NCT03399435 - A Study in Healthy Male Volunteers to Investigate the Safety and Tolerability of a Single Dose of Neosaxitoxin Alone and in Combination With Bupivacaine (With and Without Epinephrine) for Brachial Plexus Blockade | Biotech Hunter

Enrollment

242

Participants

Timeline

Start Date

January 30, 2018

Primary Completion Date

September 21, 2018

Study Completion Date

September 21, 2018

Conditions

AnesthesiaAnesthesia, LocalAnalgesia

Interventions

COMBINATION_PRODUCT

Neosaxitoxin combined with bupivacaine low and epinephrine (T1)

A single injection: Neosaxitoxin from 1.25 to 60 µg. Bupivacaine 40 mg. Epinephrine 100 µg.

COMBINATION_PRODUCT

Bupivacaine low combined with epinephrine (C1)

A single injection: Bupivacaine 40 mg. Epinephrine dose 100 µg.

COMBINATION_PRODUCT

Bupivacaine high combined with epinephrine (C2)

A single injection: Bupivacaine 100 mg. Epinephrine 100 µg.

COMBINATION_PRODUCT

Neosaxitoxin combined with bupivacaine low (T2)

A single injection: Neosaxitoxin from 1.25 to 60 μg. Bupivacaine from 10 to 80 mg.

DRUG

Bupivacaine low (C3)

A single injection: Bupivacaine from 10 to 80 mg.

DRUG

Bupivacaine high (C4)

A single injection: Bupivacaine 100 mg.

DRUG

Neosaxitoxin (T3)

A single injection: Neosaxitoxin will be between 1.25 and 60 µg.

COMBINATION_PRODUCT

Neosaxitoxin combined with epinephrine (T4)

A single injection: Neosaxitoxin will be between 1.25 and 60 μg. Epinephrine 100 µg.

COMBINATION_PRODUCT

Neosaxitoxin combined with bupivacaine low and epinephrine

A single injection: Neosaxitoxin will be between 1.25 to 60 µg. Bupivacaine dose based on results from Part B (10 to 80 mg). Epinephrine 100 µg.

COMBINATION_PRODUCT

Neosaxitoxin combined with bupivacaine low

A single injection: Neosaxitoxin will be between 1.25 to 60 μg. Bupivacaine dose based on results from Part B (10 to 80 mg).

Trial Locations (1)

NL001, Groningen