A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of NPT189 in Healthy Subjects

A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of NPT189 in Healthy Subjects - Phase 1 Single Ascending Dose Study Evaluating NPT189 in Healthy Volunteers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46311

Enrollment

Registered

2018-06-21

Start date

2018-07-02

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Amyloïdose Amyloidosis

Interventions

NPT189 and placebo will be given as an intravenous infusion (solution of the compound that will be administered directly in a blood vessel). The infusion will take about an hour. Whether the volunt

*the study is blinded*. However, if it is important for volunteers health, for example in case of a serious adverse event, this information can be looked up during the study. Please refer to the

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Healthy male or female subjects -18-65 yrs, inclusive -BMI: 18-32 kg/m2, inclusive -Weight >= 45kg 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 a single IV infusion of NPT189.	—

Secondary

Measure	Time frame
To evaluate the pharmacokinetics (PK) of a single IV infusion of NPT189.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)