Healthy Volunteer Clinical Trial
Official title:
A Phase 1, First-in-human, Oral Single and Multiple Dose-Escalation, Randomized, Double-blinded, Placebo-controlled Study of SYNB1020 in Healthy Adult Volunteers to Evaluate Safety, Tolerability, Dosing, and Pharmacodynamics
A Phase 1, First-in-human, Oral Single and Multiple Dose-Escalation, Randomized, Double-blinded, Placebo-controlled Study of SYNB1020 in Healthy Adult Volunteers to Evaluate Safety, Tolerability, Dosing, and Pharmacodynamics
This Phase 1, dose-escalating, randomized, double-blinded study will evaluate SYNB1020 in placebo-controlled cohorts within the following 2 study parts: Part 1: A single-ascending dose (SAD) study conducted in an inpatient setting over 6 days in healthy volunteer male and female subjects evaluated in up to 7 dose cohorts to identify the maximum tolerated dose (MTD) within the single dose range studied; and Part 2: A multiple-ascending dose (MAD) study conducted in an inpatient setting over 22 days in healthy volunteer male and female subjects evaluated in up to 4 dose cohorts that were proven tolerable in the SAD part of the study to identify the MTD of SYNB1020 within the multiple-dose range studied. Up to 48 subjects may be enrolled in this part of the study. Subjects will be screened for eligibility within 30 days prior to enrollment, with evaluations of exercise habits, gastrointestinal (GI) signs and symptoms, fecal patterns (frequency, consistency), recent or current antibiotic exposure, and laboratory measurements. Eligible patients will be admitted to an inpatient facility for investigational product (IP) administration, safety monitoring, and collection of blood, urine, and fecal samples for pharmacokinetic and pharmacodynamic evaluations. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT06326723 -
Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects
|
Phase 1 | |
| Recruiting |
NCT00001367 -
Diagnosis and History Study of Patients With Different Neurological Conditions
|
||
| Completed |
NCT02699710 -
Effect of Food, Rabeprazole, Methotrexate and Formulation on the Pharmacokinetics (PK) of GDC-0853 and the Effect of GDC-0853 on the PK of Methotrexate in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT02231892 -
Repetitive Transcranial Magnetic Stimulation Equipment Testing and Pilot Study
|
N/A | |
| Completed |
NCT03771586 -
A Study to Assess the Electrophysiology, Safety, Tolerability, and Pharmacokinetics of SAGE-718 Using a Ketamine Challenge in Healthy Subjects
|
Phase 1 | |
| Not yet recruiting |
NCT06337422 -
Bioequivalence Study of Generic Celecoxib 200 mg Capsules
|
Phase 1 | |
| Completed |
NCT03302182 -
Bioequivalence Study of Ritonavir Versus NORVIR in Healthy Chinese Subjects
|
Phase 1 | |
| Completed |
NCT05049343 -
Study of SAGE-904 Using a Ketamine Challenge to Evaluate Electrophysiology, Safety, Tolerability, and Pharmacokinetics in Healthy Participants
|
Phase 1 | |
| Recruiting |
NCT01629108 -
Normal Values in Hearing and Balance Testing
|
||
| Completed |
NCT02947854 -
Study to Assess Safety, Tolerability and Immune Response of Fimaporfin-induced Photochemical Internalisation of Antigen/Adjuvant
|
Phase 1 | |
| Completed |
NCT02534870 -
Pharmacokinetics and Safety of the Co-administration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Healthy Chinese Subjects
|
Phase 1 | |
| Completed |
NCT02224053 -
Drug-Drug Interaction Study With AZD9291 and Omeprazole in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT01684891 -
A 28-Day Pharmacokinetics Study of RG1662 in Healthy Male Volunteers
|
Phase 1 | |
| Completed |
NCT01711762 -
A Pharmacokinetics Study of Radioactive-Labeled GDC-0973 in Healthy Male Volunteers
|
Phase 1 | |
| Completed |
NCT01697436 -
A Bioequivalence Study of an Oral Solution of Copegus (Ribavirin) Compared to Copegus Tablets
|
Phase 1 | |
| Completed |
NCT01676584 -
A Study of Single Dose RO6811135 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT01414881 -
Study to Assess the Effects of Mipomersen on Lipid and Lipoprotein Metabolism in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT01433575 -
A Pharmacokinetic Study of RO4917838 in Healthy Chinese Volunteers
|
Phase 1 | |
| Completed |
NCT01591850 -
A Drug-Drug Interaction Study of Ketoconazole, Rifampicin and Ritonavir-Boosted Atazanavir With Single-Dose RO5093151 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT02547259 -
Influence of Emotion in a Test Run Forgetfulness
|
N/A |