Safety and pharmacokinetic study of ACV1, a potential neuropathic pain treatment.

A Randomised, Placebo-Controlled, Double-Blind, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous Doses of ACV1 in Healthy Adult Male Subjects.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000408684

Acronym

N/A

Enrollment

Registered

2005-09-14

Start date

2005-06-23

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary purpose of this study is to assess the safety and tolerability of subcutaneous doses of ACV1 in healthy adult males.

Interventions

Randomised, placebo-controlled, double-blind, single and mutliple (7 day) ascending dose, Phase 1 study of subcutaneous ACV1 in healthy adult male volunteers.

Study design

Allocation

Randomised controlled trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

Male

Age

18 Years to 49 Years

Healthy volunteers

Yes

Inclusion criteria

Weight <= 100 kg, BMI 19 to 30, generally healthy, adequate venous access, fluent English, have given written informed consent.

Exclusion criteria

Hypersensitivity, medical conditions, organ dysfunction, drug or alcohol abuse, taking medication.

Outcome results