A First-in-Human Study of FLX475 in Healthy Volunteers

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation, Multiple-Dose Escalation, and Food Effect Study of FLX475 in Healthy Male and Female Subjects

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26146

Enrollment

104

Registered

2018-08-15

Start date

2017-11-17

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Healthy human volunteers (preliminary safety study) Cancer

Interventions

FLX475

Eligibility

Inclusion criteria

Inclusion criteria: Healthy Male or Female 18-55 years of age, inclusive At least 50 kg in weight BMI: 18.0-30.0 kg/m2, inclusive Non-smoking

Exclusion criteria

Exclusion criteria: Use of tobacco products within 60 days prior to drug administration History of alcohol abuse or drug addiction Positive drug and alcohol screen Participation in a drug study within 60 days prior to drug administration Donation or loss of more than 100 mL of blood within 60 days prior to drug administration. Donation or loss of more than 1.5 liters of blood (for male subjects) / more than 1.0 liters of blood (for female subjects) in the 10 months prior to drug administration.

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of single and multiple oral ascending doses of FLX475 administered to healthy male and female subjects	—

Secondary

Measure	Time frame
Pharmacokinetics of FLX475 (capsule and tablet formulation) Food effect	—

Contacts

Public ContactWilliam Ho

bill.ho@flxbio.com

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)