ANG-3070 in Healthy Adult Participants

A Phase 1, Randomized, Double-Blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Determine the Safety, Tolerability, Pharmacokinetics, and Food Effect of ANG-3070 in Healthy Adult Participants

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 12 cohorts. 5 single ascending dose (SAD) cohorts 6multiple ascending dose (MAD) cohorts, and 1 single dose food effect (FE) cross-over cohort Each cohort will have a total of 8 subjects: SAD and MAD (2 subjects receiving placebo and 6 subjects receiving active ANG-3070)

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: ANG3070; Drug: Placebo oral capsule

Detailed 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 and in cohort D1 on Day 5:

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 15ANG-3070 200mg (n=6) / Placebo (n=2) A4 ANG-3070 400 mg (n=6) / Placebo (n=2) A5 Day 1 ANG-3070 600 mg (n=6) / Placebo (n=2) D1 Day 1 ANG-3070 600 mg Single Dose (n=6) / Placebo (n=2) D1 Day 5 (ANG-3070 600 mg Single Dose (n=6) / Placebo (n=2)

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

B1 ANG-3070 50 mg BID (n=6) / Placebo (n=2) B2 ANG-3070 100 mg BID (n=6) / Placebo (n=2) B3 ANG-3070 250 mg BID (n=6) / Placebo (n=2) B4 ANG-3070 500 mg BID (n=6) / Placebo (n=2) C1 ANG-3070 400 mg QD (n=6) / Placebo (n=2) C2 ANG-3070 600 mg QD (n=6) / Placebo (n=2)

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Melbourne, Australia, 3004
    • Nucleus Network, VIC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy male or female volunteers, aged 18 to 65 years (inclusive at the time of informed consent);
2. Participants must be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at Screening and/or before administration of the initial dose of study drug; and
3. Participants must have a minimum body weight of 50 kg and a Body Mass Index (BMI) between ≥18.0 and ≤32.0 kg/m2 at Screening;

Exclusion Criteria:

1. Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period;
2. Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the Investigator's (or delegate's) opinion, could adversely affect the safety of the participant;
3. History of gastrointestinal (GI) disorders such as celiac disease, atrophic gastritis, lactose intolerance, and Helicobacter (H.) pylori infection;
4. Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the participant will comply with the protocol or complete the study per protocol;
5. Any surgical or medical condition that could interfere with the absorption, distribution, metabolism, or excretion of the study drug;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAD; A1 Day 1 ANG-3070 50 mg (n=6) / Placebo (n=2) Oral A2 Day 1 ANG-3070 100 mg (n=6) / Placebo (n=2) Oral A3 Day 1 ANG-3070 200 mg (n=6) / Placebo (n=2) Oral Day 15 ANG-3070 200mg (n=6) / Placebo (n=2) Oral A4 Day 1 ANG-3070 400 mg (n=6) / Placebo (n=2) Oral A5 Day 1 ANG-3070 600 mg (n=6) / Placebo (n=2) Oral D1 Single Dose Food Effect: Day 1 ANG 3070 600 mg *with and without food* (n=6)/ Placebo (n=2) Oral	Drug: ANG3070; ANG-3070 drug product is a an immediate release oral solid. The drug product consists of a Size 00 Swedish orange capsule containing drug substance (10 mg, 50 mg, or 250 mg) with no excipients.; Drug: Placebo oral capsule; ANG-3070 placebo capsules visually match the drug product.
Experimental: MAD; B1 ANG-3070 50 mg BID (n=6) / Placebo (n=2) B2 ANG-3070 100 mg BID (n=6) / Placebo (n=2) B3 ANG-3070 250 mg BID (n=6) / Placebo (n=2) B4 ANG-3070 500 mg, BID (n=6)/ Placebo (n=2) C1 ANG-3070 400 mg, QD(n=6)/ Placebo (n=2) C2 ANG-3070 600 mg, QD (n=6)/ Placebo (n=2)	Drug: ANG3070; ANG-3070 drug product is a an immediate release oral solid. The drug product consists of a Size 00 Swedish orange capsule containing drug substance (10 mg, 50 mg, or 250 mg) with no excipients.; Drug: Placebo oral capsule; ANG-3070 placebo capsules visually match the drug product.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Adverse Events	Difference versus placebo in the number of subjects with adverse events to evaluate safety and tolerability of ANG3070.	Up to the Follow Up visit 8 days after the last study drug administration
Difference in Vital Signs	Difference versus placebo in the number of subjects with abnormal vital signs to evaluate safety and tolerability of ANG3070.	Up to the Follow Up visit 8 days after the last study drug administration
Difference in Physical Exam	Difference versus placebo in the number of subjects with abnormal Physical examination to evaluate safety and tolerability of ANG3070	Up to the Follow Up visit 8 days after the last study drug administration
Difference in Lab Values	Difference versus placebo in the number of subjects with abnormal lab values to evaluate safety and tolerability of ANG3070.	Up to the Follow Up visit 8 days after the last study drug administration
Difference in ECG QT interval	Difference versus placebo in the number of subjects with abnormal ECG QT interval to evaluate safety and tolerability of ANG3070	Up to the Follow Up visit 8 days after the last study drug administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess PK	To assess the pharmacokinetics (PK) of single and multiple ascending doses of ANG-3070 and to evaluate the effect of a high fat meal on the PK of a single dose of ANG-3070 administered to healthy adult participants	Up to the Follow Up visit 8 days after the last study drug administration

Collaborators and Investigators

• Sponsor: Angion Biomedica Corp
• Investigators: Study Director: Shakil Aslam, MD, Angion Biomedica

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2019
• Primary Completion (Actual): November 27, 2020
• Study Completion (Actual): March 10, 2021

Study Registration Dates

• First Submitted: December 9, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (Actual): December 12, 2019

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: ANG-3070-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes