A Phase I, Single Ascending Dose, Safety and Pharmacokinetic Study of PN0621 in Healthy Volunteers

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000275460

Acronym

PN0621/100

Enrollment

Registered

2007-05-22

Start date

2007-05-21

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

To establish whether the adminstration to humans of the new anti-inflammatory drug PN0621 is safe. To determine the distribution of PN0621 in the human body to design dosing levels for future trials.

Interventions

PN0621 'IV-Intravenous' administation starting dose 5mg then increasing in new healthy volunteers for each dose through 10mg,20mg,40mg, 80mg and 160mg until a dose limiting toxicity is reached 'SC-subcutaneous' administration starting dose 20mg then increasing in new healthy volunteers for each dose through 40mg, 80mg, 160mg and 320mg until a dose limiting toxicity is reached.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 40 Years

Healthy volunteers

Inclusion criteria

BMI - Body mass Index' 19 to 29, nromal or clinically acceptable 'ECG - Electrocardiogram'

Exclusion criteria

Donation or loss of more than 400ml blood within 3 months of study, history of infection, screen positive to Tuberculosis, Hepatitis C, Hepatisis B or Human immunodeficiency virus (HIV)

Outcome results