Last updated on January 2020

ANG-3070 in Healthy Adult Participants


Brief description of study

This is a Phase 1 study, to assess the safety, tolerability, pharmacokinetics, and food effect of single and multiple ascending doses of ANG-3070 in healthy adult participants.

This study is comprised of 10 cohorts. 6 single ascending dose (SAD) cohorts and 4 multiple ascending dose (MAD) cohorts.

Each cohort will have a total of 8 subjects: SAD and MAD (2 subjects receiving placebo and 6 subjects receiving active ANG 3070)

Detailed Study Description

This is a Phase 1 study, to assess the safety, tolerability, pharmacokinetics, and food effect of single and multiple ascending doses of ANG-3070 in healthy adult participants.

Each cohort will have a total of 8 subjects: SAD and MAD (2 subjects receiving placebo and 6 subjects receiving active ANG 3070). The study design employs sentinel dosing with 2 subjects (1 placebo, 1 active treatment) at least 24 hours prior to remainder of cohort for dose cohort 1.

SAD cohorts are defined as follows, with the FE crossover occurring for participants in cohort A3 on Day 15.

A1 ANG-3070 50 mg (n=6) / Placebo (n=2)

A2 ANG-3070 100 mg (n=6) / Placebo (n=2)

A3 ANG-3070 200 mg (n=6) / Placebo (n=2)

A3 Day 15** ANG-3070 200mg (n=6) / Placebo (n=2)

A4 ANG-3070 400 mg (n=6) / Placebo (n=2)

A5 Day 1 ANG-3070 800 mg (n=6) / Placebo (n=2)

A6 Day 1 ANG-3070 1200 mg (n=6) / Placebo (n=2)

MAD cohorts will receive drug or placebo twice daily for 7 consecutive days (Day 1 to Day 7) , or once daily for 14 (Day 1 to Day 14) are defined as follows:

B1 ANG-3070 50 mg (n=6) / Placebo (n=2)

B2 ANG-3070 100 mg (n=6) / Placebo (n=2)

B3 ANG-3070 250 mg (n=6) / Placebo (n=2)

Clinical Study Identifier: NCT04196179

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Recruitment Status: Open


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