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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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This will be a double-blind, randomized, placebo-controlled, single ascending dose study performed in healthy subjects.
The study will include up to four escalating dose cohorts with eight (8) subjects in each cohort.
In each cohort, eligible subjects will be randomized in a 3:1 ratio to receive single IV administration of 9% trehalose (Treatment Arm 1) or placebo (Treatment Arm 2).
All subjects, regardless of their treatment arm assignment, will undergo the same evaluations and will receive the study drug at the clinic. Each subject will continue to be followed for one week post dosing.
This is a double-blind, randomized, placebo-controlled, single ascending dose study performed in healthy subjects.
The study will include up to four escalating dose cohorts with eight (8) subjects in each cohort.
In each cohort, eligible subjects will be randomized in a 3:1 ratio to receive single IV administration of 9% trehalose (Treatment Arm 1) or placebo (Treatment Arm 2).
All subjects, regardless of their treatment arm assignment, will undergo the same evaluations and will receive the study drug at the clinic. Each subject will continue to be followed for one week post dosing.
Cohorts 1 to 3 After all subjects in a given cohort complete their 1-week follow-up visit (Visit 4), a Safety Review Committee (SRC) will review the safety and PK data of that cohort. If no safety concerns are identified, and the exposure data supports a higher dose is acceptable, the SRC will approve continuation into the next cohort (dose level).
Cohort 4 Cohort 4 will be initiated based on review of the safety and exposure data from the first 3 cohorts by the SRC. This cohort will only be performed if there is a suggestion that exposure can be safely increased.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trehalose 9% | Experimental | Single dose administration of Trehalose 9% for IV infusion. |
|
| Saline 0.9% | Placebo Comparator | Single dose administration of 0.9% saline in the same volume and duration as Treatment Arm 1 (9% trehalose) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trehalose for IV Infusion | Drug |
| ||
| Saline 0.9% IV |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of escalating doses of intravenously administered trehalose (incidence of adverse events and serious adverse events, including clinically significant laboratory abnormalities) | Safety will be assessed by the incidence of adverse events and serious adverse events, including clinically significant laboratory abnormalities. | Will be assessed during the entire study. At screening, at day -1 before drug administration, and day 1 of drug administration before, during and after drug administration, and at day 8 the follow up visit |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum-tolerated dose (MTD) of trehalose administered intravenously (Averse events, vitals signs) | The maximum-tolerated dose of trehalose will be assessed by evaluating the safety and tolerability of each of the escalating trehalose doses | Will be assessed during the entire study. At screening, at day -1 before drug administration, and day 1 of drug administration before, during and after drug administration, and at day 8 the follow up visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PAREXEL Baltimore Early Phase Clinical Unit; Harbor Hospital | Baltimore | Maryland | 21225 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 9, 2017 | |
| Reset | Mar 29, 2017 | |
| Release | Jul 21, 2017 | |
| Unrelease | Yes | |
| Release | Aug 25, 2017 | |
| Reset | Mar 22, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 9, 2017 | Mar 29, 2017 | |||
| Jul 21, 2017 |
| ID | Term |
|---|---|
| D014199 | Trehalose |
| D007262 | Infusions, Intravenous |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D004187 | Disaccharides |
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|
| Pharmacokinetics (PK) of plasma and urine trehalose | To determine the pharmacokinetics (PK) of trehalose following administration of escalating doses of trehalose | Will be assessed on the day of drug administration, before drug administration and up to 12hours following administration. |
| Pharmacokinetics (PK) of serum and urine glucose | To determine the pharmacokinetics (PK) of glucose following administration of escalating doses of trehalose | Will be assessed on the day of drug administration, before drug administration and up to 12hours following administration. |
| Yes |
| Aug 25, 2017 | Mar 22, 2018 |
| D009844 |
| Oligosaccharides |
| D000073893 | Sugars |
| D061605 | Administration, Intravenous |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007263 | Infusions, Parenteral |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |