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ANG-3070 in Healthy Adult Participants

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ClinicalTrials.gov Identifier: NCT04196179
Recruitment Status : Recruiting
First Posted : December 12, 2019
Last Update Posted : October 26, 2020
Sponsor:
Information provided by (Responsible Party):
Angion Biomedica Corp

Study Description
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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 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)


Condition or disease Intervention/treatment Phase
Healthy Volunteers 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 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 Design
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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 : December 2020
Estimated Study Completion Date : December 2020
Arms and Interventions
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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.


Outcome Measures
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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


Secondary Outcome Measures :
  1. Assess PK [ Time Frame: Up to the Follow Up visit 8 days after the last study drug administration ]
    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


Eligibility Criteria
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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; 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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04196179


Contacts
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Contact: Shakil Aslam, MD 857-263-5221 saslam@angion.com
Contact: Gabrielle Pelle 516-326-1200 gpelle@angion.com

Locations
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Australia
Nucleus Network, VIC Recruiting
Melbourne, Australia, 3004
Sponsors and Collaborators
Angion Biomedica Corp
Investigators
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Study Director: Shakil Aslam, MD Angion Biomedica
More Information
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Responsible Party: Angion Biomedica Corp
ClinicalTrials.gov Identifier: NCT04196179    
Other Study ID Numbers: ANG-3070-001
First Posted: December 12, 2019    Key Record Dates
Last Update Posted: October 26, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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