18 - 65
What site did they apply to?
Prohealth Research Center
Associated Urologists of North Carolina
Other
Houston Metro Urology
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

How responsive is this trial?

Most responsive sites:
  1. Houston Metro Urology: < 24 hours
Typically responds via
Phone Call
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
Safety, Tolerability, and Pharmacodynamics of NOV-001 in Adult Subjects
2021. "Safety, Tolerability, and Pharmacodynamics of NOV-001 in Adult Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04909723.
~30 spots leftby Apr 2025
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