CompletedPhase 1

Safety, Tolerability and Pharmacodynamics of SYNB1353 in Healthy Adult Volunteers

United States31 participantsStarted 2022-07-07

Plain-language summary

This is a Phase 1, double-blind (Sponsor-open), placebo-controlled, randomized, dose-escalation, inpatient study using a multiple-ascending dose (MAD) design to assess the safety, tolerability, and PD of SYNB1353 in HVs.

Who can participate

Age range18 Years – 64 Years

SexALL

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Inclusion criteria

✓. Age ≥ 18 to ≤ 64 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, 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 # 5) 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 IMP.
✓. Female subjects who meet 1 of the following:
✓. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test (human chorionic gonadotropin) at Screening and a negative urine pregnancy test at baseline prior to the start of IMP and must agree to use acceptable method(s) of contraception, combined with an acceptable method of contraception for their male partner(s) (as defined in Inclusion Criterion # 4) after informed consent, throughout the study and for a minimum of 3 months after the last dose of IMP. Acceptable methods of contraception include hormonal contraception, hormonal or non-hormonal intrauterine device, bilateral tubal occlusion, complete abstinence, and/or vasectomized partner with documented azoospermia 3 months after procedure.
✓. WOCBP must not be breastfeeding.
✓. Premenopausal women with at least 1 of the following:

Exclusion criteria

✕. Acute or chronic medical, surgical, psychiatric, or social condition or laboratory abnormality that may increase subject risk associated with study participation, compromise adherence to study procedures and requirements, or may confound interpretation of study safety or PD results and, in the judgment of the Investigator, would make the subject inappropriate for enrollment.
✕. Body mass index \< 18.5 or ≥ 35 kg/m2.
✕. History of or current immunodeficiency disorder including human immunodeficiency virus (HIV) antibody positivity.
✕. Hepatitis B surface antigen positivity (subjects with hepatitis B surface antibody positivity and hepatitis B core antibody positivity are not excluded, provided that the hepatitis B surface antigen is negative).
✕. Hepatitis C antibody positivity, unless a hepatitis C virus ribonucleic acid test is performed, and the result is negative.
✕. History of febrile illness, confirmed bacteremia, or other active infection deemed clinically significant by the Investigator within 30 days prior to the anticipated first dose of IMP.
✕. History of (within the past month) passage of 3 or more loose stools per day, where "loose stool" is defined as a Type 6 or Type 7 on the Bristol Stool Chart (see Appendix 1).
✕. Inflammatory or irritable bowel disorder of any grade experienced within the previous 60 days.

What they're measuring

Number of participants with abnormal laboratory values and/or adverse events

Timeframe: Day -2 through Day 8

Trial details

NCT IDNCT05462132

SponsorSynlogic

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-11-27

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