A Phase I study of LJPC-401 in healthy adult volunteers

A Phase 1, Placebo-Controlled Study to Determine the Safety, Tolerability and Pharmacokinetics of Escalating Subcutaneous Doses of LJPC-401 in Healthy Adult Volunteers

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616000132448

Enrollment

Registered

2016-02-04

Start date

2016-02-02

Completion date

2016-03-14

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

A Phase I study of LJPC-401 in healthy adult volunteers. LJPC-401 is being developed to treat conditions characterized by iron overload, such as hemochromatosis and beta thalassemia. Bellberry Human Research Ethics Committee approval has been received.

Interventions

Single dose of LJPC-401 delivered subcutaneously. Planned ascending dose cohorts at 5mg, 18mg, 36, and 72mg. All doses will be administered on-site by study staff. A Data Monitoring Committee (DMC) comprised of the Principal Investigator (PI), the Sponsor’s medical representatives, and others as applicable, will meet periodically to review all treatment-emergent adverse events (TEAEs), and to make dose-escalation decisions.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

Normal, healthy volunteers, negative drug and alcohol tests, BMI 18-32 inclusive

Exclusion criteria

Blood pressure less than 90/60 or greater than 160/100, limited alcohol and tobacco use, infection or other serious underlying medical condition

Outcome results