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This Phase 1a/b, first-in-human, multiple dose-escalation, randomized, double-blinded, placebo-controlled study is evaluating SYNB8802 in healthy volunteers (HV) and subjects diagnosed with enteric hyperoxaluria (EH). Eligible subjects receive investigational product (IP) and undergo safety monitoring, evaluations, and subsequent follow-up after IP administration.
In Part 2, all evaluations and assessments throughout this study may be conducted either at the clinical site or by a home healthcare professional at an alternative location (e.g., EH patient's home, hotel).
Full description
This study is evaluating the safety, tolerability, kinetics, and pharmacodynamics of SYNB8802 within the following 2 study parts:
Part 1 is an inpatient, placebo-controlled, multiple ascending dose (MAD) study in HV male and female subjects in up to 5 dose cohorts (6 treated: 3 placebo) for 5 days of dosing to identify the maximum tolerated dose (MTD).
Part 2 is a placebo-controlled crossover study in up to 20 adult male and female subjects with EH secondary to Roux-en-Y bariatric surgery. Subjects will be randomized to receive either SYNB8802 (at or below the MTD from Part 1) or placebo for six days before crossing over to receive either placebo or SYNB8802 for another six days, respectively. This part of the study has been designed with the flexibility of being able to be conducted either at the clinical site or by a home healthcare professional at an alternative location (e.g., patient's home, hotel).
Enrollment
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Volunteers
Inclusion and exclusion criteria
Part 1 Inclusion Criteria:
Age ≥ 18 to ≤ 64 years.
Body mass index (BMI) 18.5 to 28 kg/m2.
Able and willing to voluntarily complete the informed consent process.
Available for and agree to all study procedures, including feces, urine, and blood collection and adherence to diet control, inpatient monitoring, follow-up visits, and compliance with all study procedures.
Male subjects who are sexually abstinent or surgically sterilized (vasectomy), or those who are sexually active with a female partner(s) and agree to use an acceptable method of contraception (such as a condom with spermicide) combined with an acceptable method of contraception for their non-pregnant female partner(s) (as defined in Inclusion Criterion # 6) after informed consent, throughout the study, and for a minimum of 3 months after the last dose of IMP, and who do not intend to donate sperm in the period from Screening until 3 months following administration of the investigational medical product.
Female subjects who meet 1 of the following:
i. Documented hysterectomy ii. Documented bilateral salpingectomy iii. Documented bilateral oophorectomy iv. Documented tubal ligation/occlusion v. Sexual abstinence is preferred or usual lifestyle of the subject c. Postmenopausal women (12 months or more amenorrhea verified by follicle- stimulating hormone [FSH] assessment and over 45 years of age in the absence of other biological or physiological causes).
Part 1 Exclusion Criteria:
Part 2 Inclusion Criteria:
Age ≥ 18 to ≤ 74 years.
Able and willing to voluntarily complete the informed consent process.
Available for and agree to all study procedures, including feces, urine, and blood collection and adherence to diet control, follow-up visits, and compliance with all study procedures.
Enteric hyperoxaluria secondary to Roux-en-Y bariatric surgery (at least 12 months post-surgery).
Urinary oxalate ≥ 70 mg/24 hours (mean of at least 2 urine collections during Screening).
Male subjects who are sexually abstinent or surgically sterilized (vasectomy), or those who are sexually active with a female partner(s) and agree to use an acceptable method of contraception (such as condom with spermicide) combined with an acceptable method of contraception for their non-pregnant female partner(s) (as defined in Inclusion Criterion # 7) after informed consent, throughout the study, and for a minimum of 3 months after the last dose of IMP, and who do not intend to donate sperm in the period from Screening until 3 months following administration of the investigational medical product.
Female subjects who meet 1 of the following:
i. Documented hysterectomy ii. Documented bilateral salpingectomy iii. Documented bilateral oophorectomy iv. Documented tubal ligation/occlusion v. Sexual abstinence is preferred or usual lifestyle of the subject c. Postmenopausal women (12 months or more amenorrhea verified by FSH assessment and over 45 years of age in the absence of other biological or physiological causes).
Screening laboratory evaluations (e.g., chemistry panel, complete blood count with differential, prothrombin time [PT]/activated partial thromboplastin time [aPTT], urinalysis) and electrocardiogram (ECG) must be within normal limits or judged to be not clinically significant by the investigator.
Part 2 Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
77 participants in 8 patient groups, including a placebo group
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Central trial contact
Richard Riese
Data sourced from clinicaltrials.gov
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