A phase I randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability and pharmacokinetics of NPT189 in healthy subjects

A phase I randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability and pharmacokinetics of NPT189 in healthy subjects - Study to evaluate the safety, tolerability and PK of NPT189

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48151

Enrollment

Registered

2019-02-05

Start date

2019-02-12

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Amyloïdose Amyloidosis

Interventions

NPT189 or placebo will be given as an intravenous infusion (solution of the compound that will be administered directly in a blood vessel), once per period. The infusion will take about an hour. Wh

we call this a double-blinded study. However, if it is important for the volunteers health, for example in case of a serious side effect, this information can be looked up during the study. For sa

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - healthy males and females - 18-65 years, inclusive - Weight >= 45 kg and

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
- To evaluate the safety and tolerability of repeated IV infusions of NPT189	—

Secondary

Measure	Time frame
- To evaluate the PK profile of NPT189 after repeated IV infusions	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)