ANG-3070 in Healthy Adult Participants

• ClinicalTrials.gov Identifier: NCT04196179
• Recruitment Status: Recruiting
• First Posted: December 12, 2019
• Last Update Posted: January 3, 2020
• Sponsor: Angion Biomedica Corp
• Information provided by (Responsible Party): Angion Biomedica Corp

Study Description

Brief Summary:

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)

Condition or disease	Intervention/treatment	Phase
Idiopathic Pulmonary Fibrosis	Drug: ANG3070; Drug: Placebo oral capsule	Phase 1

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.

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)

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: December 17, 2019
• Estimated Primary Completion Date: August 2020
• Estimated Study Completion Date: November 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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;
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; 6

Contacts and Locations

Contacts

Contact: Shakil Aslam, MD; 857-263-5221; saslam@angion.com

Contact: Gabrielle Pelle; 516-326-1200; gpelle@angion.com

Locations

Australia

Nucleus Network, VIC; Recruiting

Melbourne, Australia, 3004

Sponsors and Collaborators

Angion Biomedica Corp

Investigators

• Study Director: Shakil Aslam, MD; Angion Biomedica

More Information

• Responsible Party: Angion Biomedica Corp
• ClinicalTrials.gov Identifier: NCT04196179
• Other Study ID Numbers: ANG-3070-001
• First Posted: December 12, 2019
• Last Update Posted: January 3, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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

Additional relevant MeSH terms:

Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases; Idiopathic Interstitial Pneumonias; Lung Diseases, Interstitial