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Trial record 1 of 1 for:    NCT04909723
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Safety, Tolerability, and Pharmacodynamics of NOV-001 in Adult Subjects

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ClinicalTrials.gov Identifier: NCT04909723
Recruitment Status : Recruiting
First Posted : June 2, 2021
Last Update Posted : June 25, 2021
Sponsor:
Information provided by (Responsible Party):
Novome Biotechnologies Inc

Brief Summary:

The first stage of this study is a prospective, adaptive, Phase 1, first-in-human, randomized, controlled study evaluating safety, tolerability, and pharmacodynamics of NOV-001 in adult healthy volunteers.

The second stage of this study is a prospective, randomized, single-blinded, placebo-controlled study of safety, tolerability, and early efficacy in patients with enteric hyperoxaluria.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Combination Product: NOV-001 Biological: NB1000S Drug: NB2000P Drug: Placebo Phase 1

Detailed Description:
This study is evaluating the safety, tolerability, pharmacodynamics, and early efficacy of NOV-001. NOV-001 is an investigational combination product composed of NB1000S, a recombinant live biotherapeutic product, and NB2000P, a botanically derived polysaccharide. NB1000S is anticipated to be administered once on the first day of treatment (or potentially more than once daily over the first days of treatment) and NB2000P is administered once daily for 14 days at variable doses as determined in this adaptive study design.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Phase 1-2a Safety, Tolerability, and Pharmacodynamics Controlled Study of NOV-001 in Healthy Volunteers and Patients With Enteric Hyperoxaluria
Actual Study Start Date : June 2, 2021
Estimated Primary Completion Date : September 13, 2021
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Placebo

Experimental: NB1000S 10^9 CFU one time on Day 1 Biological: NB1000S
A recombinant live biotherapeutic product.

Experimental: NB1000S 10^9 CFU one time on Day 1 and NB2000P 0.5g/day Combination Product: NOV-001
NOV-001 is an investigational combination product composed of NB1000S, a recombinant live biotherapeutic product, and NB2000P, a botanically derived polysaccharide.

Experimental: NB1000S 10^9 CFU one time on Day 1 and NB2000P 10g/day Combination Product: NOV-001
NOV-001 is an investigational combination product composed of NB1000S, a recombinant live biotherapeutic product, and NB2000P, a botanically derived polysaccharide.

Experimental: (Optional) Variable doses of NB1000S and NB2000P at varying dosing regimens.
Adaptive trial design supports the enrollment of additional arms with variable doses of NB1000S, NB2000P, at varying frequencies of NB1000S administrations.
Combination Product: NOV-001
NOV-001 is an investigational combination product composed of NB1000S, a recombinant live biotherapeutic product, and NB2000P, a botanically derived polysaccharide.

Experimental: NB2000P at a dose to be determined Drug: NB2000P
A botanically derived polysaccharide.




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 [ Time Frame: Up to 182 days ]

Other Outcome Measures:
  1. 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. [ Time Frame: Up to 182 days ]
  2. The proportion of subjects with NB100S strain abundance in stool, as measured by qPCR determination of concentration of strain genomic copies (cells/mL). [ Time Frame: Up to 182 days ]
  3. Time to strain engraftment, based on the time to reach NB1000S strain abundance by qPCR determination of concentration of NB1000S strain genomic copies (cells/mL). [ Time Frame: Up to 182 days ]
  4. 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. [ Time Frame: Up to 182 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body mass index (BMI) < 38 kg/m2.
  • Healthy as defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including vital signs, and clinical laboratory tests.
  • If woman of child-bearing potential, must not be pregnant as confirmed by a negative pregnancy test (serum beta-human chorionic gonadotropin [hCG]) prior to study enrollment, and must also agree to use an appropriate highly-effective contraceptive method for the duration of treatment with study product and for 12 weeks after cessation of study product treatment.
  • Willing and able to comply with all study requirements, including duration of stay at inpatient unit, dietary restrictions, daily study product administration, pregnancy testing and contraception (if applicable), stool collections, and blood and urine collections.
  • Able to understand the requirements of this study and has provided written informed consent for participation in the study.

Exclusion Criteria:

  • Breast-feeding or anticipated to be breast-feeding during the treatment period.
  • Current or history of drug-dependency or drug abuse.
  • Positive results from urine drug screen during Screening and at baseline.
  • History of regular alcohol consumption above threshold within 3 months prior to Screening.
  • Estimated glomerular filtration rate (eGFR) < 80 mL/min/1.73 m2 at Screening.
  • Oral or parenteral antibiotics within 4 weeks prior to Screening, or anticipation of the need for such antibiotics during the Screening or treatment periods of the study.
  • Known ongoing clinically significant renal disease.
  • Current clinical diagnosis of chronic diarrhea or constipation.
  • Positive pregnancy test during Screening.
  • Unable to tolerate venipuncture.
  • Known bleeding disorder or history of prolonged bleeding or easy bruising.
  • Current or history of any clinically significant medical illness or disorder the Investigator considers should exclude the subject from the study.
  • Any acute or chronic medical condition that, in the opinion of the Investigator, increases the risk to the subject or the likelihood that the subject will be unable to complete the full duration of the study.
  • Unable or unwilling to comply with all requirements of the protocol.
  • Participation in any investigational intervention study within 30 days prior to study product administration in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04909723


Contacts
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Contact: Richard Yocum, MD 415-894-0999 ryocum@novomebio.com

Locations
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United States, Tennessee
AMR Knoxville Recruiting
Knoxville, Tennessee, United States, 37920
Contact: William Smith    865-305-9100      
Sponsors and Collaborators
Novome Biotechnologies Inc
Investigators
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Study Director: Richard Yocum, MD Novome Biotechnologies Inc
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Responsible Party: Novome Biotechnologies Inc
ClinicalTrials.gov Identifier: NCT04909723    
Other Study ID Numbers: NOV-001-CL01
First Posted: June 2, 2021    Key Record Dates
Last Update Posted: June 25, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novome Biotechnologies Inc:
Healthy volunteers
Safety
Tolerability