Status:
TERMINATED
Safety, Tolerability, and Pharmacodynamics of NOV-001 in Adult Subjects
Lead Sponsor:
Novome Biotechnologies Inc
Conditions:
Healthy Volunteers
Enteric Hyperoxaluria
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
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 volunt...
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 biotherape...
Eligibility Criteria
Inclusion
- Stage 1 Key
- Ages 18 to 55
- Body mass index (BMI) \< 38 kg/m2.
- Healthy as defined by no clinically relevant abnormalities being identified by a detailed medical history, physical examination, and clinical laboratory tests.
- If woman of child-bearing potential, must not be pregnant, and must also agree to use an appropriate highly-effective contraceptive.
- 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.
- Stage 1 Key
Exclusion
- 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.
- Current or history of any clinically significant medical illness or disorder the Investigator considers should exclude the subject from the study.
- Participation in any investigational intervention study within 30 days prior to study product administration in this study.
- Known hypersensitivity to omeprazole.
- Applicable only to certain study groups depending on emerging Stage 1 data: no current or anticipated use during the screening or treatment periods of the study of medications that have the potential for drug-drug interactions (DDI) with omeprazole.
- Stage 2 Key Inclusion Criteria:
- Ages 18 to 65.
- Hyperoxaluria secondary to Roux-en-Y gastric bypass surgery or to biliopancreatic diversion with duodenal switch (BPD-DS) surgery.
- 24-Hour urinary oxalate (UOx) ≥ 60 mg.
- If woman of child-bearing potential, must not be pregnant and must also agree to use an appropriate highly effective contraceptive method.
- Must, in the opinion of the Investigator, be in otherwise good health.
- Willing and able to comply with all study requirements, including dietary restrictions, daily study product administration, pregnancy testing and contraception (if applicable), stool collections, and blood and 24-hour urine collections.
- Stage 2 Key
Key Trial Info
Start Date :
June 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2023
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT04909723
Start Date
June 2 2021
End Date
April 6 2023
Last Update
May 17 2023
Active Locations (20)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35205
2
Mayo Clinic
Scottsdale, Arizona, United States, 85259
3
Advanced Urology Institute
Daytona Beach, Florida, United States, 32114
4
Prohealth Research Center
Doral, Florida, United States, 33166