A first-in-human, randomized, dose-Escalation, double-blind, placebo-controlled study to assess safety, tolerability and pharmacokinetics of APX001 administered by intravenous infusion to healthy subjects.

A first-in-human, randomized, dose-Escalation, double-blind, placebo-controlled study to assess safety, tolerability and pharmacokinetics of APX001 administered by intravenous infusion to healthy subjects. - APX001 First in human study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46244

Enrollment

120

Registered

2016-04-26

Start date

2016-05-19

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Fungal diseases.

Interventions

SAD: Cohort 1: 1 x 10 mg Cohort 2: 1 x 30 mg Cohort 3: 1 x 100 mg Cohort 4: 1 x 300 mg Cohort 5: 1 x 525 mg Cohort 6: 1 x 800 mg MAD: Cohort 7: 1 x 50 mg Cohort 8: tbd x tbc mg Cohort 9: tbc x tbc m

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male or female volunteers 18 - 55 years, inclusive BMI 18.0 - 30.0 kilogram/meter2 non smoking

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, tolerability, and pharmacokinetics of single and multiple doses of APX001 administered by intravenous infusion in healthy volunteers.	—

Secondary

Measure	Time frame
1. Determine the maximum tolerated dose. 2. Explore the APX001 safety profile in relation to the duration of infusion observed at APX001A target plasma exposures (AUC24) required for clinical efficacy. 3. Explore the APX001 dose and dose regimen required to attain APX001A target plasma exposures (AUC24) required for clinical efficacy against Candida, Aspergillus and the hard-to-treat rare Molds (Scedosporium, Fusarium and Mucorales) invasive fungal infections.	—

Measure

Time frame

1. Determine the maximum tolerated dose. 2. Explore the APX001 safety profile in relation to the duration of infusion observed at APX001A target plasma exposures (AUC24) required for clinical efficacy. 3. Explore the APX001 dose and dose regimen required to attain APX001A target plasma exposures (AUC24) required for clinical efficacy against Candida, Aspergillus and the hard-to-treat rare Molds (Scedosporium, Fusarium and Mucorales) invasive fungal infections.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)